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Background

Knee osteoarthritis (OA) is one of the most common and costly chronic musculoskeletal conditions world-wide and is associated with substantial pain and disability. Many people with knee OA also experience co-morbidities that further add to the OA burden. Uptake of and adherence to physical activity recommendations is suboptimal in this patient population, leading to poorer OA outcomes and greater impact of associated co-morbidities. This pragmatic randomised controlled trial will investigate the clinical- and cost-effectiveness of adding telephone coaching to a physiotherapist-delivered physical activity intervention for people with knee OA.

Methods/Design

168 people with clinically diagnosed knee OA will be recruited from the community in metropolitan and regional areas and randomly allocated to physiotherapy only, or physiotherapy plus nurse-delivered telephone coaching. Physiotherapy involves five treatment sessions over 6 months, incorporating a home exercise program of 4–6 exercises (targeting knee extensor and hip abductor strength) and advice to increase daily physical activity. Telephone coaching comprises 6–12 telephone calls over 6 months by health practitioners trained in applying the Health Change Australia (HCA) Model of Health Change to provide behaviour change support. The telephone coaching intervention aims to maximise adherence to the physiotherapy program, as well as facilitate increased levels of participation in general physical activity. The primary outcomes are pain measured by an 11-point numeric rating scale and self-reported physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index subscale after 6 months. Secondary outcomes include physical activity levels, quality-of-life, and potential moderators and mediators of outcomes including self-efficacy, pain coping and depression. Relative cost-effectiveness will be determined from health service usage and outcome data. Follow-up assessments will also occur at 12 and 18 months.

Discussion

The findings will help determine whether the addition of telephone coaching sessions can improve sustainability of outcomes from a physiotherapist-delivered physical activity intervention in people with knee OA.

Trial Registration

Australian New Zealand Clinical Trials Registry reference: ACTRN12612000308897

Background

There is some evidence that acupuncture for pain and osteoarthritis (OA) of the knee is more than a placebo, and short term clinical benefits have been observed when acupuncture is compared to usual care. However there is insufficient evidence on whether clinical benefits of acupuncture are sustained over the longer term. In this study our key objectives are to inform the design parameters for a fully powered pragmatic randomised controlled trial. These objectives include establishing potential recruitment rates, appropriate validated outcome measures, attendance levels for acupuncture treatment, loss to follow up and the sample size for a full scale trial.

Methods

Potential participants aged over 50 with pain and osteoarthritis of the knee were identified from a GP database. Eligible patients were randomised to either 'acupuncture plus usual care' and 'usual care' alone, with allocation appropriately concealed. Acupuncture consisted of up to 10 sessions usually weekly. Outcome measures included Western Ontario and McMaster Universities (WOMAC) index with the sample size for a full scale trial determined from the variance.

Results

From the GP database of 15,927 patients, 335 potential trial participants were identified and invited to participate. After screening responses, 78 (23%) were identified as eligible and 30 patients who responded most promptly were randomised to 'acupuncture plus usual care' (15 patients) and 'usual care' alone (15 patients). Attendance for acupuncture appointments was high at 90% of the maximum. Although the trial was not powered to detect significant changes in outcome, the WOMAC pain index showed a statistically significant reduction at 3 months in the acupuncture group compared to usual care. This was not sustained at 12 months. The sample size for a fully powered two-arm trial was estimated to be 350.

Conclusion

This pilot study provided the evidence that a fully powered study to explore the longer term impact of acupuncture would be worthwhile, and relevant design features for such a trial were determined.

Trial registration number

ISRCTN25134802.

Background

Acupuncture is a popular non-pharmacological modality for treating musculoskeletal pain. Physiotherapists are one of the largest groups of acupuncture providers within the NHS, and they commonly use it alongside advice and exercise. Conclusive evidence of acupuncture's clinical effectiveness and its superiority over sham interventions is lacking. The Arthritis Research Campaign (arc) has funded this randomised sham-controlled trial which addresses three important questions. Firstly, we will determine the additional benefit of true acupuncture when used by physiotherapists alongside advice and exercise for older people presenting to primary care with knee pain. Secondly, we will evaluate sham acupuncture in the same way. Thirdly, we will investigate the treatment preferences and expectations of both the participants and physiotherapists participating in the study, and explore the effect of these on clinical outcome. We will thus investigate whether acupuncture is a useful adjunct to advice and exercise for treating knee pain and gain insight into whether this effect is due to specific needling properties.

Methods/Design

This randomised clinical trial will recruit 350 participants with knee pain to three intervention arms. It is based in 43 community physiotherapy departments in 21 NHS Trusts in the West Midlands and Cheshire regions in England. Patients aged 50 years and over with knee pain will be recruited. Outcome data will be collected by self-complete questionnaires before randomisation, and 6 weeks, 6 months and 12 months after randomisation and by telephone interview 2 weeks after treatment commences. The questionnaires collect demographic details as well as information on knee-related pain, movement and function, pain intensity and affect, main functional problem, illness perceptions, self-efficacy, treatment preference and expectations, general health and quality of life. Participants are randomised to receive a package of advice and exercise; or this package plus real acupuncture; or this package plus sham acupuncture. Treatment details are being collected on a standard proforma. Interventions are delivered by experienced physiotherapists who have all received training in acupuncture to recognised national standards. The primary analysis will investigate the main treatment effects of real or sham acupuncture as an adjunct to advice and exercise.

