Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial.

BACKGROUND: Management of chronic neck pain may benefit from additional active self-care-oriented approaches. OBJECTIVE: To evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain. DESIGN: Three-group randomized, controlled trial. (Current Controlled Trials: ISRCTN15186354). SETTING: U.K. primary care. PARTICIPANTS: Persons with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology. INTERVENTION: 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. MEASUREMENTS: NPQ score (primary outcome) at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes). RESULTS: 517 patients were recruited, and the median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention. LIMITATION: Practitioners belonged to the 2 main U.K.-based professional associations, which may limit generalizability of the findings. CONCLUSION: Acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained. PRIMARY FUNDING SOURCE: Arthritis Research UK.

Validity of single item responses to short message service texts to monitor depression: an mHealth sub-study of the UK ACUDep trial.

BACKGROUND: An increasing number of research designs are using text messaging (SMS) as a means of self-reported symptom and outcome monitoring in a variety of long-term health conditions, including severity ratings of depressed mood. The validity of such a single item SMS score to measure latent depression is not currently known and is vital if SMS data are to inform clinical evaluation in the future. METHODS: A sub-set of depressed participants in the UK ACUDep trial submitted a single SMS text score (R-SMS-DS) between 1 and 9 on how depressed they felt around the same time as completing the PHQ-9 depression questionnaire on paper at 3 months follow-up of the trial. Exploratory categorical data factor analysis (EFA) was used to ascertain the alignment of R-SMS-DS scores with the factor structure of the PHQ-9. Any response bias with regard to age or gender was assessed by differential item functioning (DIF) analysis. RESULTS: Depression scores based on the PHQ-9 and R-SMS-DS at 3 months were available for 337 participants (74 % female; mean age: 42 years, SD = 11.1), 213 of which completed the two outcomes within 6 days of each other. R-SMS-DS scores aligned with the underlying latent depression of the PHQ-9 (factor loading of 0.656) and in particular its affective rather than somatic dimension. The R-SMS-DS score was most strongly correlated with depressed mood (r = 0.607), feeling bad about oneself (r = 0.588) and anhedonia (r = 0.573). R-SMS-DS responses were invariant with respect to gender (p = 0.302). However, there was some evidence for age related response bias (p = 0.031), with older participants being more likely to endorse lower R-SMS-DS scores than younger ones. CONCLUSIONS: The R-SMS-DS used in the ACUDep trial was found to be a valid measure of latent affective depression with no gender related response bias. This text message item may therefore represent a useful assessment and monitoring tool meriting evaluation in further research. For future study designs we recommend the collection of outcome data by new health technologies in combination with gold standard instruments to ensure concurrent validity.

Feasibility, acceptability and validity of SMS text messaging for measuring change in depression during a randomised controlled trial.

BACKGROUND: Despite widespread popularity, text messaging has rarely been used for data collection in clinical research. This paper reports on the development, feasibility, acceptability, validity, and discriminant utility of a single item depression rating scale, delivered weekly via an automated SMS system, as part of a large randomised controlled trial. METHODS: 755 depressed patients (BDI-II score ≥20) were recruited from primary care into a randomised trial of acupuncture versus counselling or usual care, and invited to opt into a repeated-measures text messaging sub-study. Two weeks following random allocation, trial participants were sent a weekly text message for 15 weeks. Texts were a single question asking, on a scale from 1 to 9, the extent to which they felt depressed. Feasibility and acceptability of the automated SMS system were evaluated according to cost, ease of implementation, proportion consenting, response rates, and qualitative feedback. Concurrent validity was estimated by correlating SMS responses with the Patient Health Questionnaire (PHQ-9). SMS responses were compared between groups over time to explore treatment effects. RESULTS: 527 (69.8%) trial participants consented to the texting sub-study, of whom 498 (94.5%) responded to at least one message. Participants provided a valid response to an average of 12.5 messages. Invalid responses accounted for 1.1% of texts. The automated SMS system was quick to set-up, inexpensive, and well received. Comparison of PHQ-9 and SMS responses at 3 months demonstrated a moderate to high degree of agreement (Kendall's tau-b = 0.57, p < 0.0001, n = 220). SMS depression scores over the 15 weeks differed significantly between trial arms (p = 0.007), with participants allocated to the acupuncture and counselling arms reporting improved depression outcomes compared to usual GP care alone, which reached statistical significance ten weeks after randomisation. Overall, the single item SMS scale also appeared more responsive to changes in depression, resulting from treatment, than the PHQ-9. CONCLUSIONS: Automated SMS systems offer a feasible and acceptable means of monitoring depression within clinical research. This study provides clear evidence to support the regular use of a simple SMS scale as a sensitive and valid outcome measure of depression within future randomised controlled trials. TRIAL REGISTRATION: Current Controlled Trials - ISRCTN63787732 http://www.controlled-trials.com/ISRCTN63787732/ACUDEP Date of registration: 15/12/2009.

