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1.  A Randomised Placebo-Controlled Trial of a Traditional Chinese Herbal Formula in the Treatment of Primary Dysmenorrhoea 
PLoS ONE  2007;2(8):e719.
Background
Most traditional Chinese herbal formulas consist of at least four herbs. Four-Agents-Decoction (Si Wu Tang) is a documented eight hundred year old formula containing four herbs and has been widely used to relieve menstrual discomfort in Taiwan. However, no specific effect had been systematically evaluated. We applied Western methodology to assess its effectiveness and safety for primary dysmenorrhoea and to evaluate the compliance and feasibility for a future trial.
Methodology/Principal Findings
A randomised, double-blind, placebo-controlled, pilot clinical trial was conducted in an ad hoc clinic setting at a teaching hospital in Taipei, Taiwan. Seventy-eight primary dysmenorrheic young women were enrolled after 326 women with self-reported menstrual discomfort in the Taipei metropolitan area of Taiwan were screened by a questionnaire and subsequently diagnosed by two gynaecologists concurrently with pelvic ultrasonography. A dosage of 15 odorless capsules daily for five days starting from the onset of bleeding or pain was administered. Participants were followed with two to four cycles for an initial washout interval, one to two baseline cycles, three to four treatment cycles, and three follow-up cycles. Study outcome was pain intensity measured by using unmarked horizontal visual analog pain scale in an online daily diary submitted directly by the participants for 5 days starting from the onset of bleeding or pain of each menstrual cycle. Overall-pain was the average pain intensity among days in pain and peak-pain was the maximal single-day pain intensity. At the end of treatment, both the overall-pain and peak-pain decreased in the Four-Agents-Decoction (Si Wu Tang) group and increased in the placebo group; however, the differences between the two groups were not statistically significant. The trends persisted to follow-up phase. Statistically significant differences in both peak-pain and overall-pain appeared in the first follow-up cycle, at which the reduced peak-pain in the Four-Agents-Decoction (Si Wu Tang) group did not differ significantly by treatment length. However, the reduced peak-pain did differ profoundly among women treated for four menstrual cycles (2.69 (2.06) cm, mean (standard deviation), for the 20 women with Four-Agents-Decoction and 4.68 (3.16) for the 22 women with placebo, p = .020.) There was no difference in adverse symptoms between the Four-Agents-Decoction (Si Wu Tang) and placebo groups.
Conclusion/significance
Four-Agents-Decoction (Si Wu Tang) therapy in this pilot post-market clinical trial, while meeting the standards of conventional medicine, showed no statistically significant difference in reducing menstrual pain intensity of primary dysmenorrhoea at the end of treatment. Its use, with our dosage regimen and treatment length, was not associated with adverse reactions. The finding of statistically significant pain-reducing effect in the first follow-up cycle was unexpected and warrants further study. A larger similar trial among primary dysmenorrheic young women with longer treatment phase and multiple batched study products can determine the definitive efficacy of this historically documented formula.
Trial Registration
Controlled-Trials.com ISRCTN23374750
doi:10.1371/journal.pone.0000719
PMCID: PMC1940310  PMID: 17710126
2.  The effect of aquatic exercises on primary dysmenorrhoea in nonathlete girls 
Background:
Primary dysmenorrhoea without any specific pelvic disease is one of the common complaints in women`s medicine. The general purpose of this research is to define the effects of 12-week aquatic exercises on nonathletic girls’ primary dysmenorrhoea.
Materials and Methods:
This quasi-experimental was conducted on 40 nonathletic girls aged 18-25 years. Data gathering tools were: Evaluation form of primary dysmenorrhoea and the pain evaluation tool based on the McGill standard pain questionnaire completed before and after the intervention in 3 months (first, second, and third run). Then, 20 subjects were assigned to aquatic exercise group and the other 20 to control group. The subjects in experimental group did aquatic exercise for three sessions a week for 60 minutes for 12 weeks between two menstruations. Kruskal — Wallis and one way analysis of variance (ANOVA) tests were used to analyze the data.
Results:
The results of this research indicated that severity and duration of pain decreased after 12 weeks of aquatic exercises. Comparison of the two groups showed a significant difference in pain intensity based on visual analogue scale (VAS) scale after these exercises (first, second, and third runs). Present pain intensity (PPI) scale after these exercises (second and third runs) showed a significant difference. Comparison of the two groups showed a significant difference in length of pain after these exercises (third run).
Conclusions:
Totally, the findings of the present study showed that 12-week regular aquatic exercises are effective on decrease of the severity of the symptoms of primary dysmenorrhoea.
PMCID: PMC3877460  PMID: 24403940
Exercise therapy; Iran; primary dysmenorrhea
3.  Effect of fennel on pain intensity in dysmenorrhoea: A placebo-controlled trial 
Ayu  2012;33(2):311-313.
The aim of this study was to determine the clinical effect of Foeniculum vulgare on primary dysmenorrhoea. Sixty virgin girls with complaints of dysmenorrhoea were enrolled in this study, out of which 50 cases were completed the course of treatment and were divided in two groups (study and placebo) and were under treatment for two cycles. In study group a capsule of 30 mg fennel extract, four times a day for three days from start of their menstrual period and in placebo a capsule containing wheat flour in same dose was administered. Intensity of pain was reported by using a 10 - point linear analogue technique. In study group the mean age of menarche was 13.1 ± 0.1 and onset age of dysmenorrhoea was 14.5 ± 0.1 years. Both groups were relieved but there was significant difference between study and placebo group. Study group shown more effective results than placebo in pain relief (P`0.05). Based on the observations, it can be concluded that, fennel is an effective herbal drug for menstrual pain.
doi:10.4103/0974-8520.105259
PMCID: PMC3611645  PMID: 23559811
Fennel; Foeniculum vulgare; pain; primary dysmenorrhoea
4.  Morinda citrifolia (Noni) as an Anti-Inflammatory Treatment in Women with Primary Dysmenorrhoea: A Randomised Double-Blind Placebo-Controlled Trial 
Introduction. Noni (Morinda citrifolia) has been used for many years as an anti-inflammatory agent. We tested the efficacy of Noni in women with dysmenorrhea. Method. We did a prospective randomized double-blind placebo-controlled trial in 100 university students of 18 years and older over three menstrual cycles. Patients were invited to participate and randomly assigned to receive 400 mg Noni capsules or placebo. They were assessed for baseline demographic variables such as age, parity, and BMI. They were also assessed before and after treatment, for pain, menstrual blood loss, and laboratory variables: ESR, hemoglobin, and packed cell volume. Results. Of the 1027 women screened, 100 eligible women were randomized. Of the women completing the study, 42 women were randomized to Noni and 38 to placebo. There were no significant differences in any of the variables at randomization. There were also no significant differences in mean bleeding score or pain score at randomization. Both bleeding and pain scores gradually improved in both groups as the women were observed over three menstrual cycles; however, the improvement was not significantly different in the Noni group when compared to the controls. Conclusion. Noni did not show a reduction in menstrual pain or bleeding when compared to placebo.