Discussion

This paper presents detail on the rationale, design, methods, and operational aspects of the trial.

Objectives To analyse the efficacy of acupuncture as a complementary therapy to the pharmacological treatment of osteoarthritis of the knee, with respect to pain relief, reduction of stiffness, and increased physical function during treatment; modifications in the consumption of diclofenac during treatment; and changes in the patient's quality of life.

Design Randomised, controlled, single blind trial, with blinded evaluation and statistical analysis of results.

Setting Pain management unit in a public primary care centre in southern Spain, over a period of two years.

Participants 97 outpatients presenting with osteoarthritis of the knee.

Interventions Patients were randomly separated into two groups, one receiving acupuncture plus diclofenac (n = 48) and the other placebo acupuncture plus diclofenac (n = 49).

Main outcome measures The clinical variables examined included intensity of pain as measured by a visual analogue scale; pain, stiffness, and physical function subscales of the Western Ontario and McMaster Universities (WOMAC) osteoarthritis index; dosage of diclofenac taken during treatment; and the profile of quality of life in the chronically ill (PQLC) instrument, evaluated before and after the treatment programme.

Results 88 patients completed the trial. In the intention to treat analysis, the WOMAC index presented a greater reduction in the intervention group than in the control group (mean difference 23.9, 95% confidence interval 15.0 to 32.8) The reduction was greater in the subscale of functional activity. The same result was observed in the pain visual analogue scale, with a reduction of 26.6 (18.5 to 34.8). The PQLC results indicate that acupuncture treatment produces significant changes in physical capability (P = 0.021) and psychological functioning (P = 0.046). Three patients reported bruising after the acupuncture sessions.

Conclusions Acupuncture plus diclofenac is more effective than placebo acupuncture plus diclofenac for the symptomatic treatment of osteoarthritis of the knee.

Introduction. Acupuncture was recently shown to be effective in the treatment of knee osteoarthritis. However, controversy persists whether the observed effects are specific to acupuncture or merely nonspecific consequences of needling. Therefore, the objective of this study is to determine the efficacy of different acupuncture treatment modalities. Materials and Methods. We compared between three different forms of acupuncture in a prospective randomised trial with a novel double-blinded study design. One-hundred and sixteen patients aged from 35 to 82 with osteoarthritis of the knee were enrolled in three study centres. Interventions were individualised classical/ modern semistandardised acupuncture and non-specific needling. Blinded outcome assessment comprised knee flexibility and changes in pain according to the WOMAC score. Results and Discussion. Improvement in knee flexibility was significantly higher after classical Chinese acupuncture (10.3 degrees; 95% CI 8.9 to 11.7) as compared to modern acupuncture (4.7 degrees; 3.6 to 5.8). All methods achieved pain relief, with a patient response rate of 48 percent for non-specific needling, 64 percent for modern acupuncture, and 73 percent for classical acupuncture. Conclusion. This trial establishes a novel study design enabling double blinding in acupuncture studies. The data suggest a specific effect of acupuncture in knee mobility and both non-specific and specific effects of needling in pain relief.

Background

Knee osteoarthritis (OA) is considered a major public health issue causing chronic disability worldwide with the increasing number of aging people. In China and increasingly worldwide, many sufferers with knee OA are using complementary and alternative medicine including herbal drug, herbal patch, acupuncture and Tuina etc., to alleviate their symptoms. However, evidence gathered from systematic reviews or randomized controlled trials (RCT) has only validated acupuncture for the management of osteoarthritic pain. Moreover, such Traditional Chinese Medicine (TCM) methods above are commonly used in an integrative way. This trial is aimed to compare the efficacy of an individually integrated TCM approach in the management of knee OA with other single treatments as parallel randomized controls.

Methods/design

Five teaching hospitals will participate in this randomized controlled trial. 500 participants, 100 in each hospital, will be randomly assigned to receive oral administration of a Chinese herbal drug (counter osteophytes capsule), topical use of a Chinese herbal patch (Fufnag Zijin patch), acupuncture, Tuina and the individually integrated TCM approach. The individually integrated TCM approach consists of basic treatment of oral counter osteophytes capsule, variable use of Tuina, acupuncture and a herbal patch based on the severity of the patient's symptoms.

The interventions are given for a period of 4 weeks. The primary outcome measure is the self-reported total score using the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures include patient and investigator global assessment of response to treatment, patient and investigator global assessment of OA condition, WOMAC pain, stiffness, and physical function subscales, short-form 36 (SF-36) and TCM assessment of OA condition measured by syndromes questionnaire. Mixed models and sensitivity analysis will be used for the statistical analysis.

Discussion

The trial is designed to test the hypothesis that an individually integrated TCM approach is more effective than four treatment modalities used separately. The major limitation of this study is lack of placebo control and of double blinding.

Trial Registration

Chinese Cochrane Center ChiCTR-TRC-00000176

Background

Knee osteoarthritis is a highly prevalent condition with a significant socioeconomic burden to society. It is known to effect sufferers through pain, loss of function and changes in health related quality of life. Management typically involves pharmacologic and/or exercise based therapy approaches to reduce pain. Previous studies have shown multimodal treatment approaches incorporating manual therapy to be efficacious. The aim of this study is to determine if a manual therapy technique knee protocol can alter the self reported pain experienced by a group of chronic knee osteoarthritis sufferers in a randomised controlled trial.