Acupuncture and counselling for depression in primary care: a randomised controlled trial.

BACKGROUND: Depression is a significant cause of morbidity. Many patients have communicated an interest in non-pharmacological therapies to their general practitioners. Systematic reviews of acupuncture and counselling for depression in primary care have identified limited evidence. The aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care. METHODS AND FINDINGS: In a randomised controlled trial, 755 patients with depression (Beck Depression Inventory BDI-II score ≥ 20) were recruited from 27 primary care practices in the North of England. Patients were randomised to one of three arms using a ratio of 2.2.1 to acupuncture (302), counselling (302), and usual care alone (151). The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat. PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of ten sessions for acupuncture and nine sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 months for acupuncture (-2.46, 95% CI -3.72 to -1.21) and counselling (-1.73, 95% CI -3.00 to -0.45), and over 12 months for acupuncture (-1.55, 95% CI -2.41 to -0.70) and counselling (-1.50, 95% CI -2.43 to -0.58). Differences between acupuncture and counselling were not significant. In terms of limitations, the trial was not designed to separate out specific from non-specific effects. No serious treatment-related adverse events were reported. CONCLUSIONS: In this randomised controlled trial of acupuncture and counselling for patients presenting with depression, after having consulted their general practitioner in primary care, both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN63787732 Please see later in the article for the Editors' Summary.

An economic evaluation of Alexander Technique lessons or acupuncture sessions for patients with chronic neck pain: A randomized trial (ATLAS).

OBJECTIVES: To assess the cost-effectiveness of acupuncture and usual care, and Alexander Technique lessons and usual care, compared with usual GP care alone for chronic neck pain patients. METHODS: An economic evaluation was undertaken alongside the ATLAS trial, taking both NHS and wider societal viewpoints. Participants were offered up to twelve acupuncture sessions or twenty Alexander lessons (equivalent overall contact time). Costs were in pounds sterling. Effectiveness was measured using the generic EQ-5D to calculate quality adjusted life years (QALYs), as well as using a specific neck pain measure-the Northwick Park Neck Pain Questionnaire (NPQ). RESULTS: In the base case analysis, incremental QALY gains were 0.032 and 0.025 in the acupuncture and Alexander groups, respectively, in comparison to usual GP care, indicating moderate health benefits for both interventions. Incremental costs were £451 for acupuncture and £667 for Alexander, mainly driven by intervention costs. Acupuncture was likely to be cost-effective (ICER = £18,767/QALY bootstrapped 95% CI £4,426 to £74,562) and was robust to most sensitivity analyses. Alexander lessons were not cost-effective at the lower NICE threshold of £20,000/QALY (£25,101/QALY bootstrapped 95% CI -£150,208 to £248,697) but may be at £30,000/QALY, however, there was considerable statistical uncertainty in all tested scenarios. CONCLUSIONS: In comparison with usual care, acupuncture is likely to be cost-effective for chronic neck pain, whereas, largely due to higher intervention costs, Alexander lessons are unlikely to be cost-effective. However, there were high levels of missing data and further research is needed to assess the long-term cost-effectiveness of these interventions.

Text message reminders to improve questionnaire response rates.