doi:10.1155/2013/195454
PMCID: PMC3569913  PMID: 23431314
5.  Efficacy of ethinylestradiol 20 µg/drospirenone 3 mg in a flexible extended regimen in women with moderate-to-severe primary dysmenorrhoea: an open-label, multicentre, randomised, controlled study 
Objectives
The aim of this Phase III, multicentre, open-label, randomised study was to compare the efficacy and safety of ethinylestradiol (EE)/drospirenone (DRSP) in a new flexible extended regimen that allowed the management of intracyclic (breakthrough) bleeding (MIB) with that of EE/DRSP in a conventional 28-day regimen in women with moderate-to-severe primary dysmenorrhoea.
Methods
Women (aged 18–40 years) with moderate-to-severe primary dysmenorrhoea-related pain received a flexible extended regimen with MIB (flexibleMIB; minimum 24, maximum 120 days of continuous tablet intake for a flexible number of cycles to reach a treatment duration of at least 140 days with 4-day breaks between cycles) or a conventional 28-day regimen (24 active and four placebo tablets for five cycles) of EE/DRSP. The primary outcome was the number of days with dysmenorrhoeic pain over 140 days. Secondary outcomes included other dysmenorrhoea-related pain outcomes, bleeding profile, satisfaction and safety.
Results
Overall, 223 patients received study medication. There were significantly fewer days with dysmenorrhoeic pain with the flexibleMIB regimen than the conventional regimen (difference −4.2 days, 95% CI −6.5 to −2.0; p=0.0003), as well as considerably fewer days with at least moderate dysmenorrhoeic pain (difference −2.5 days, 95% CI −3.7 to −1.3), dysmenorrhoeic pain that interfered with daily activities (difference −2.2 days, 95% CI −4.2 to −0.1) and pelvic pain (difference −3.4 days, 95% CI −5.9 to −0.9). Adverse events were similar with both regimens.
Conclusions
Compared with the conventional regimen, the flexible extended regimen of EE/DRSP with MIB was associated with a significantly greater reduction in days with dysmenorrhoeic pain in women with moderate-to-severe primary dysmenorrhoea. The flexibleMIB regimen was also associated with greater improvements in dysmenorrhea according to the Clinical Global Impression rating scale and was generally well tolerated.
doi:10.1136/jfprhc-2011-100225
PMCID: PMC3353877  PMID: 22454006
6.  Pulsatile dry cupping in patients with osteoarthritis of the knee – a randomized controlled exploratory trial 
Introduction
Cupping is used in various traditional medicine forms to relieve pain in musculoskeletal diseases. The aim of this study was to investigate the effectiveness of cupping in relieving the symptoms of knee osteoarthritis (OA).
Methods
In a two-group, randomized controlled exploratory pilot study patients with a clinically and radiological confirmed knee OA (Kellgren-Lawrence Grading Scale: 2-4) and a pain intensity > 40 mm on a 100 mm visual analogue scale (VAS) were included. 40 Patients were randomized to either 8 sessions of pulsatile dry cupping within 4 weeks or no intervention (control). Paracetamol was allowed on demand for both groups. Outcomes were the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) score, the pain intensity on a VAS (0 mm = no pain to 100 mm = maximum intensity) and Quality of Life (SF-36) 4 and 12 weeks after randomization. Use of Paracetamol was documented within the 4-week treatment period. Analyses were performed by analysis of covariance adjusting for the baseline value for each outcome.
Results
21 patients were allocated to the cupping group (5 male; mean age 68 ± SD 7.2) and 19 to the control group (8 male; 69 ± 6.8). After 4 weeks the WOMAC global score improved significantly more in the cupping group with a mean of 27.7 (95% confidence interval 22.1; 33.3) compared to 42.2 (36.3; 48.1) in the control group (p = 0.001). After 12 weeks the WOMAC global score were still significantly different in favor for cupping (31.0 (24.9; 37.2) vs. 40.8 (34.4; 47.3) p = 0.032), however the WOMAC subscores for pain and stiffness were not significant anymore. Significantly better outcomes in the cupping group were also observed for pain intensity on VAS and for the SF-36 Physical Component Scale compared to the control group after 4 and 12 weeks. No significant difference was observed for the SF-36 Mental Component Scale and the total number of consumed Paracetamol tablets between both groups (mean 9.1, SD ± 20.0 vs. 11.5 ± 15.9).
Conclusion
In this exploratory study dry cupping with a pulsatile cupping device relieved symptoms of knee OA compared to no intervention. Further studies comparing cupping with active treatments are needed.
Trial registration
Clinicaltrials.gov Identifier: NCT01057043
doi:10.1186/1472-6882-12-184
PMCID: PMC3527288  PMID: 23057611
Cupping; Complementary and alternative medicine; Randomized controlled trial; Knee osteoarthritis
7.  PA03.08. A clinical study on the effect of yoga in Udavartini Vyapad w.s.r. to primary dysmenorrhoea 
Ancient Science of Life  2013;32(Suppl 2):S77.
Purpose:
1. To evaluate the role of yoga in the prevention of Udavarthini Yonivyapad 2. To observe other relative benefits after the intervention with yoga.?
Method:
It is a clinical study with a pretest and posttest design in three groups, each group comprising of 10 patients. Group A (medicine group) Group B (yoga group) Group C (yoga + medicine group) The yoga practice consisted of selected yogasanas, pranayama techniques and meditation with 2030 minutes duration for a period of 3 months with monthly assessment of improvement?.
Result:
Yoga practice has shown good results in reducing the intensity of pain by 38.24%. The other benefits observed with yoga practice were on regularizing the menstrual cycle by 43.75%. Associated symptoms of primary dysmenorrhoea got reduced by 57.14% and the premenstrual syndrome by 71.43%.?
Conclusion:
Pain was reduced markedly in yoga group when compaired to the medicine group and yoga+medicine group. The results are suggesting that efficacy in yoga group got increased in every follow up, indicating the need for continuous practice. Yoga practice regularizes the menstural cycle and also decreases the intensity of premenstural symptoms.?
doi:10.4103/0257-7941.123900
PMCID: PMC4147551
8.  The influence of a series of five dry cupping treatments on pain and mechanical thresholds in patients with chronic non-specific neck pain - a randomised controlled pilot study 
Background
In this preliminary trial we investigated the effects of dry cupping, an ancient method for treating pain syndromes, on patients with chronic non-specific neck pain. Sensory mechanical thresholds and the participants' self-reported outcome measures of pain and quality of life were evaluated.