Methods

43 participants with a chronic, non-progressive history of osteoarthritic knee pain, aged between 47 and 70 years were randomly allocated following a screening procedure to an intervention group (n=26; 18 men and 8 women, mean age 56.5 years) or a control group (n=17; 11 men and 6 women, mean age 54.6 years). Participants were matched for present knee pain intensity measured on a visual analogue scale. The intervention consisted of the Macquarie Injury Management Group Knee Protocol whilst the control involved a non-forceful manual contact to the knee followed by interferential therapy set at zero. Participants received three treatments per week for two consecutive weeks with a follow up immediately after the final treatment. Post-treatment Participants completed 11 questions including present knee pain intensity and feedback regarding their response to treatment utilizing a visual analogue scale. Results were analysed using descriptive statistics.

Results

Prior to the intervention, there was no significant differences in age or present knee pain intensity. Following treatment, the intervention group reported a significant decrease in the present pain severity (mean 1.9) when compared to the control group (mean 3.1). Response to treatment questions indicated that compared to the control group, the intervention group felt the intervention had helped them (intervention mean 7.0; control mean 3.4), felt it decreased their knee symptoms such as crepitus (intervention mean 6.0; control mean 3.4) and improved their knee mobility (intervention mean 6.4; control mean 3.4) and their ability to perform general activities (intervention mean 6.5; control mean 3.8). Importantly the MIMG Knee Protocol intervention group reported no adverse reactions during treatment.

Conclusions

A short-term manual therapy knee protocol significantly reduced pain suffered by participants with osteoarthritic knee pain and resulted in improvements in self-reported knee function immediately after the end of the 2 week treatment period.

Objective To investigate the benefit of adding acupuncture to a course of advice and exercise delivered by physiotherapists for pain reduction in patients with osteoarthritis of the knee.

Design Multicentre, randomised controlled trial.

Setting 37 physiotherapy centres accepting primary care patients referred from general practitioners in the Midlands, United Kingdom.

Participants 352 adults aged 50 or more with a clinical diagnosis of knee osteoarthritis.

Interventions Advice and exercise (n=116), advice and exercise plus true acupuncture (n=117), and advice and exercise plus non-penetrating acupuncture (n=119).

Main outcome measures The primary outcome was change in scores on the Western Ontario and McMaster Universities osteoarthritis index pain subscale at six months. Secondary outcomes included function, pain intensity, and unpleasantness of pain at two weeks, six weeks, six months, and 12 months.

Results Follow-up rate at six months was 94%. The mean (SD) baseline pain score was 9.2 (3.8). At six months mean reductions in pain were 2.28 (3.8) for advice and exercise, 2.32 (3.6) for advice and exercise plus true acupuncture, and 2.53 (4.2) for advice and exercise plus non-penetrating acupuncture. Mean differences in change scores between advice and exercise alone and each acupuncture group were 0.08 (95% confidence interval −1.0 to 0.9) for advice and exercise plus true acupuncture and 0.25 (−0.8 to 1.3) for advice and exercise plus non-penetrating acupuncture. Similar non-significant differences were seen at other follow-up points. Compared with advice and exercise alone there were small, statistically significant improvements in pain intensity and unpleasantness at two and six weeks for true acupuncture and at all follow-up points for non-penetrating acupuncture.

Conclusion The addition of acupuncture to a course of advice and exercise for osteoarthritis of the knee delivered by physiotherapists provided no additional improvement in pain scores. Small benefits in pain intensity and unpleasantness were observed in both acupuncture groups, making it unlikely that this was due to acupuncture needling effects.

Trial registration Current Controlled Trials ISRCTN88597683.

Background

Qualitative studies of participants' experiences in randomised clinical trials (RCTs) suggest that the psychosocial context of treatment in RCTs may be quite different to the psychosocial context of treatment in usual practice. This is important, as the psychosocial context of treatment is known to influence patient outcomes in chronic illness. Few studies have directly compared the psychosocial context of treatment across RCTs and usual practice. In this study, we explored differences in psychosocial context between RCT and usual practice settings, using acupuncture as our model.

Methods

We undertook a secondary analysis of existing qualitative interviews with 54 patients. 27 were drawn from a study of western and traditional acupuncture in usual practice (for a range of painful conditions). 27 were drawn from a qualitative study nested in an RCT of western acupuncture for osteoarthritis of the hip or knee. We used qualitative analysis software to facilitate an inductive thematic analysis in which we identified three main themes.

Results

In usual practice, starting acupuncture was more likely to be embedded in an active and ongoing search for pain relief, whereas in the RCT starting acupuncture was opportunistic. Usual practice patients reported few uncertainties and these had minimal consequences for them. In the RCT, patients experienced considerable uncertainties about their treatment and its effectiveness, and were particularly concerned about whether they were receiving real (or fake) acupuncture. Patients stopped acupuncture only at the end of the fixed course of treatment in the RCT, which was similar to those receiving acupuncture in the public sector National Health Service (NHS). In comparison, private sector patients re-evaluated and re-negotiated treatments particularly when starting to use acupuncture.

Conclusions

Differences in psychosocial context between RCTs and usual practice could reduce the impact of acupuncture in RCT settings and/or lead to under-reporting of benefit by patients in trials. New trial designs that ensure participants' experiences are similar to usual practice should minimise differences in psychosocial context and help attenuate these potentially confounding effects.