OBJECTIVES: To assess whether short message service (SMS) text messages sent as prenotification or postnotification reminders improve questionnaire response rates in randomized controlled trial (RCT) follow-up. STUDY DESIGN AND SETTING: Three "trials within a trial" assessed text message notifications sent before or after receipt of a follow-up questionnaire within an RCT for patients with depression. Consenting patients (n = 523) were randomized to receive a prenotification or no notification at 3 months, prenotification or postnotification at 6 months, and a postnotification or no notification at 12-month follow-up. Unadjusted and adjusted questionnaire return rates and time to return were compared. RESULTS: The two trials comparing prenotification or postnotification with no notification at 3- and 9-month follow-up found no evidence of an effect on questionnaire response rates (3-month response rate: 82.9% vs. 84.7% (difference 1.79%, 95% confidence interval [CI] -4.53% to 8.11%, P = 0.58); 9-month response rate: 77.1% vs. 78.5% (difference = -1.44%, 95% CI -8.56% to 5.67%, P = 0.69). For the trial at 6-month follow-up, there was a statistically significant difference in response rates for postnotification (83.2%) compared with prenotification (75.2%), (difference 7.95%, 95% CI 1.00% to 14.91%, P = 0.02). CONCLUSION: SMS as a prenotification device seems ineffective. For postnotification, the evidence is unclear.

A randomized trial comparing a group exercise programme for back pain patients with individual physiotherapy in a severely deprived area.

PURPOSE: To compare a group exercise programme known as the Back to Fitness programme with individual physiotherapy for patients with non-specific low back pain from a materially deprived area. METHOD: This was a randomized controlled trial including 237 physiotherapy patients with back pain lasting more than six weeks. Participants were allocated to either the Back to Fitness programme or to individual physiotherapy, and followed up at three months and 12 months after randomization. The main outcome measure was the Roland Disability Questionnaire. Secondary measures were: SF12, EQ5D, Pain Self-Efficacy Scale. Health care diaries recording patients' use of health care resources were also collected over a 12-month period. RESULTS: There were no statistically significant differences in change scores between groups on the primary outcome measure at three months (CI - 2.24 to 0.49) and at 12 months (CI - 1.68 to 1.39). Only minor improvements in disability scores were observed in the Back to Fitness group at three months and 12 months respectively (mean change scores; - 0.89, - 0.77) and in the individual physiotherapy arm (mean change scores; - 0.02, - 0.63). Further analysis showed that patients from the most severely deprived areas were marginally worse at three month follow-up whereas those from more affluent areas tended to improve (CI 0.43 to 3.15).

Practitioner perspectives on strategies to promote longer-term benefits of acupuncture or counselling for depression: a qualitative study.

BACKGROUND: Non-pharmacological interventions for depression may help patients manage their condition. Evidence from a recent large-scale trial (ACUDep) suggests that acupuncture and counselling can provide longer-term benefits for many patients with depression. This paper describes the strategies practitioners reported using to promote longer-term benefits for their patients. METHODS: A qualitative sub-study of practitioners (acupuncturists and counsellors) embedded in a randomised controlled trial. Using topic guides, data was collected from telephone interviews and a focus group, altogether involving 19 counsellors and 17 acupuncturists. Data were audio recorded, transcribed verbatim and analysed using thematic content analysis. RESULTS: For longer-term impact, both acupuncturists and counsellors encouraged insight into root causes of depression on an individual basis and saw small incremental changes as precursors to sustained benefit. Acupuncturists stressed the importance of addressing concurrent physical symptoms, for example helping patients relax or sleep better in order to be more receptive to change, and highlighted the importance of Chinese medicine theory-based lifestyle change for lasting benefit. Counsellors more often highlighted the importance of the therapeutic relationship, emphasising the need for careful "pacing" such that the process and tools employed were tailored and timed for each individual, depending on the "readiness" to change. Our data is limited to acupuncture practitioners using the principles of traditional Chinese medicine, and counsellors using a humanistic, non-directive and person-centred approach. CONCLUSIONS: Long-term change appears to be an important focus within the practices of both acupuncturists and counsellors. To achieve this, practitioners stressed the need for an individualised approach with a focus on root causes.

Cost-effectiveness analysis of acupuncture, counselling and usual care in treating patients with depression: the results of the ACUDep trial.