Methods
Fifty patients (50.5 ± 11.9 years) were randomised to a treatment group (TG) or a waiting-list control group (WL). Patients in the TG received a series of 5 cupping treatments over a period of 2 weeks; the control group did not. Self-reported outcome measures before and after the cupping series included the following: Pain at rest (PR) and maximal pain related to movement (PM) on a 100-mm visual analogue scale (VAS), pain diary (PD) data on a 0-10 numeric rating scale (NRS), Neck Disability Index (NDI), and health-related quality of life (SF-36). In addition, the mechanical-detection thresholds (MDT), vibration-detection thresholds (VDT), and pressure-pain thresholds (PPT) were determined at pain-related and control areas.
Results
Patients of the TG had significantly less pain after cupping therapy than patients of the WL group (PR: Δ-22.5 mm, p = 0.00002; PM: Δ-17.8 mm, p = 0.01). Pain diaries (PD) revealed that neck pain decreased gradually in the TG patients and that pain reported by the two groups differed significantly after the fifth cupping session (Δ-1.1, p = 0.001). There were also significant differences in the SF-36 subscales for bodily pain (Δ13.8, p = 0.006) and vitality (Δ10.2, p = 0.006). Group differences in PPT were significant at pain-related and control areas (all p < 0.05), but were not significant for MDT or VDT.
Conclusions
A series of five dry cupping treatments appeared to be effective in relieving chronic non-specific neck pain. Not only subjective measures improved, but also mechanical pain sensitivity differed significantly between the two groups, suggesting that cupping has an influence on functional pain processing.
Trial registration
The trial was registered at clinicaltrials.gov (NCT01289964).
doi:10.1186/1472-6882-11-63
PMCID: PMC3224248  PMID: 21843336
9.  The Effect Dry Cupping Therapy at Acupoint BL23 on the Intensity of Postpartum Low Back Pain in Primiparous Women Based on Two Types of Questionnaires, 2012; A Randomized Clinical Trial 
Background: Continuous low back pain is associated with the symptoms of the pregnancy period. In spite of the improvement of low back pain within 6 months after the delivery, some women may develop chronic problems. This study aimed to investigate the effect of dry cupping therapy at BL23 point on the intensity of low back pain in primiparous women. 
Methods: In the present randomized clinical trial, 100 samples were randomly allocated to either the cupping therapy or the control group (each containing 50 subjects). Cupping therapy was performed for 15-20 minutes every day up to 4 consecutive times. Visual Analogue Scale (VAS) and short-form McGill pain questionnaire were completed by the two groups before the intervention and immediately, 24 hours, and 2 weeks after that. Then, the data were entered into the SPSS statistical software (v. 16) and analyzed using chi-square test and repeated measures ANOVA.
Results: According to VAS, the mean intensity of low back pain in the cupping therapy group decreased from 7.8±2.7 before the intervention to 3.7±1.8, 2.5±1.7, and 1.4±1.4 immediately, 24 hours, and 2 weeks after the intervention, respectively. Besides, these measures were respectively obtained as 31.8±10.8, 9.0±6.7, 7.5±6.6, and 3.6±4.1 in the short-form McGill pain questionnaire. According to repeated measures ANOVA, a significant difference was observed among the various stages of follow-up (P=0.01).
Conclusion: The study results showed cupping therapy to be effective in sedation of pain. Thus, it can be used as an effective treatment for reducing the low back pain.
Trial Registration Number: 2013072611944N3
PMCID: PMC4201191  PMID: 25349852
Dry Cupping; Acupuncture Point BL23; Low Back Pain; Postpartum
10.  Dysmenorrhoea 
Clinical Evidence  2007;2007:0813.
Introduction
Dysmenorrhoea may begin soon after the menarche, after which it often improves with age, or it may originate later in life after the onset of an underlying causative condition. Dysmenorrhoea is common, and in up to 20% of women it may be severe enough to interfere with daily activities.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for dysmenorrhoea? We searched: Medline, Embase, The Cochrane Library and other important databases up to July 2006 (BMJ Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 34 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupressure, acupuncture, aspirin, behavioural interventions, combined oral contraceptives, compound analgesics, fish oil, herbal remedies, magnesium, magnets, non-steroidal anti-inflammatory drugs, paracetamol, spinal manipulation, surgical interruption of pelvic nerve pathways, thiamine, toki-shakuyaku-san, topical heat, transcutaneous electrical nerve stimulation (TENS), vitamin B12, and vitamin E.
Key Points
Dysmenorrhoea may begin soon after the menarche, where it often improves with age, or may originate later in life after the onset of an underlying causative condition. Dysmenorrhoea is very common, and in up to 20% of women it may be severe enough to interfere with daily activities.Dysmenorrhoea is more likely in women who smoke, and those with an earlier age at menarche or longer duration of menstruation.
NSAIDs, reduce moderate to severe pain in women with primary dysmenorrhoea compared with placebo, but we don't know whether any one NSAID is superior to the others. Aspirin, paracetamol, and compound analgesics may reduce pain in the short term, although few studies have been of good quality.The herbal remedy toki-shakuyaku-san may reduce pain after 6 months compared with placebo, but we don't know whether any other herbal remedy is beneficial. Thiamine and vitamin E may reduce pain compared with placebo in women with primary dysmenorrhoea.
We don't know whether combined oral contraceptives reduce the pain of dysmenorrhoea, as studies have been small and have used products that are no longer available.
Topical heat (about 39 °C) may be as effective as ibuprofen and more effective than paracetamol at reducing pain. High frequency TENS may reduce pain compared with sham TENS, but seems to be less effective than ibuprofen. Acupressure may be more effective than sham acupressure at relieving dysmenorrhoea, and may be as effective as ibuprofen at relieving pain. Spinal manipulation seems to be no more effective than placebo at reducing pain after 1 month in women with primary dysmenorrhoea.We don't know whether acupuncture, relaxation or aerobic exercise, fish oil, magnesium, vitamin B12, surgical interruption of pelvic nerve pathways, or magnets reduce dysmenorrhoea, as few studies have been found.
PMCID: PMC2943779  PMID: 19454059
11.  Dysmenorrhoea 
Clinical Evidence  2011;2011:0813.