Background

Chronic back pain is a major public health problem and the primary reason patients seek acupuncture treatment. Therefore, an objective assessment of acupuncture efficacy is critical for making informed decisions about its appropriate role for patients with this common condition. This study addresses methodological shortcomings that have plagued previous studies evaluating acupuncture for chronic low back pain.

Methods and Design

A total of 640 participants (160 in each of four arms) between the ages of 18 and 70 years of age who have low back pain lasting at least 3 months will be recruited from integrated health care delivery systems in Seattle and Oakland. They will be randomized to one of two forms of Traditional Chinese Medical (TCM) acupuncture needling (individualized or standardized), a "control" group (simulated acupuncture), or to continued usual medical care. Ten treatments will be provided over 7 weeks. Study participants and the "Diagnostician" acupuncturists who evaluate participants and propose individualized treatments will be masked to the acupuncture treatment actually assigned each participant. The "Therapist" acupuncturists providing the treatments will not be masked but will have limited verbal interaction with participants. The primary outcomes, standard measures of dysfunction and bothersomeness of low back pain, will be assessed at baseline, and after 8, 26, and 52 weeks by telephone interviewers masked to treatment assignment. General health status, satisfaction with back care, days of back-related disability, and use and costs of healthcare services for back pain will also be measured. The primary analysis comparing outcomes by randomized treatment assignment will be analysis of covariance adjusted for baseline value. For both primary outcome measures, this trial will have 99% power to detect the presence of a minimal clinically significant difference among all four treatment groups and over 80% power for most pairwise comparisons. Secondary analyses will compare the proportions of participants in each group that improve by a clinically meaningful amount.

Conclusion

Results of this trial will help clarify the value of acupuncture needling as a treatment for chronic low back pain.

Trial registration

Clinical Trials.gov NCT00065585.

Background

Acupuncture is widely-used to treat patients with low back pain, despite insufficient evidence of the technique's efficacy for acute back pain. Motion style acupuncture treatment (MSAT) is a non-traditional acupuncture treatment requiring a patient to exercise while receiving acupuncture. In Korea, MSAT is used to reduce musculoskeletal pain and improve functional status. The study aims to evaluate the effect of MSAT on acute low back pain with severe disability.

Methods/Design

This study is a multicenter, randomized, active-controlled trial with two parallel arms. Participants with acute low back pain and severe functional disability, defined as an Oswestry Disability Index (ODI) value > 60%, will be randomly allocated to the acupuncture group and the nonsteroidal anti-inflammatory drug (NSAID) injection group. The acupuncture group will receive MSAT and the NSAID injection group will receive an intramuscular injection of diclofenac. All procedures will be limited to one session and the symptoms before and after treatment will be measured by assessors blinded to treatment allocation. The primary outcome will be measured at 30 minutes after treatment using the numerical rating scale (NRS) of low back pain while the patient is moving. Secondary outcomes will be measured at 30 minutes after treatment using the NRS of leg pain, ODI, patient global impression of change, range of motion (ROM) of the lumbar spine, and degrees of straight leg raising (SLR). Post-treatment follow-up will be performed to measure primary and secondary outcomes with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment.

Discussion

The results of this trial will be discussed.

Trial Registration

ClinicalTrial.gov NCT01315561

Background

Patellofemoral pain syndrome is a highly prevalent musculoskeletal overuse condition that has a significant impact on participation in daily and physical activities. A recent systematic review highlighted the lack of high quality evidence from randomised controlled trials for the conservative management of patellofemoral pain syndrome. Although foot orthoses are a commonly used intervention for patellofemoral pain syndrome, only two pilot studies with short term follow up have been conducted into their clinical efficacy.

Methods/design

A randomised single-blinded clinical trial will be conducted to investigate the clinical efficacy and cost effectiveness of foot orthoses in the management of patellofemoral pain syndrome. One hundred and seventy-six participants aged 18–40 with anterior or retropatellar knee pain of non-traumatic origin and at least six weeks duration will be recruited from the greater Brisbane area in Queensland, Australia through print, radio and television advertising. Suitable participants will be randomly allocated to receive either foot orthoses, flat insoles, physiotherapy or a combined intervention of foot orthoses and physiotherapy, and will attend six visits with a physiotherapist over a 6 week period. Outcome will be measured at 6, 12 and 52 weeks using primary outcome measures of usual and worst pain visual analogue scale, patient perceived treatment effect, perceived global effect, the Functional Index Questionnaire, and the Anterior Knee Pain Scale. Secondary outcome measures will include the Lower Extremity Functional Scale, McGill Pain Questionnaire, 36-Item Short-Form Health Survey, Hospital Anxiety and Depression Scale, Patient-Specific Functional Scale, Physical Activity Level in the Previous Week, pressure pain threshold and physical measures of step and squat tests. Cost-effectiveness analysis will be based on treatment effectiveness against resource usage recorded in treatment logs and self-reported diaries.

Discussion

The randomised clinical trial will utilise high-quality methodologies in accordance with CONSORT guidelines, in order to contribute to the limited knowledge base regarding the clinical efficacy of foot orthoses in the management of patellofemoral pain syndrome, and provide practitioners with high-quality evidence upon which to base clinical decisions.

