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1.  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.
PMCID: PMC3611645  PMID: 23559811
Fennel; Foeniculum vulgare; pain; primary dysmenorrhoea
2.  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 
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.
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.
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.
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.
PMCID: PMC3353877  PMID: 22454006
3.  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.
PMCID: PMC3569913  PMID: 23431314
4.  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.
PMCID: PMC3935540  PMID: 24592115
Uterus didelphys; vaginoplasty; metroplasty; Müllerian anomalies; renal agenesis
5.  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 
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.
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.
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.
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 (NCT01289964).
PMCID: PMC3224248  PMID: 21843336
6.  Pulsatile dry cupping in patients with osteoarthritis of the knee – a randomized controlled exploratory trial 
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).
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.
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).
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 Identifier: NCT01057043
PMCID: PMC3527288  PMID: 23057611
Cupping; Complementary and alternative medicine; Randomized controlled trial; Knee osteoarthritis
7.  The effect of aquatic exercises on primary dysmenorrhoea in nonathlete girls 
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.
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).
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
8.  Rofecoxib for dysmenorrhoea: meta-analysis using individual patient data 
BMC Women's Health  2004;4:5.
Individual patient meta-analysis to determine the analgesic efficacy and adverse effects of single-dose rofecoxib in primary dysmenorrhoea.
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.
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.
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.
PMCID: PMC493273  PMID: 15265230
9.  Stress and dysmenorrhoea: a population based prospective study 
Background: Dysmenorrhoea is the most common gynaecological disorder in women of reproductive age. Despite the association between stress and pregnancy outcomes, few studies have examined the possible link between stress and dysmenorrhoea.
Aims and Methods: Using a population based cohort of Chinese women, the independent effect of women's perceived stress in the preceding menstrual cycle on the incidence of dysmenorrhoea in the subsequent cycle was investigated prospectively. The analysis included 1160 prospectively observed menstrual cycles from 388 healthy, nulliparous, newly married women who intended to conceive. The perception of stress and the occurrence of dysmenorrhoea in each menstrual cycle were determined from daily diaries recorded by the women.
Results: After adjustment for important covariates, the risk of dysmenorrhoea was more than twice as great among women with high stress compared to those with low stress in the preceding cycle (OR = 2.4; 95% CI 1.4 to 4.3). The risk of dysmenorrhoea was greatest among women with both high stress and a history of dysmenorrhoea compared to women with low stress and no history of dysmenorrhoea (OR = 10.4, 95% CI 4.9 to 22.3). Stress in the follicular phase of the preceding cycles had a stronger association with dysmenorrhoea than stress in the luteal phase of the preceding cycles.
Conclusion: This study shows a significant association between stress and the incidence of dysmenorrhoea, which is even stronger among women with a history of dysmenorrhoea.
PMCID: PMC1740691  PMID: 15550609
10.  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.
To investigate the association between self-reported dysmenorrhoea and patterns of female initiation rites at menarche among Amazonian indigenous peoples of Vaupés in Colombia.
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.
Seven indigenous communities belonging to the Tukano language group in the Great Eastern Reservation of Vaupés (Colombia) in 2008.
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.
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).
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.
PMCID: PMC3612793  PMID: 23457324
Intercultural ; Dysmenorrhoea; Tradicional medicine; Initiation rites
11.  Investigatingthe Effect of Pressure on Third Liver Point on Primary Dysmenorrhea: a Randomized Controlled Clinical Trial 
Primary dysmenorrhea (PD) is a term used to describe uterine muscle spasms which occurs during the days of menstruation.
To determine the effect of acupressure on third liver point on primary dysmenorrhea.
Patients and Methods
Female students living in dormitories of Kashan University of Medical Sciences in Iran who had PD were studied for three menstrual cycles between March till June 2012. Individuals with depression score higher than 19 according to the Beck-21 Depression scale were excluded. In the first cycle, pain intensity was assessed without intervention, and 67 samples with a pain score greater than 4 according to the visual analogue scale (VAS) were selected. Then they were randomized into third liver point (liv3) and control (placebo) groups using randomized block design with 1:1 allocation ratio based on pain intensity. In the second and third cycles, pressure was applied by the research unit intermittently for 16 minutes (2 minutes pressure, 2 minutes resting) with the starting of blood flow. Primary outcome of this study was the pain intensity which was compared between first and third cycles. Someone who divided groups, samples and data analyzer was blinded.