Introduction
Dysmenorrhoea may begin soon after the menarche, after which it often improves with age, or it may originate later in life after the onset of an underlying causative condition. Dysmenorrhoea is common, and in up to 20% of women it may be severe enough to interfere with daily activities.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for primary dysmenorrhoea? We searched: Medline, Embase, The Cochrane Library, and other important databases up to January 2010 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 35 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupressure, acupuncture, aspirin, behavioural interventions, contraceptives (combined oral), fish oil, herbal remedies, magnets, non-steroidal anti-inflammatory drugs, paracetamol, progestogens (intrauterine), spinal manipulation, surgical interruption of pelvic nerve pathways, thiamine, toki-shakuyaku-san, topical heat, transcutaneous electrical nerve stimulation (TENS), vitamin B12, and vitamin E.
Key Points
Dysmenorrhoea may begin soon after the menarche, where it often improves with age, or may originate later in life after the onset of an underlying causative condition. Dysmenorrhoea is very common, and in up to 20% of women it may be severe enough to interfere with daily activities.Dysmenorrhoea is more likely in women who smoke, and those with an earlier age at menarche or longer duration of menstruation.
NSAIDs reduce moderate to severe pain in women with primary dysmenorrhoea compared with placebo, but we don't know whether any one NSAID is superior to the others. Simple analgesics such as aspirin and paracetamol may reduce pain in the short term, although few studies have been of good quality.The herbal remedies toki-shakuyaku-san and Iranian herbal remedy (saffron, celery, and anise) may reduce pain compared with placebo. We don't know whether Chinese herbal remedies are beneficial compared with placebo, but we found limited evidence that they may be effective compared with other treatments for dysmenorrhoea. Thiamine and vitamin E may reduce pain compared with placebo in young women with primary dysmenorrhoea.
Combined oral contraceptives may be more effective at reducing pain in women with primary dysmenorrhoea compared with placebo; however, few trials have been of good quality.
Topical heat (about 39 °C) may be as effective as ibuprofen and more effective than paracetamol at reducing pain. High-frequency transcutaneous electrical nerve stimulation (TENS) may reduce pain compared with sham TENS, but seems to be less effective than ibuprofen. Acupressure may be more effective than sham acupressure or no treatment at relieving dysmenorrhoea. Spinal manipulation may be no more effective than placebo at reducing pain after 1 month in women with primary dysmenorrhoea. Relaxation may be better than no treatment at relieving dysmenorrhoea.We don't know whether acupuncture, fish oil, vitamin B12 , magnets, or intrauterine progestogens reduce dysmenorrhoea. Surgical interruption of pelvic nerve pathways is not beneficial in treating dysmenorrhoea, and may be associated with adverse effects including constipation.
PMCID: PMC3275141  PMID: 21718556
12.  Initiation rites at menarche and self-reported dysmenorrhoea among indigenous women of the Colombian Amazon: a cross-sectional study 
BMJ Open  2013;3(3):e002012.
Objectives
To investigate the association between self-reported dysmenorrhoea and patterns of female initiation rites at menarche among Amazonian indigenous peoples of Vaupés in Colombia.
Design
A cross-sectional study of all women in seven indigenous communities. Questionnaire administered in local language documented female initiation rites and experience of dysmenorrhoea. Analysis examined 10 initiation components separately, then together, comparing women who underwent all rites, some rites and no rites.
Settings
Seven indigenous communities belonging to the Tukano language group in the Great Eastern Reservation of Vaupés (Colombia) in 2008.
Participants
All women over the age of 13 years living in the seven communities in Vaupés, who had experienced at least two menstruations (n=185), aged 13–88 years (mean 32.5; SD 15.6).
Primary and secondary outcome measures
The analysis rested on pelvic pain to define dysmenorrhoea as the main outcome. Women were also asked about other disorders present during menstruation or the precedent days, and about the interval between two menstruations and duration of each one.
Results
Only 17.3% (32/185) completed all initiation rites and 52.4% (97/185) reported dysmenorrhoea. Women not completing the rites were more likely to report dysmenorrhoea than those who did so (p=0.01 Fisher exact), taking into account age, education, community, parity and use of family planning. Women who completed less than the full complement of rites had higher risk than those who completed all rites. Those who did not complete all rites reported increased severity of dysmenorrhoea (p=0.00014).
Conclusions
Our results are compatible with an association between traditional practices and women's health. We could exclude indirect associations with age, education, parity and use of family planning as explanations for the association. The study indicates feasibility, possible utility and limits of intercultural epidemiology in small groups.
doi:10.1136/bmjopen-2012-002012
PMCID: PMC3612793  PMID: 23457324
Intercultural ; Dysmenorrhoea; Tradicional medicine; Initiation rites
13.  Uterus didelphys with an obstructed unilateral vagina and ipsilateral renal agenesis: A rare cause of dysmenorrhoea 
Didelphic uterus with obstructed hemivagina and ipsilateral renal agenesis is a rare condition. It usually presents with pelvic pain following the menarche, dysmenorrhoea, and an increase in abdominal volume or a palpable mass due to unilateral haematocolpos. We present the case of a 13-year-old girl who referred with recurrent pelvic pain, mainly at the time of menses, and irregular menstrual cycle complaints in this report. The patient underwent ultrasonography and magnetic resonance (MR) imaging of the pelvis was performed. The diagnosis was uterus didelphys with obstructed hemivagina and ipsilateral renal agenesia. Laparotomy was performed for diagnosis and treatment purposes. Two separated hemiuteri and two cervices with hematometra and hematocolpos on the right side and ipsilateral renal agenesis were detected. The vaginal septum was excised completely and Strassman metroplasty was performed. Her complaints were resolved and she was absolutely asymptomatic after surgery. Diagnosis and management of this congenital anomaly is challenging due to the complexity of the anatomic structures, nonspecific complaints, and heterogenic presentation. These anomalies must always be considered while working-up female patients presenting with episodic abdominal pain and abdominopelvic mass.
doi:10.5152/jtgga.2013.44341
PMCID: PMC3935540  PMID: 24592115
Uterus didelphys; vaginoplasty; metroplasty; Müllerian anomalies; renal agenesis
14.  The experience of dysmenorrhoea among Ghanaian senior high and university students: pain characteristics and effects 
Reproductive Health  2014;11:58.
Background
Dysmenorrhoea is a common problem of women at the reproductive age and may have negative effect on the education of females at various stages on the educational ladder.
Context and purpose
This study sought to gain an in-depth understanding of the experience of dysmenorrhoea and its effect on female students in a secondary and a tertiary institution in Accra, Ghana.
Methods
The study employed a descriptive phenomenology design and was conducted at a University and a Senior High School (SHS) in Accra. Purposive and snowball sampling techniques were used to recruit participants and data was saturated with 16 participants. Concurrent analysis was done by applying the processes of content analysis and the NVivo software was used to manage the data.