Trial registration

Australian Clinical Trials Registry ACTRN012605000463673

ClinicalTrials.gov NCT00118521

Objectives

To compare the efficacy of acupuncture and conventional massage for the treatment of chronic neck pain.

Design

Prospective, randomised, placebo controlled trial.

Setting

Three outpatient departments in Germany.

Participants

177 patients aged 18-85 years with chronic neck pain.

Interventions

Patients were randomly allocated to five treatments over three weeks with acupuncture (56), massage (60), or “sham” laser acupuncture (61).

Main outcome measures

Primary outcome measure: maximum pain related to motion (visual analogue scale) irrespective of direction of movement one week after treatment. Secondary outcome measures: range of motion (3D ultrasound real time motion analyser), pain related to movement in six directions (visual analogue scale), pressure pain threshold (pressure algometer), changes of spontaneous pain, motion related pain, global complaints (seven point scale), and quality of life (SF-36). Assessments were performed before, during, and one week and three months after treatment. Patients' beliefs in treatment were assessed.

Results

One week after five treatments the acupuncture group showed a significantly greater improvement in motion related pain compared with massage (difference 24.22 (95% confidence interval 16.5 to 31.9), P=0.0052) but not compared with sham laser (17.28 (10.0 to 24.6), P=0.327). Differences between acupuncture and massage or sham laser were greater in the subgroup who had had pain for longer than five years (n=75) and in patients with myofascial pain syndrome (n=129). The acupuncture group had the best results in most secondary outcome measures. There were no differences in patients' beliefs in treatment.

Conclusions

Acupuncture is an effective short term treatment for patients with chronic neck pain, but there is only limited evidence for long term effects after five treatments.

What is already known on this topicAcupuncture is a widespread complementary treatmentEvidence from trials have given conflicting results on its use in the treatment of neck pain because of methodological shortcomings and because effects were compared either with alternative treatments or with different sham procedures imitating acupuncture, but not bothWhat this study addsCompared with sham laser acupuncture and massage, needle acupuncture has beneficial effects on mobility and pain related to motion in patients with chronic neck painAcupuncture was clearly more effective than massage, but differences were not always significant compared with sham laser acupunctureAcupuncture was the best treatment for patients with the myofascial syndrome and those who had had pain for longer than five years

Background

Migraine is a chronic neurologic disease that can severely affect the patient's quality of life. Although in recent years many randomised studies have been carried out to investigate the effectiveness of acupuncture as a treatment for migraine, it remains a controversial issue. Our aim is to determine whether acupuncture, applied under real conditions of clinical practice in the area of primary healthcare, is more effective than conventional treatment.

Methods/Design

The design consists of a pragmatic multi-centre, three-armed randomised controlled trial, complemented with an economic evaluation of the results achieved, comparing the effectiveness of verum acupuncture with sham acupuncture, and with a control group receiving normal care only.

Patients eligible for inclusion will be those presenting in general practice with migraine and for whom their General Practitioner (GP) is considering referral for acupuncture. Sampling will be by consecutive selection, and by randomised allocation to the three branches of the study, in a centralised way following a 1:1:1 distribution (verum acupuncture; sham acupuncture; conventional treatment). Secondly, one patient in three will be randomly selected from each of the acupuncture (verum or sham) groups for a brain perfusion study (by single photon emission tomography). The treatment with verum acupuncture will consist of 8 treatment sessions, once a week, at points selected individually by the acupuncturist. The sham acupuncture group will receive 8 sessions, one per week, with treatment being applied at non-acupuncture points in the dorsal and lumbar regions, using the minimal puncture technique. The control group will be given conventional treatment, as will the other two groups.

Discussion

This trial will contribute to available evidence on acupuncture for the treatment of migraine. The primary endpoint is the difference in the number of days with migraine among the three groups, between the baseline period (the 4 weeks prior to the start of treatment) and the period from weeks 9 to 12. As a secondary aspect, we shall record the index of laterality and the percentage of change in the mean count per pixel in each region of interest measured by the brain perfusion tomography, performed on a subsample of the patients within the real and sham acupuncture groups.

Trial registration

Current Controlled Trials ISRCTN98703707.

Background

Chronic musculoskeletal pain is common and has been increasingly managed by opioid medications, of which the long-term efficacy is unknown. Furthermore, there is evidence that long-term use of opioids is associated with reduced pain control, declining physical function and quality of life, and could hinder the goals of integrated pain management. Electroacupuncture (EA) has been shown to be effective in reducing postoperative opioid consumption. Limited evidence suggests that acupuncture could assist patients with chronic pain to reduce their requirements for opioids.

The proposed research aims to assess if EA is an effective adjunct therapy to standard pain and medication management in reducing opioids use by patients with chronic musculoskeletal pain.

Methods

In this multicentre, randomised, sham-acupuncture controlled, three-arm clinical trial, 316 patients regularly taking opioids for pain control and meeting the defined selection criteria will be recruited from pain management centres and clinics of primary care providers in Victoria, Australia. After a four-week run-in period, the participants are randomly assigned to one of three treatment groups to receive EA, sham EA or no-EA with a ratio of 2:1:1. All participants receive routine pain medication management delivered and supervised by the trial medical doctors. Twelve sessions of semi-structured EA or sham EA treatment are delivered over 10 weeks. Upon completion of the acupuncture treatment period, there is a 12-week follow-up. In total, participants are involved in the trial for 26 weeks. Outcome measures of opioid and non-opioid medication consumption, pain scores and opioid-related adverse events are documented throughout the study. Quality of life, depression, function, and attitude to pain medications are also assessed.