In the treatment group 27 samples and in the control group 32 samples were analyzed. Friedman test showed significant differences in pain intensity before and after the intervention within both groups (P < 0.05). There were no significant differences between the groups according to the ordinal regression test in 3 cycles (P > 0.05).
The pressure on the LIV3 applied in this investigation was effective in reducing primary dysmenorrheal pain. So using this method is recommended to reduce PD.
PMCID: PMC3929823  PMID: 24616798
Acupressure; Dysmenorrhea; Liver
12.  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 NCT01500330
PMCID: PMC3676414  PMID: 23762355
13.  A Randomised Placebo-Controlled Trial of a Traditional Chinese Herbal Formula in the Treatment of Primary Dysmenorrhoea 
PLoS ONE  2007;2(8):e719.
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.
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 ISRCTN23374750
PMCID: PMC1940310  PMID: 17710126
14.  Evaluation of the Effect of Laser Acupuncture and Cupping with Ryodoraku and Visual Analog Scale on Low Back Pain 
The purpose of this study was to evaluate the effect of laser acupuncture (LA) and soft cupping on low back pain. In this study, the subjects were randomly assigned to two groups: active group (real LA and soft cupping) and placebo group (sham laser and soft cupping). Visual analog scale (VAS) and Ryodoraku were used to evaluate the effect of treatment on low back pain in this trial. Laser, 40 mW, wavelength 808 nm, pulse rate 20 Hz, was used to irradiate Weizhong (BL40) and Ashi acupoints for 10 minutes. And the Ryodoraku values were measured 2 times, that is, before and 15 minutes after treatment. The results show that there were significant difference between the first day baseline and the fifth day treatment in VAS in the two groups. Therefore, LA combined with soft cupping or only soft cupping was effective on low back pain. However, the Ryodoraku values of Bladder Meridian of the placebo group have been decreased apparently, and didn't come back to their original values. It means that “cupping” plays the role of “leak or purge” in traditional Chinese medicine (TCM). On the other hand, the Ryodoraku values of Bladder Meridian of the active group have been turned back to almost their original values; “mend or reinforcing” effect is attributed to the laser radiation.
PMCID: PMC3482015  PMID: 23118792
15.  Coffee intake and development of pain during computer work 
BMC Research Notes  2012;5:480.
The present study sought to determine if subjects who had consumed coffee before performing a simulated computer office-work task found to provoke pain in the neck and shoulders and forearms and wrists exhibited different time course in the pain development than the subjects who had abstained from coffee intake.
Forty eight subjects all working fulltime, 22 with chronic shoulder and neck pain and 26 healthy pain-free subjects, were recruited to perform a computer-based office-work task for 90 min. Nineteen (40%) of the subjects had consumed coffee (1/2 -1 cup) on average 1 h 18 min before start. Pain intensity in the shoulders and neck and forearms and wrists was rated on a visual analogue scale every 15 min throughout the work task.
During the work task the coffee consumers exhibited significantly lower pain increase than those who abstained from coffee.
Subjects who had consumed coffee before starting a pain provoking office work task exhibited attenuated pain development compared with the subjects who had abstained from coffee intake. These results might have potentially interesting implications of a pain-modulating effect of caffeine in an everyday setting. However, studies with a double blind placebo controlled randomized design are needed.
PMCID: PMC3476989  PMID: 22943590
Computer work; Muscle; Pain; Coffee
16.  Treatment of Burning Mouth Syndrome With Amisulpride 
Burning mouth syndrome (BMS) is a frequently occurring disease characterized by a burning or painful sensation in the tongue and/or other oral sites without clinical mucosal abnormalities or lesions. Its etiopathology is unknown, although local, systemic, and psychological factors have been associated with BMS. The syndrome is multifactorial, and its management remains unsatisfactory. The purpose of this study was to obtain preliminary data regarding the efficacy and tolerability of amisulpride in BMS treatment.