Results
It was realized that dysmenorrhoea is associated with symptoms such as diarrhoea, headache and vomiting. Pain may start one week to the day of menstruation and the severity differed across the days of menstruation. The effect of dysmenorrhoea included activity intolerance, altered emotion and interaction, altered sleep pattern, absenteeism and inattentiveness, wishes and regrets, and misconceptions.
Conclusions
It was concluded that severe dysmenorrhoea has a debilitating effect on female students and is associated with misconceptions that could result in drastic action with fatal consequences. Thus, there is the need to enhance education on dysmenorrhoea, and an aggressive step should be taken to effectively manage dysmenorrhoea.
doi:10.1186/1742-4755-11-58
PMCID: PMC4113597  PMID: 25064081
Qualitative research; Phenomenology; Ghana; Menstrual pain; Adolescents
15.  Rofecoxib for dysmenorrhoea: meta-analysis using individual patient data 
BMC Women's Health  2004;4:5.
Background
Individual patient meta-analysis to determine the analgesic efficacy and adverse effects of single-dose rofecoxib in primary dysmenorrhoea.
Methods
Individual patient information was available from three randomised, double blind, placebo and active controlled trials of rofecoxib. Data were combined through meta-analysis. Number-needed-to-treat (NNT) for at least 50% pain relief and the proportion of patients who had taken rescue medication over 12 hours were calculated. Information was collected on adverse effects.
Results
For single-dose rofecoxib 50 mg compared with placebo, the NNTs (with 95% CI) for at least 50% pain relief were 3.2 (2.4 to 4.5) at six, 3.1 (2.4 to 9.0) at eight, and 3.7 (2.8 to 5.6) at 12 hours. For naproxen sodium 550 mg they were 3.1 (2.4 to 4.4) at six, 3.0 (2.3 to 4.2) at eight, and 3.8 (2.7 to 6.1) at 12 hours. The proportion of patients who needed rescue medication within 12 hours was 27% with rofecoxib 50 mg, 29% with naproxen sodium 550 mg, and 50% with placebo. In the single-dose trial, the proportion of patients reporting any adverse effect was 8% (4/49) with rofecoxib 50 mg, 12% (6/49) with ibuprofen 400 mg, and 6% (3/49) with placebo. In the other two multiple dose trials, the proportion of patients reporting any adverse effect was 23% (42/179) with rofecoxib 50 mg, 24% (45/181) with naproxen sodium 550 mg, and 18% (33/178) with placebo.
Conclusions
Single dose rofecoxib 50 mg provided similar pain relief to naproxen sodium 550 mg over 12 hours. The duration of analgesia with rofecoxib 50 mg was similar to that of naproxen sodium 550 mg. Adverse effects were uncommon suggesting safety in short-term use of rofecoxib and naproxen sodium. Future research should include restriction on daily life and absence from work or school as outcomes.
doi:10.1186/1472-6874-4-5
PMCID: PMC493273  PMID: 15265230
16.  Prevalence and Impact of Dysmenorrhoea among Omani High School Students 
Objectives:
The objectives of this study were to determine the prevalence of dysmenorrhoea in Omani high schoolgirls, its impact and the treatment used.
Methods:
A cross-sectional survey was carried out in May 2010 on 404 girls from two public high schools in the Muscat region. Data were collected by self-administered questionnaire including information on demographics, prevalence of dysmenorrhoea, severity, its impact, and the treatment used.
Results:
Overall, 94% (n = 380) of the participants had dysmenorrhoea. It was mild in 27% (n = 104), moderate in 41% (n = 155), and severe in 32% (n = 121). Dysmenorrhoea was the cause of limited sports activities in 81%, decreased class concentration in 75%, restricted homework in 59%, school absenteeism in 45%, limited social activities in 25%, and decreased academic performance in 8% of the affected students. Only 3% (n = 10) had consulted a physician; 21% (n = 80) self-medicated, and 55% (n = 210) took no action. The commonest drugs used were paracetamol (n = 60, 16%), ibuprofen (n = 29, 8%) and mefenemic acid (n = 12, 3%). There was no statistically significant correlation between dysmenorrhoea, demographics and menstrual characteristics.
Conclusion:
Dysmenorrhoea is a prevalent and yet undertreated menstrual disorder among Omani adolescent schoolgirls. The pain suffered can be severe and disabling. Doctors should therefore be prepared to discuss this more freely with schoolgirls. In addition, there is a need for education regarding dysmenorrhoea and treatment options to minimise the impact on school, sports, social and daily activities.
PMCID: PMC3206751  PMID: 22087397
Dysmenorrhoea; Painful menstruation; Prevalence; Impact; Adolescent girls; High school; Students; Oman
17.  Effectiveness of Home-Based Cupping Massage Compared to Progressive Muscle Relaxation in Patients with Chronic Neck Pain—A Randomized Controlled Trial 
PLoS ONE  2013;8(6):e65378.
Chronic neck pain is a major public health problem with very few evidence-based complementary treatment options. This study aimed to test the efficacy of 12 weeks of a partner-delivered home-based cupping massage, compared to the same period of progressive muscle relaxation in patients with chronic non-specific neck pain. Patients were randomly assigned to self-directed cupping massage or progressive muscle relaxation. They were trained and asked to undertake the assigned treatment twice weekly for 12 weeks. Primary outcome measure was the current neck pain intensity (0–100 mm visual analog scale; VAS) after 12 weeks. Secondary outcome measures included pain on motion, affective pain perception, functional disability, psychological distress, wellbeing, health-related quality of life, pressure pain thresholds and adverse events. Sixty one patients (54.1±12.7 years; 73.8%female) were randomized to cupping massage (n = 30) or progressive muscle relaxation (n = 31). After treatment, both groups showed significantly less pain compared to baseline however without significant group differences. Significant effects in favor of cupping massage were only found for wellbeing and pressure pain thresholds. In conclusion, cupping massage is no more effective than progressive muscle relaxation in reducing chronic non-specific neck pain. Both therapies can be easily used at home and can reduce pain to a minimal clinically relevant extent. Cupping massage may however be better than PMR in improving well-being and decreasing pressure pain sensitivity but more studies with larger samples and longer follow-up periods are needed to confirm these results.