Discussion

This randomised controlled trial will determine whether EA is of significant clinical value in assisting the management of debilitating chronic pain by reducing opioids consumption and their associated adverse events, as well as improving the quality of life for those with chronic pain. Such an outcome will provide the rationale for including EA into multidisciplinary programmes for effective management of chronic musculoskeletal pain.

Trial registration

Australian New Zealand Clinical Trial Registry (ACTRN12609000676213)

http://www.anzctr.org.au/trial_view.aspx?ID=308008

Objective To investigate the efficacy of a programme of manual therapy and exercise treatment compared with placebo treatment delivered by physiotherapists for people with chronic rotator cuff disease.

Design Randomised, participant and single assessor blinded, placebo controlled trial.

Setting Metropolitan region of Melbourne, Victoria, Australia.

Participants 120 participants with chronic (>3 months) rotator cuff disease recruited through medical practitioners and from the community.

Interventions The active treatment comprised a manual therapy and home exercise programme; the placebo treatment comprised inactive ultrasound therapy and application of an inert gel. Participants in both groups received 10 sessions of individual standardised treatment over 10 weeks. For the following 12 weeks, the active group continued the home exercise programme and the placebo group received no treatment.

Main outcome measures The primary outcomes were pain and function measured by the shoulder pain and disability index, average pain on movement measured on an 11 point numerical rating scale, and participants’ perceived global rating of overall change.

Results 112 (93%) participants completed the 22 week trial. At 11 weeks no difference was found between groups for change in shoulder pain and disability index (3.6, 95% confidence interval −2.1 to 9.4) or change in pain (0.7, −0.1 to 1.5); both groups showed significant improvements. More participants in the active group reported a successful outcome (defined as “much better”), although the difference was not statistically significant: 42% (24/57) of active participants and 30% (18/61) of placebo participants (relative risk 1.43, 0.87 to 2.34). The active group showed a significantly greater improvement in shoulder pain and disability index than did the placebo group at 22 weeks (between group difference 7.1, 0.3 to 13.9), although no significant difference existed between groups for change in pain (0.9, −0.03 to 1.7) or for the percentage of participants reporting a successful treatment outcome (relative risk 1.39, 0.94 to 2.03). Several secondary outcomes favoured the active group, including shoulder pain and disability index function score, muscle strength, interference with activity, and quality of life.

Conclusion A standardised programme of manual therapy and home exercise did not confer additional immediate benefits for pain and function compared with a realistic placebo treatment that controlled for therapists’ contact in middle aged to older adults with chronic rotator cuff disease. However, greater improvements were apparent at follow-up, particularly in shoulder function and strength, suggesting that benefits with active treatment take longer to manifest.

Trial registration Clinical trials NCT00415441.

Objective To compare the clinical effectiveness of doctors and nurses in undertaking upper and lower gastrointestinal endoscopy.

Design Pragmatic trial with Zelen’s randomisation before consent to minimise distortion of existing practice.

Setting 23 hospitals in the United Kingdom. In six hospitals, nurses undertook both upper and lower gastrointestinal endoscopy, yielding a total of 29 centres.

Participants 67 doctors and 30 nurses. Of 4964 potentially eligible patients, we randomised 4128 (83%) and recruited 1888 (38%) from July 2002 to June 2003.

Interventions Diagnostic upper gastrointestinal endoscopy and flexible sigmoidoscopy, undertaken with or without sedation, with the standard preparation, techniques, and protocols of participating hospitals. After referral for either procedure, patients were randomised between doctors and nurses.

Main outcome measures Gastrointestinal symptom rating questionnaire (primary outcome), gastrointestinal endoscopy satisfaction questionnaire and state-trait anxiety inventory (all analysed by intention to treat); immediate and delayed complications; quality of examination and corresponding report; patients’ preferences for operator; and new diagnoses at one year (all analysed according to who carried out the procedure).

Results There was no significant difference between groups in outcome at one day, one month, or one year after endoscopy, except that patients were more satisfied with nurses after one day. Nurses were also more thorough than doctors in examining the stomach and oesophagus. While quality of life scores were slightly better in patients the doctor group, this was not statistically significant.

Conclusions Diagnostic endoscopy can be undertaken safely and effectively by nurses.

Trial registration International standard RCT 82765705

Background

People who present to hospital after intentionally harming themselves pose a common and important problem. Previous reviews of interventions have been inconclusive as existing trials have been under powered and done on unrepresentative populations. These reviews have however indicated that problem solving therapy and regular written communications after the self-harm attempt may be an effective treatment. This protocol describes a large pragmatic trial of a package of measures which include problem solving therapy, regular written communication, patient support, cultural assessment, improved access to primary care and a risk management strategy in people who present to hospital after self-harm using a novel design.

Methods

We propose to use a double consent Zelen design where participants are randomised prior to giving consent to enrol a large representative cohort of patients. The main outcome will be hospital attendance following repetition of self-harm, in the 12 months after recruitment with secondary outcomes of self reported self-harm, hopelessness, anxiety, depression, quality of life, social function and hospital use at three months and one year.