The subjects were treated with amisulpride (50 mg/day) for 24 weeks. Efficacy assessment included a visual analogue scale (VAS) for pain intensity, the Hamilton Rating Scale for Depression (HAM-D), the Hamilton Rating Scale for Anxiety (HASM-A), and the Clinical Global Impression Scale-Efficacy Index (CGI-EI).
The treatment regimens resulted in a significant improvement in burning mouth symptoms from baseline at week 24, as indicated by the quantitative mean illness duration VAS score, HAM-D, and HAM-A. Amisulpride appears to be effective and patients show a rapid response to treatment. No serious adverse effects were encountered in these patients.
Amisulpride is effective and well tolerated as a short-term treatment. It is particularly efficacious at the start of treatment and has shorter response latency. Double-blind placebo-controlled trials are needed for further assessment of the efficacy of amisulpride in BMS treatment.
PMCID: PMC3376874  PMID: 22719802
Burning mouth syndrome; Amisulpride; Women
17.  Impact of PCA Strategies on Pain Intensity and Functional Assessment Measures in Adults with Sickle Cell Disease during Hospitalized Vaso-Occlusive Episodes 
American journal of hematology  2012;87(10):E71-E74.
Clinical trials of sickle cell disease (SCD) pain treatment usually observe only small decrements in pain intensity during the course of hospitalization. Sub-optimal analgesic management and inadequate pain assessment methods are possible explanations for these findings. In a search for better methods for assessing inpatient SCD pain in adults, we examined several pain intensity and interference measures in both arms of a randomized controlled trial comparing two different opioid PCA therapies. Based upon longitudinal analysis of pain episodes, we found that scores from daily average Visual Analogue Scales (VAS) and several other measures, especially the Brief Pain Inventory (BPI), were sensitive to change in daily improvements in pain intensity associated with resolution of vaso-occlusive pain. In this preliminary trial, the low demand, high basal infusion (LDHI) strategy demonstrated faster, larger improvements in various measures of pain than the high demand, low basal infusion (HDLI) strategy for opioid PCA dosing, however, verification in larger studies is required. The measures and statistical approaches used in this analysis may facilitate design, reduce sample size, and improve analyses of treatment response in future SCD clinical trials of vaso-occlusive episodes.
PMCID: PMC3533241  PMID: 22886853
sickle cell disease; pain; longitudinal models
18.  Effect of functional lumbar stabilization exercises on pain, disability, and kinesiophobia in women with menstrual low back pain: a preliminary trial 
Journal of Chiropractic Medicine  2013;12(3):160-167.
The purpose of this preliminary study was to investigate the effect of functional lumbar stabilization exercises on pain, disability, and kinesiophobia in women with menstrual low back pain (LBP).
Thirty women with menstrual LBP participated in the study. Subjects were assigned to a control group (n = 10, mean age = 25.1 ± 4.7 years) and an intervention group (n = 20, mean age = 21.7±2.4 years). Treatment for the intervention group consisted of functional lumbar stabilization exercises, 10 repetitions each, 3 times a day, for 3 consecutive months. The women in the control group received no exercise and performed their regular activity daily living. Pain intensity using a Numeric Pain Scale (NPS), Oswestry Disability Index (ODI), Roland-Morris Questionnaire (RMQ), and Tampa Scale of Kinesiophobia (TSK) was collected at baseline and at the end of 3 months in both groups.
Statistical analysis (paired t test) revealed a significant decrease in NPS, ODI, RMQ, and TSK after treatment in the intervention group. No significant difference in NPS, ODI, RMQ, or TSK was found between pre- and postmeasurement scores in the control group. In the analysis of covariance, controlling for pretest scores, a significant difference was found between the 2 groups in the postmeasurement score of NPS (P = .01), ODI (P < .001), RMQ (P = .002), and TSK (P = .04).