Trial Registration
ClinicalTrials.gov NCT01500330
doi:10.1371/journal.pone.0065378
PMCID: PMC3676414  PMID: 23762355
18.  Animal Study on Primary Dysmenorrhoea Treatment at Different Administration Times 
The new methods of different administration times for the treatment of primary dysmenorrhea are more widely used clinically; however, no obvious mechanism has been reported. Therefore, an animal model which is closer to clinical evaluation is indispensable. A novel animal experiment with different administration times, based on the mice oestrous cycle, for primary dysmenorrhoea treatment was explored in this study. Mice were randomly divided into two parts (one-cycle and three-cycle part) and each part includes five groups (12 mice per group), namely, Jingqian Zhitong Fang (JQF) 6-day group, JQF last 3-day group, Yuanhu Zhitong tablet group, model control group, and normal control group. According to the one-way ANOVAs, results (writhing reaction, and PGF2α, PGE2, NO, and calcium ions analysis by ELISA) of the JQF cycle group were in accordance with those of JQF last 3-day group. Similarly, results of three-cycle continuous administration were consistent with those of one-cycle treatment. In conclusion, the consistency of the experimental results illustrated that the novel animal model based on mice oestrous cycle with different administration times is more reasonable and feasible and can be used to explore in-depth mechanism of drugs for the treatment of primary dysmenorrhoea in future.
doi:10.1155/2015/367379
PMCID: PMC4332465
19.  Effect of Medicinal Herbs on Primary Dysmenorrhoea- a Systematic Review  
Conventional treatment for primary dysmenorrhoea has a failure rate of 20% to 25% and may be contraindicated or not tolerated by some women. Herbal medicine may be a suitable alternative. To determine the efficacy and safety of Iranian herbal medicine for primary dysmenorrhea when compared with placebo, no treatment, and other treatment.
Electronic searches of the Cochrane Menstrual Disorders and Dysmenorrhoea Group Register of controlled trials, Scopus, Google Scholar, Medline, Pubmed were performed to identify relevant randomized controlled trials (RCTs).
The study abstraction and quality assessment of all studies were undertaken following the detailed descriptions of these categories as described in the JADAD Criteria for Systematic Reviews of Interventions.
25 RCTs involving a total of women were included in the review. The review found promising evidence in the form of RCTs for the use of herbal medicine in the treatment of primary dysmenorrhoea compared with pharmacological treatment. However, the results were limited by methodological flaws. Further rigorous no penetrating placebo-controlled RCTs are warranted.
The review found promising evidence supporting the use of herbal medicine for primary dysmenorrhoea; however, results are limited by the poor methodological quality of the included trials.
PMCID: PMC4177637  PMID: 25276177
Primary dysmenorrhea; Herbal medicine; JADAD Criteria; Randomized controlled trials
20.  Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial 
Trials  2011;12:146.
Background
Persistent non-specific low back pain (PNSLBP) is one of the most frequently experienced types of back pain around the world. Wet-cupping is a common intervention for various pain conditions, especially in Korea. In this context, we conducted a pilot study to determine the effectiveness and safety of wet-cupping treatment for PNSLBP.
Methods
We recruited 32 participants (21 in the wet-cupping group and 11 in the waiting-list group) who had been having PNSLBP for at least 3 months. The participants were recruited at the clinical research centre of the Korea Institute of Oriental Medicine, Korea. Eligible participants were randomly allocated to wet-cupping and waiting-list groups. Following the practice of traditional Korean medicine, the treatment group was provided with wet-cupping treatment at two acupuncture points among the BL23, BL24 and BL25 6 times within 2 weeks. Usual care, including providing brochures for exercise, general advice for PNSLBP and acetaminophen, was allowed in both groups. Separate assessors participated in the outcome assessment. We used the 0 to100 numerical rating scale (NRS) for pain, the McGill Pain Questionnaire for pain intensity (PPI) and the Oswestry Disability Questionnaire (ODQ), and we assessed acetaminophen use and safety issues.
Results
The results showed that the NRS score for pain decreased (-16.0 [95% CI: -24.4 to -7.7] in the wet-cupping group and -9.1 [-18.1 to -0.1] in the waiting-list group), but there was no statistical difference between the groups (p = 0.52). However, the PPI scores showed significant differences between the two groups (-1.2 [-1.6 to -0.8] for the wet-cupping group and -0.2 [-0.8 to 0.4] for the waiting-list group, p < 0.01). In addition, less acetaminophen was used in the wet-cupping group during 4 weeks (p = 0.09). The ODQ score did not show significant differences between the two groups (-5.60 [-8.90 to -2.30] in the wet-cupping group and -1.8 [-5.8 to 2.2] in the waiting-list group, p = 0.14). There was no report of adverse events due to wet-cupping.
Conclusion
This pilot study may provide preliminary data on the effectiveness and safety of wet-cupping treatments for PNSLBP. Future full-scale randomised controlled trials will be needed to provide firm evidence of the effectiveness of this intervention.
Trial Registration
ClinicalTrials.gov: (Identifier: NCT00925951)
Date of trial registration: June 19th, 2009
The date when the first patient was randomised: July 15th, 2009
The date when the study was completed: November 27th, 2009
doi:10.1186/1745-6215-12-146
PMCID: PMC3141528  PMID: 21663617
21.  Transdermal Fentanyl Patches Versus Patient-Controlled Intravenous Morphine Analgesia for Postoperative Pain Management 
Background:
Acute and severe pain is common in patients postoperatively and should be correctly managed. In the past years studies on preparing better postoperative pain control have resulted in development of postoperative pain management guidelines. Perhaps, one of the major improvements in managing postoperative pain is the development of the patient-controlled analgesia systems (PCA), especially through intra venous (IV), extradural and transdermal routes, which has resulted in marked improvements in acute postoperative pain management. Physicians administrate potent opioids for moderate to severe post-surgical pains. Morphine is the most commonly IV-PCA administrated analgesic. The fentanyl iontophoretic transdermal system (fentanyl ITS) is also another efficient option for pain management.
Objectives:
The aim of this study was to compare the analgesic effects of these two routine postoperative pain control systems.
Patients and Methods:
We enrolled 281 patients (224 males, 57 females) in this blind randomized controlled clinical trial, who had undergone an orthopedic surgery, with the mean age of 33.91 ± 14.45 years. Patients were randomly divided into two groups; in group A patients received IV-morphine PCA pump and in group B fentanyl transdermal patches were attached on patients’ arms. The severity of the pain was registered according to Visual Analogue Scale in specially designed forms by pain-trained nurses in two steps; first after the surgery and next before the beginning of analgesic effects. After 24 hours, the pain score was assessed again.