Discussion

A strength of the study is that it is a pragmatic trial which aims to recruit large numbers and does not exclude people if English is not their first language. A potential limitation is the analysis of the results which is complex and may underestimate any effect if a large number of people refuse their consent in the group randomised to problem solving therapy as they will effectively cross over to the treatment as usual group. However the primary analysis is a true intention to treat analysis of everyone randomised which includes both those who consent and do not consent to participate in the study. This provides information about how the intervention will work in practice in a representative population which is a major advance in this study compared to what has been done before.

Trial registration

Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000641291

Objectives

To determine whether a home based exercise programme can improve outcomes in patients with knee pain.

Design

Pragmatic, factorial randomised controlled trial of two years' duration.

Setting

Two general practices in Nottingham.

Participants

786 men and women aged ⩾45 years with self reported knee pain.

Interventions

Participants were randomised to four groups to receive exercise therapy, monthly telephone contact, exercise therapy plus telephone contact, or no intervention. Patients in the no intervention and combined exercise and telephone groups were randomised to receive or not receive a placebo health food tablet.

Main outcome measures

Primary outcome was self reported score for knee pain on the Western Ontario and McMaster universities (WOMAC) osteoarthritis index at two years. Secondary outcomes included knee specific physical function and stiffness (scored on WOMAC index), general physical function (scored on SF-36 questionnaire), psychological outlook (scored on hospital anxiety and depression scale), and isometric muscle strength.

Results

600 (76.3%) participants completed the study. At 24 months, highly significant reductions in knee pain were apparent for the pooled exercise groups compared with the non-exercise groups (mean difference –0.82, 95% confidence interval –1.3 to –0.3). Similar improvements were observed at 6, 12, and 18 months. Regular telephone contact alone did not reduce pain. The reduction in pain was greater the closer patients adhered to the exercise plan.

Conclusions

A simple home based exercise programme can significantly reduce knee pain. The lack of improvement in patients who received only telephone contact suggests that improvements are not just due to psychosocial effects because of contact with the therapist.

What is already known on this topicPhysiotherapy is often prescribed for the treatment of knee painPrevious trials have usually been short and used intensive supervision and sophisticated equipmentThe impact of psychological factors in reducing pain is unclearWhat this study addsHome based programmes involving exercise for up to 30 minutes a day significantly reduce self reported knee painSocial support alone does not improve health outcomesReductions in pain are greater for patients the closer they adhere to exercise programmes

Objectives To study the analgesic effect of acupuncture and placebo acupuncture and to explore whether the type of the placebo acupuncture is associated with the estimated effect of acupuncture.

Design Systematic review and meta-analysis of three armed randomised clinical trials.

Data sources Cochrane Library, Medline, Embase, Biological Abstracts, and PsycLIT.

Data extraction and analysis Standardised mean differences from each trial were used to estimate the effect of acupuncture and placebo acupuncture. The different types of placebo acupuncture were ranked from 1 to 5 according to assessment of the possibility of a physiological effect, and this ranking was meta-regressed with the effect of acupuncture.

Data synthesis Thirteen trials (3025 patients) involving a variety of pain conditions were eligible. The allocation of patients was adequately concealed in eight trials. The clinicians managing the acupuncture and placebo acupuncture treatments were not blinded in any of the trials. One clearly outlying trial (70 patients) was excluded. A small difference was found between acupuncture and placebo acupuncture: standardised mean difference −0.17 (95% confidence interval −0.26 to −0.08), corresponding to 4 mm (2 mm to 6 mm) on a 100 mm visual analogue scale. No statistically significant heterogeneity was present (P=0.10, I2=36%). A moderate difference was found between placebo acupuncture and no acupuncture: standardised mean difference −0.42 (−0.60 to −0.23). However, considerable heterogeneity (P<0.001, I2=66%) was also found, as large trials reported both small and large effects of placebo. No association was detected between the type of placebo acupuncture and the effect of acupuncture (P=0.60).

Conclusions A small analgesic effect of acupuncture was found, which seems to lack clinical relevance and cannot be clearly distinguished from bias. Whether needling at acupuncture points, or at any site, reduces pain independently of the psychological impact of the treatment ritual is unclear.

Objective

To determine whether spa therapy, plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment, in the management of knee osteoarthritis.

Methods

Large multicentre randomised prospective clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria, attending French spa resorts as outpatients between June 2006 and April 2007. Zelen randomisation was used so patients were ignorant of the other group and spa personnel were not told which patients were participating. The main endpoint criteria were patient self-assessed. All patients continued usual treatments and performed daily standardised home exercises. The spa therapy group also received 18 days of spa therapy (massages, showers, mud and pool sessions).

Main Endpoint

The number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery.

Results

The intention to treat analysis included 187 controls and 195 spa therapy patients. At 6 months, 99/195 (50.8%) spa group patients had MCII and 68/187 (36.4%) controls (χ2=8.05; df=1; p=0.005). However, no improvement in quality of life (Short Form 36) or patient acceptable symptom state was observed at 6 months.

Conclusion

For patients with knee osteoarthritis a 3-week course of spa therapy together with home exercises and usual pharmacological treatments offers benefit after 6 months compared with exercises and usual treatment alone, and is well tolerated.

Trial registration number NCT00348777.

Background

The Hip & Knee Book: Helping you cope with osteoarthritis was developed to change disadvantageous beliefs and encourage physical activity in people with hip or knee osteoarthritis.