Lumbar stabilization exercises were shown to improve pain, disability, and kinesiophobia during menstrual LBP for subjects who participated in this preliminary study compared to those who did not receive the intervention.
PMCID: PMC3838710  PMID: 24396316
Low back pain; Menstruation; Exercise; Pain; Disability
19.  Acupuncture for the treatment of severe acute pain in Herpes Zoster: results of a nested, open-label, randomized trial in the VZV Pain Study 
Data on the potential efficacy of acupuncture (AC) in controlling intense or very intense pain in patients with Herpes Zoster (HZ) has not been so far adequately assessed in comparison with standard pharmacological treatment (ST) by a controlled trial design.
Within the VZV Pescara study, pain was assessed in HZ patients on a Visual Analogue Scale (VAS) and by the McGill Pain Questionnaire (MPQ) both at the beginning and at the end of treatment. Response rates, mean changes in pain intensity, differences in total pain burden with an area-under-the-curve (AUC) method over a 1-year follow-up and differences in the incidence of Post-Herpetic Neuralgia (PHN) were evaluated.
One hundred and two patients were randomized to receive either AC (n = 52) or ST (n = 50) for 4 weeks. Groups were comparable regarding age, sex, pain intensity at presentation and missed antiviral prescription. Both interventions were largely effective. No significant differences were observed in response rates (81.6% vs 89.2%, p = 0.8), mean reduction of VAS (4.1 +/- 2.3 vs 4.9 +/- 1.9, p = 0.12) and MPQ scores (1.3 +/- 0.9 vs 1.3 +/- 0.9, p = 0.9), incidence of PHN after 3 months (48.4% vs 46.8%, p = 0.5), and mean AUC during follow-up (199 +/- 136 vs 173 +/- 141, p = 0.4). No serious treatment-related adverse event was observed in both groups.
This controlled and randomized trial provides the first evidence of a potential role of AC for the treatment of acute herpetic pain.
Trial registration
PMCID: PMC3125389  PMID: 21639941
20.  Outcome of transcutaneous electrical nerve stimulation in chronic pain: short-term results of a double-blind, randomised, placebo-controlled trial 
The Journal of Headache and Pain  2006;7(4):196-205.
The aim of this study was to test the efficacy of shortterm transcutaneous electrical nerve stimulation (TENS) treatment in chronic pain with respect to pain intensity and patients’ satisfaction with treatment results. We therefore performed a randomised controlled trial comparing TENS and sham TENS. Patients, researchers and therapists were blinded for treatment allocation. One hundred and sixty-three patients with chronic pain referred to the Pain Centre entered the study. Conventional TENS and sham TENS were applied in the segments of pain, for a period of ten days. Outcome measures were pain intensity (visual analogue scale) and patients’ satisfaction with treatment result (yes or no). The proportions of patients satisfied with treatment result differed significantly for TENS compared to sham TENS (58 and 42.7% respectively, x2=3.8, p=0.05). However, no differences in pain intensity were found for patients treated with TENS or sham TENS. Only for patients satisfied with treatment results pain intensity gradually decrease equally both for TENS and sham TENS with repeated treatment application.
PMCID: PMC3476076  PMID: 16897618
Transcutaneous electric nerve stimulation; Chronic pain; Patient satisfaction; Placebo effect; Duble-blind randomized controlled trial
21.  The Effect of Rosa Damascena Extract on Primary Dysmenorrhea: A Double-blind Cross-over Clinical Trial 
Dysmenorrhea is one of the most common types of cyclic pain that affects 50% of women and girls in their menstrual ages. Because of the side-effects and contraindications of chemical medicines, using herbs has been investigated in treating dysmenorrhea.
The aim of this study was to determine the effect of Rosa damascena extract on primary dysmenorrhea among the students of Kowsar dormitory in Tabriz University of Medical Sciences.