Results:
No significant difference was observed in mean pain intensity score at the first patient assessment. Mean pain intensity scores were also similar in both groups at the last measured time point (P > 0.05). Differential pain intensity scores, showing the impacts of analgesic system on the pain experience of the patients was also similar between fentanyl patches (6.48 ± 2.20) and morphine PCIA (6.40 ± 1.80). (P > 0.05) Mean patient satisfactory score (scale: 0–100) was also similar in both groups (P > 0.05). The percentage of patients, whose differential pain intensity scores at 24 hours reached our pain management goal was similar between fentanyl and morphine groups (P > 0.05). The percentage of patients with at least one adverse event was significantly higher in fentanyl group (P < 0.05). The most frequent adverse events were nausea, vomiting and itching. In none of the groups, no patient experienced serious adverse events related to the studied medications.
Conclusions:
Although both pain killing therapeutic regimens are safe and effective for postoperative pain management, regarding the easy usage of the patches, lower risk of abuse and cost-effectiveness in the Iranian market, it is recommended for use in Iranian hospitals and trauma centers and in countries with similar socioeconomic situations.
doi:10.5812/ircmj.11502
PMCID: PMC4082507  PMID: 25031847
Fentanyl; Morphine; Analgesia; Patients; Pain Management; Postoperative Period
22.  A Novel Tool for the Assessment of Pain: Validation in Low Back Pain 
PLoS Medicine  2009;6(4):e1000047.
Joachim Scholz and colleagues develop and validate an assessment tool that distinguishes between radicular and axial low back pain.
Background
Adequate pain assessment is critical for evaluating the efficacy of analgesic treatment in clinical practice and during the development of new therapies. Yet the currently used scores of global pain intensity fail to reflect the diversity of pain manifestations and the complexity of underlying biological mechanisms. We have developed a tool for a standardized assessment of pain-related symptoms and signs that differentiates pain phenotypes independent of etiology.
Methods and Findings
Using a structured interview (16 questions) and a standardized bedside examination (23 tests), we prospectively assessed symptoms and signs in 130 patients with peripheral neuropathic pain caused by diabetic polyneuropathy, postherpetic neuralgia, or radicular low back pain (LBP), and in 57 patients with non-neuropathic (axial) LBP. A hierarchical cluster analysis revealed distinct association patterns of symptoms and signs (pain subtypes) that characterized six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain. Using a classification tree analysis, we identified the most discriminatory assessment items for the identification of pain subtypes. We combined these six interview questions and ten physical tests in a pain assessment tool that we named Standardized Evaluation of Pain (StEP). We validated StEP for the distinction between radicular and axial LBP in an independent group of 137 patients. StEP identified patients with radicular pain with high sensitivity (92%; 95% confidence interval [CI] 83%–97%) and specificity (97%; 95% CI 89%–100%). The diagnostic accuracy of StEP exceeded that of a dedicated screening tool for neuropathic pain and spinal magnetic resonance imaging. In addition, we were able to reproduce subtypes of radicular and axial LBP, underscoring the utility of StEP for discerning distinct constellations of symptoms and signs.
Conclusions
We present a novel method of identifying pain subtypes that we believe reflect underlying pain mechanisms. We demonstrate that this new approach to pain assessment helps separate radicular from axial back pain. Beyond diagnostic utility, a standardized differentiation of pain subtypes that is independent of disease etiology may offer a unique opportunity to improve targeted analgesic treatment.
Editors' Summary
Background
Pain, although unpleasant, is essential for survival. Whenever the body is damaged, nerve cells detecting the injury send an electrical message via the spinal cord to the brain and, as a result, action is taken to prevent further damage. Usually pain is short-lived, but sometimes it continues for weeks, months, or years. Long-lasting (chronic) pain can be caused by an ongoing, often inflammatory condition (for example, arthritis) or by damage to the nervous system itself—experts call this “neuropathic” pain. Damage to the brain or spinal cord causes central neuropathic pain; damage to the nerves that convey information from distant parts of the body to the spinal cord causes peripheral neuropathic pain. One example of peripheral neuropathic pain is “radicular” low back pain (also called sciatica). This is pain that radiates from the back into the legs. By contrast, axial back pain (the most common type of low back pain) is confined to the lower back and is non-neuropathic.
Why Was This Study Done?
Chronic pain is very common—nearly 10% of American adults have frequent back pain, for example—and there are many treatments for it, including rest, regulated exercise (physical therapy), pain-killing drugs (analgesics), and surgery. However, the best treatment for any individual depends on the exact nature of their pain, so it is important to assess their pain carefully before starting treatment. This is usually done by scoring overall pain intensity, but this assessment does not reflect the characteristics of the pain (for example, whether it occurs spontaneously or in response to external stimuli) or the complex biological processes involved in pain generation. An assessment designed to take such factors into account might improve treatment outcomes and could be useful in the development of new therapies. In this study, the researchers develop and test a new, standardized tool for the assessment of chronic pain that, by examining many symptoms and signs, aims to distinguish between pain subtypes.
What Did the Researchers Do and Find?
One hundred thirty patients with several types of peripheral neuropathic pain and 57 patients with non-neuropathic (axial) low back pain completed a structured interview of 16 questions and a standardized bedside examination of 23 tests. Patients were asked, for example, to choose words that described their pain from a list provided by the researchers and to grade the intensity of particular aspects of their pain from zero (no pain) to ten (the maximum imaginable pain). Bedside tests included measurements of responses to light touch, pinprick, and vibration—chronic pain often alters responses to harmless stimuli. Using “hierarchical cluster analysis,” the researchers identified six subgroups of patients with neuropathic pain and two subgroups of patients with non-neuropathic pain based on the patterns of symptoms and signs revealed by the interviews and physical tests. They then used “classification tree analysis” to identify the six questions and ten physical tests that discriminated best between pain subtypes and combined these items into a tool for a Standardized Evaluation of Pain (StEP). Finally, the researchers asked whether StEP, which took 10–15 minutes, could identify patients with radicular back pain and discriminate them from those with axial back pain in an independent group of 137 patients with chronic low back pain. StEP, they report, accurately diagnosed these two conditions and was well accepted by the patients.
What Do These Findings Mean?
These findings indicate that a standardized assessment of pain-related signs and symptoms can provide a simple, quick diagnostic procedure that distinguishes between radicular (neuropathic) and axial (non-neuropathic) low back pain. This distinction is crucial because these types of back pain are best treated in different ways. In addition, the findings suggest that it might be possible to identify additional pain subtypes using StEP. Because these subtypes may represent conditions in which different pain mechanisms are acting, classifying patients in this way might eventually enable physicians to tailor treatments for chronic pain to the specific needs of individual patients rather than, as at present, largely guessing which of the available treatments is likely to work best.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000047.