Aim

To assess the feasibility of conducting a definitive randomised controlled trial (RCT) of this evidence-based booklet in people with hip or knee osteoarthritis.

Design

Phase II feasibility randomised controlled trial (RCT).

Method

Computerised searches of patients' record databases identified people with osteoarthritis of the hip or knee, who were invited to participate in the RCT comparing the new booklet with a control booklet. Outcomes were measured at baseline, 1 month, and 3 months, and included: beliefs about hip and knee pain, exercise, and fear avoidance; level of physical activity; and health service use.

Results

The trial methods were feasible in terms of recruitment, randomisation, and follow-up, but most participants recruited had longstanding established symptoms. After one and 3 months, there was a small relative improvement in illness, exercise, and fear-avoidance beliefs and physical activity level in The Hip & Knee Book group (n = 59) compared with the control group (n = 60), which provides some proof of principle for using these outcomes in future trials.

Conclusion

This feasibility study provided proof of principle for testing The Hip & Knee Book in a larger definitive RCT.

Objective To assess the effect of lateral wedge insoles compared with flat control insoles on improving symptoms and slowing structural disease progression in medial knee osteoarthritis.

Design Randomised controlled trial.

Setting Community in Melbourne, Australia.

Participants 200 people aged 50 or more with clinical and radiographic diagnosis of mild to moderately severe medial knee osteoarthritis.

Interventions Full length 5 degree lateral wedged insoles or flat control insoles worn inside the shoes daily for 12 months.

Main outcome measures Primary symptomatic outcome was change in overall knee pain (past week) measured on an 11 point numerical rating scale. Primary structural outcome was change in volume of medial tibial cartilage from magnetic resonance imaging scans. Secondary clinical outcomes included changes in measures of pain, function, stiffness, and health related quality of life. Secondary structural outcomes included progression of medial cartilage defects and bone marrow lesions.

Results Between group differences did not differ significantly for the primary outcomes of change in overall pain (−0.3 points, 95% confidence intervals −1.0 to 0.3) and change in medial tibial cartilage volume (−0.4 mm3, 95% confidence interval −15.4 to 14.6), and confidence intervals did not include minimal clinically important differences. None of the changes in secondary outcomes showed differences between groups.

Conclusion Lateral wedge insoles worn for 12 months provided no symptomatic or structural benefits compared with flat control insoles.

Trial registration Australian New Zealand Clinical Trials Registry ACTR12605000503628 and ClinicalTrials.gov NCT00415259.

INTRODUCTION

Chronic low back pain is a common condition affecting a significant proportion of the population and has large economic implications on the society. Acupuncture has grown in popularity as an alternative therapy for chronic low back pain. Recent National Institute for Health and Clinical Excellence (NICE) guidelines on low back pain offer a course of acupuncture as a baseline treatment option according to patient preference. The aim of this systematic review was to evaluate if this treatment option is justified in view of recent evidence available on the efficacy of acupuncture.

MATERIALS AND METHODS

Studies included were identified by a PubMed search for relevant, randomised, controlled trials on the 23 July 2009. A systematic review was performed.

RESULTS

Fifteen randomised controlled trials were identified. Of these, four met the eligibility criteria and were critically appraised. These trials suggest acupuncture can be superior to usual care in treating chronic low back pain, especially, when patients have positive expectations about acupuncture.

CONCLUSIONS

NICE guidelines of a course of acupuncture, offered according to patient preference as a treatment option for chronic low back pain, are justified.

Abstract

On November 8–9, 2007, the Society for Acupuncture Research (SAR) hosted an international conference to mark the tenth anniversary of the landmark National Institutes of Health Consensus Development Conference on Acupuncture. More than 300 acupuncture researchers, practitioners, students, funding agency personnel, and health policy analysts from 20 countries attended the SAR meeting held at the University of Maryland School of Medicine, Baltimore, MD. This paper summarizes important invited lectures in the area of clinical research. Specifically, included are: a review of the recently conducted German trials and observational studies on low-back pain (LBP), gonarthrosis, migraine, and tension-type headache (the Acupuncture Research Trials and the German Acupuncture Trials, plus observational studies); a systematic review of acupuncture treatment for knee osteoarthritis (OA); and an overview of acupuncture trials in neurologic conditions, LBP, women's health, psychiatric disorders, and functional bowel disorders. A summary of the use of acupuncture in cancer care is also provided. Researchers involved in the German trials concluded that acupuncture is effective for treating chronic pain, but the correct selection of acupuncture points seems to play a limited role; no conclusions could be drawn about the placebo aspect of acupuncture, due to the design of the studies. Overall, when compared to sham, acupuncture did not show a benefit in treating knee OA or LBP, but acupuncture was better than a wait-list control and standard of care, respectively. In women's health, acupuncture has been found to be beneficial for patients with premenstrual syndrome, dysmenorrhea, several pregnancy-related conditions, and nausea in females who have cancers. Evidence on moxibustion for breech presentation, induction of labor, and reduction of menopausal symptoms is still inconclusive. In mental health, evidence for acupuncture's efficacy in treating neurologic and functional bowel disorder is still inconclusive. For chronic cancer-related problems such as pain, acupuncture may work well in stand-alone clinics; however, for acute or treatment-related symptoms, integration of acupuncture care into a busy and complex clinical environment is unlikely, unless compelling evidence of a considerable patient benefit can be established.