Materials and Methods:
This study was performed in Iran on 92 single 18-24 year old students with BMI :19-25 and obtaining pain intensity score of 5-8 in Visual Analogue Scale that were randomly classified and included in two groups of 46 persons. The participants received two capsules of Mefenamic Acid and Rosa damascena with the similar physical properties in two consecutive cycles per 6 hours for 3 days in a cross-over form. The data were collected through the questionnaire of demographic characteristics and check-list of visual analogue scale. Descriptive statistics and repeated measurement test and independent samples t test by using SPSS (13/win) were used in order to determine and compare the effects of two drugs on dysmenorrheal pain intensity of the groups.
There was a significant difference between the average of pain intensity at different hours of measurement in each group after the end of first cycle and second cycle (P < 0.001). There was no significant difference between the average of pain intensity in two groups in the first cycle (P = 0.35) and second cycle (P = 0.22).
In this study¸ Rosa damascena and Mefenamic acid had similar effects on pain intensity of primary dysmenorrhea . With further studies, Rosa damascena which has no chemical side effects¸ can be suggested for treating primary dysmenorrhea.
PMCID: PMC3964428  PMID: 24719710
Dysmenorrhea; Rosa; Mefenamic Acid
22.  Pregabalin in Treatment-Refractory Fibromyalgia 
Fibromyalgia is a chronic musculoskeletal pain disorder. The pain can be intractable and may not respond to commonly-used treatments, such as tricyclic antidepressants and opioids.
To evaluate pregabalin response in the subset of patients with fibromyalgia whose pain had been judged refractory to other treatments.
Patients had previously participated in a controlled trial of pregabalin and had moderate to severe pain despite treatment with gabapentin, a tricyclic antidepressant, and a third medication (e.g., other anticonvulsants, opioid, selective serotonin reuptake inhibitors, tramadol). Flexible-dose pregabalin 150-600 mg/day was added for 3-month treatment cycles, each followed by 3- to 28-day pregabalin “drug holiday” that lasted until a relapse occurred. Pain intensity was measured using the visual analogue scale of the Short-Form McGill Pain Questionnaire completed at baseline, the end of each 3-month treatment period and at the relapse visit. Analysis was at 15 months (after 5 cycles).
In total, 25 patients were included and 19 completed the 15-month analysis period. At baseline, 88% were receiving ≥1 pain medication. Pregabalin 150-600 mg/day was associated with statistically significant, clinically meaningful pain reduction during each treatment cycle. Pain quickly returned to baseline levels during the “drug holidays” in a median time of 2-4 days. Somnolence (n=5) and dizziness (n=4) were the most common adverse events.
These results suggest that pregabalin may be beneficial in patients with fibromyalgia who have had an unsatisfactory response to treatment with other medications.
PMCID: PMC3026332  PMID: 21270936
Pregabalin; anticonvulsant; fibromyalgia; pain; refractory; relapse; chronic widespread pain; open-label.
23.  Efficacy of Injections with Disci/Rhus Toxicodendron Compositum for Chronic Low Back Pain – A Randomized Placebo-Controlled Trial 
PLoS ONE  2011;6(11):e26166.
The effectiveness of injection therapy for low-back pain is still debatable. We compared the efficacy of local injections of the homeopathic preparation Disci/Rhus toxicodendron compositum (verum) with placebo injections and with no treatment in patients with chronic low back pain.
Methodology/Principal Findings
In a randomized controlled partly double blind multicenter trial patients with chronic low back pain from 9 German outpatient clinics were enrolled and randomly allocated in a 1∶1∶1 ratio to receive subcutaneous injections (verum or placebo) into painful sites on the lower back over 12 treatment sessions within eight weeks, or no treatment (rescue pain medication with paracetamol or NSAIDs). All trial personnel and participants were masked to treatment allocation. The primary outcome measure was the average pain intensity over the last seven days on a visual analogue scale (0–100 mm, 0 = no pain, 100 = worst imaginable pain) after eight weeks. Follow-up was 26 weeks. Primary analysis was by intention to treat. Between August 2007 and June 2008, 150 patients were randomly allocated to three groups (51 verum, 48 placebo and 51 no treatment). The mean baseline-adjusted low back pain intensity at week eight was: verum group 37.0 mm (97.5% CI 25.3;48.8), no treatment group 53.0 (41.8;64.2), and placebo group 41.8 (30.1;53.6). The verum was significantly superior to no treatment (P = 0.001), but not to placebo (P = 0.350). No significant side effects were reported.