This study is further discussed in a PLoS Medicine Perspective by Giorgio Cruccu and and Andrea Truini
The US National Institute of Neurological Disorders and Stroke provides a primer on pain in English and Spanish
In its 2006 report on the health status of the US, the National Center for Health Statistics provides a special feature on the epidemiology of pain, including back pain
The Pain Treatment Topics Web site is a resource, sponsored partly by associations and manufacturers, that provides information on all aspects of pain and its treatment for health care professionals and their patients
Medline Plus provides a brief description of pain and of back pain and links to further information on both topics (in English and Spanish)
The MedlinePlus Medical Encyclopedia also has a page on low back pain (in English and Spanish)
doi:10.1371/journal.pmed.1000047
PMCID: PMC2661253  PMID: 19360087
23.  Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials 
BMJ : British Medical Journal  2004;329(7478):1317.
Objective To estimate the analgesic efficacy of non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclo-oxygenase-2 inhibitors (coxibs), in patients with osteoarthritis of the knee.
Design Systematic review and meta-analysis of randomised placebo controlled trials.
Studies reviewed 23 trials including 10 845 patients, median age of 62.5 years. 7807 patients received adequate doses of NSAIDs and 3038 received placebo. The mean weighted baseline pain score was 64.2 mm on 100 mm visual analogue scale (VAS), and average duration of symptoms was 8.2 years.
Main outcome measure Change in overall intensity of pain.
Results Methodological quality of trials was acceptable, but 13 trials excluded patients before randomisation if they did not respond to NSAIDs. One trial provided long term data for pain that showed no significant effect of NSAIDs compared with placebo at one to four years. The pooled difference for pain on visual analogue scale in all included trials was 10.1 mm (95% confidence interval 7.4 to 12.8) or 15.6% better than placebo after 2-13 weeks. The results were heterogeneous, and the effect size for pain reduction was 0.32 (0.24 to 0.39) in a random effects model. In 10 trials that did not exclude non-responders to NSAID treatment the results were homogeneous, with an effect size for pain reduction of 0.23 (0.15 to 0.31).
Conclusion NSAIDs can reduce short term pain in osteoarthritis of the knee slightly better than placebo, but the current analysis does not support long term use of NSAIDs for this condition. As serious adverse effects are associated with oral NSAIDs, only limited use can be recommended.
doi:10.1136/bmj.38273.626655.63
PMCID: PMC534841  PMID: 15561731
24.  Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain 
OBJECTIVE:
The present randomized, double-blinded, crossover study compared the efficacy and safety of a seven-day buprenorphine transdermal system (BTDS) and placebo in patients with low back pain of moderate or greater severity for at least six weeks.
METHODS:
Prestudy analgesics were discontinued the evening before random assignment to 5 μg/h BTDS or placebo, with acetaminophen 300 mg/codeine 30 mg, one to two tablets every 4 h to 6 h as needed, for rescue analgesia. The dose was titrated to effect weekly, if tolerated, to 10 μg/h and 20 μg/h BTDS. Each treatment phase was four weeks.
RESULTS:
Fifty-three patients (28 men, 25 women, mean [± SD] age 54.5±12.7 years) were evaluable for efficacy (completed two weeks or more in each phase). Baseline pain was 62.1±15.5 mm (100 mm visual analogue scale) and 2.5±0.6 (five-point ordinal scale). BTDS resulted in lower mean daily pain scores than in the placebo group (37.6±20.7 mm versus 43.6±21.2 mm on a visual analogue scale, P=0.0487; and 1.7±0.6 versus 2.0±0.7 on the ordinal scale, P=0.0358). Most patients titrated to the highest dose of BTDS (59% 20 μg/h, 31% 10 μg/h and 10% 5 μg/h). There were improvements from baseline in pain and disability (Pain Disability Index), Pain and Sleep (visual analogue scale), Quebec Back Pain Disability Scale and Short-Form 36 Health Survey scores for both BTDS and placebo groups, without significant differences between treatments. While there were more opioid-related side effects with BTDS treatment than with placebo, there were no serious adverse events. A total of 82% of patients chose to continue BTDS in a long-term open-label evaluation, in whom improvements in pain intensity, functionality and quality of life were sustained for up to six months without analgesic tolerance.
CONCLUSION:
BTDS (5 μg/h to 20 μg/h) represents a new treatment option for initial opioid therapy in patients with chronic low back pain.
PMCID: PMC2912613  PMID: 20577660
Buprenorphine; Low back pain; Transdermal system
25.  Assessing pain intensity in children with chronic pain: Convergent and discriminant validity of the 0 to 10 numerical rating scale in clinical practice 
Assessment of children’s self-reported pain is essential for pain management, and must be conducted using a measure that is simple, valid and easy to administer. The numerical analogue scale, on which individuals rate their pain on a scale of 0 to 10, is validated and widely used in adults experiencing both acute and chronic pain. The scale is also often used in children and is believed to be an appropriate tool, although this has not been formally assessed among children experiencing chronic pain. Accordingly, the authors of this article conducted a retrospective analysis of the numerical rating scale using data obtained during assessment at a pediatric chronic pain clinic in Toronto, Ontario
BACKGROUND:
In clinical practice, children are often asked to rate their pain intensity on a simple 0 to 10 numerical rating scale (NRS). Although the NRS is a well-established measure for adults, no study has yet evaluated its validity for children with chronic pain.
OBJECTIVES:
To examine the convergent and discriminant validity of the NRS as it is used within regular clinical practice to document pain intensity for children with chronic pain. Interchangeability between the NRS and an analogue pain measure was also assessed.
METHODS:
A cohort of 143 children (mean [± SD] age 14.1±2.4 years; 72% female) rated their pain intensity (current, usual, lowest and strongest levels) on a verbally administered 0 to 10 NRS during their first appointment at a specialized pain clinic. In a separate session that occurred either immediately before or after their appointment, children also rated their pain using the validated 0 to 10 coloured analogue scale (CAS).
RESULTS:
NRS ratings met a priori criteria for convergent validity (r>0.3 to 0.5), correlating with CAS ratings at all four pain levels (r=0.58 to 0.68; all P<0.001). NRS for usual pain intensity differed significantly from an affective pain rating, as hypothesized (Z=2.84; P=0.005), demonstrating discriminant validity. The absolute differences between NRS and CAS pain scores were small (range 0.98±1.4 to 1.75±1.9); however, the two scales were not interchangeable.
CONCLUSIONS:
The present study provides preliminary evidence that the NRS is a valid measure for assessing pain intensity in children with chronic pain.
PMCID: PMC4158959  PMID: 24712019
Children; Chronic pain; Clinical pain assessment; Numerical rating scale; Pain intensity scales

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