The homeopathic preparation was not superior to placebo. Compared to no treatment injections resulted in significant and clinical relevant chronic back pain relief.
Trial Registration NCT00567736
PMCID: PMC3210748  PMID: 22087222
24.  The Effect of the Kinesio Taping and Spiral Taping on Menstrual Pain and Premenstrual Syndrome 
[Purpose] The purpose of this study was to compare the effects of Kinesio taping and spiral taping on menstrual pain and premenstrual syndrome, to investigate the efficacy of the two types of taping as methods for alleviating menstrual pain and premenstrual syndrome. [Subjects and Methods] The subjects of this study were 34 unmarried women. The subjects were randomly divided into a Kinesio taping group, a spiral taping group and a control group. Subjects with a regular menstrual cycle underwent taping a total of six times; twice a week for about three weeks, starting from 14 days before menstruation and continuing until its end. Degrees of menstrual pain and premenstrual syndrome were measured before the application of taping. [Results] The results revealed that Kinesio taping had significant effects on menstrual pain, while spiral taping was effective at alleviating both menstrual pain and premenstrual syndrome. [Conclusion] Both taping methods before menstruation brought significant relief to menstrual pain, which suggests that spiral taping is an effective method of alleviating premenstrual symptoms.
PMCID: PMC3820414  PMID: 24259847
Kinesio taping; Spiral taping; Menstrual pain
25.  First-dose analgesic effect of the cyclo-oxygenase-2 selective inhibitor lumiracoxib in osteoarthritis of the knee: a randomized, double-blind, placebo-controlled comparison with celecoxib [NCT00267215] 
Cyclo-oxygenase-2 selective inhibitors are frequently used to manage osteoarthritis. We compared the analgesic efficacy of the novel cyclo-oxygenase-2 selective inhibitor lumiracoxib (Prexige®) versus placebo and celecoxib in patients with knee osteoarthritis. This seven day, double-blind, placebo and active comparator controlled, parallel group study included 364 patients aged ≥50 years with moderate-to-severe symptomatic knee osteoarthritis. Patients received lumiracoxib 400 mg/day (four times the recommended chronic dose in osteoarthritis; n = 144), placebo (n = 75), or celecoxib 200 mg twice daily (n = 145). The primary variable was actual pain intensity difference (100 mm visual–analogue scale) between baseline and the mean of three hour and five hour assessments after the first dose. Actual pain intensity difference, average and worst pain, pain relief and functional status (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC™]) were measured over seven days. Patients also completed a global evaluation of treatment effect at study end or premature discontinuation. For the primary variable, the superiority of lumiracoxib versus placebo, the noninferiority of lumiracoxib versus celecoxib, and the superiority of lumiracoxib versus celecoxib were assessed by closed test procedure adjusting for multiplicity, thereby maintaining the overall 5% significance level. In addition, celecoxib was assessed versus placebo in a predefined exploratory manner to assess trial sensitivity. Lumiracoxib provided better analgesia than placebo 3–5 hours after the first dose (P = 0.004) through to study end. The estimated difference between lumiracoxib and celecoxib 3–5 hours after the first dose was not significant (P = 0.185). Celecoxib was not significantly different from placebo in this analysis (P = 0.069). At study end 13.9% of lumiracoxib-treated patients reported complete pain relief versus 5.5% and 5.3% of celecoxib and placebo recipients, respectively. WOMAC™ total and subscales improved for both active treatments versus placebo except for difficulty in performing daily activities, for which celecoxib just failed to achieve significance (P = 0.056). In the patient's global evaluation of treatment effect, 58.1% of patients receiving lumiracoxib rated treatment as 'excellent' or 'good', versus 48.6% of celecoxib and 25.3% of placebo patients. Lumiracoxib was well tolerated. The overall incidence of adverse events was similar across treatment groups.
PMCID: PMC1526611  PMID: 16469112

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