BACKGROUND: New evidence on the clinical effectiveness of acupuncture plus usual care (acupuncture) and counselling plus usual care (counselling) for patients with depression suggests the need to investigate the health-related quality of life and costs of these treatments to understand whether they should be considered a good use of limited health resources. METHODS AND FINDINGS: The cost-effectiveness analyses are based on the Acupuncture, Counselling or Usual care for Depression (ACUDep) trial results. Statistical analyses demonstrate a difference in mean quality adjusted life years (QALYs) and suggest differences in mean costs which are mainly due to the price of the interventions. Probabilistic sensitivity analysis is used to express decision uncertainty. Acupuncture and counselling are found to have higher mean QALYs and costs than usual care. In the base case analysis acupuncture has an incremental cost-effectiveness ratio (ICER) of £4,560 per additional QALY and is cost-effective with a probability of 0.62 at a cost-effectiveness threshold of £20,000 per QALY. Counselling compared with acupuncture is more effective and more costly with an ICER of £71,757 and a probability of being cost-effective of 0.36. A scenario analysis of counselling versus usual care, excluding acupuncture as a comparator, results in an ICER of £7,935 and a probability of 0.91. CONCLUSIONS: Acupuncture is cost-effective compared with counselling or usual care alone, although the ranking of counselling and acupuncture depends on the relative cost of delivering these interventions. For patients in whom acupuncture is unavailable or perhaps inappropriate, counselling has an ICER less than most cost-effectiveness thresholds. However, further research is needed to determine the most cost-effective treatment pathways for depressed patients when the full range of available interventions is considered.

Copper bracelets and magnetic wrist straps for rheumatoid arthritis--analgesic and anti-inflammatory effects: a randomised double-blind placebo controlled crossover trial.

BACKGROUND: Folklore remedies for pain and inflammation in rheumatoid arthritis include the application of magnets and copper to the skin. Despite the popular use of devices containing magnets or copper for this purpose, little research has been conducted to evaluate the efficacy of such treatments. OBJECTIVE: To investigate whether the practice of wearing magnetic wrists straps, or copper bracelets, offers any specific therapeutic benefit for patients with rheumatoid arthritis. DESIGN: Randomised double-blind placebo-controlled crossover trial. METHODS: 70 patients, aged 33 to 79 years and predominantly female (n = 52), with painful rheumatoid arthritis were recruited from general practices within Yorkshire. Participants were randomly allocated to wear four devices in a different order. Devices tested were: a standard (1502 to 2365 gauss) magnetic wrist strap, a demagnetised (<20 gauss) wrist strap, an attenuated (250 to 350 gauss) magnetic wrist strap, and a copper bracelet. Devices were each worn for five weeks, with treatment phases being separated by one week wash-out periods. The primary outcome measured was pain using a 100 mm visual analogue scale. Secondary pain measures were the McGill Pain Questionnaire and tender joint count. Inflammation was assessed using C-reactive protein and plasma viscosity blood tests and by swollen joint count. Physical function was assessed using the Health Assessment Questionnaire (Disability Index). Disease activity and medication use was also measured. RESULTS: 65 participants provided complete self-report outcome data for all devices, four participants provided partial data. Analysis of treatment outcomes did not reveal any statistically significant differences (P>0.05) between the four devices in terms of their effects on pain, inflammation, physical function, disease activity, or medication use. CONCLUSIONS: Wearing a magnetic wrist strap or a copper bracelet did not appear to have any meaningful therapeutic effect, beyond that of a placebo, for alleviating symptoms and combating disease activity in rheumatoid arthritis. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN51459023 ISRCTN51459023.

Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial.

BACKGROUND: Chronic neck pain is a common condition in the adult population. More research is needed to evaluate interventions aiming to facilitate beneficial long-term change. We propose to evaluate the effect of Alexander Technique lessons and acupuncture in a rigorously conducted pragmatic trial with an embedded qualitative study. METHODS/DESIGN: We will recruit 500 patients who have been diagnosed with neck pain in primary care, who have continued to experience neck pain for at least three months with 28% minimum cut-off score on the Northwick Park Neck Pain Questionnaire (NPQ). We will exclude patients with serious underlying pathology, prior cervical spine surgery, history of psychosis, rheumatoid arthritis, ankylosing spondylitis, osteoporosis, haemophilia, cancer, HIV or hepatitis, or with alcohol or drug dependency currently or in the last 12 months, or actively pursuing compensation or with pending litigation.The York Trials Unit will randomly allocate participants using a secure computer-based system. We will use block randomisation with allocation to each intervention arm being unambiguously concealed from anyone who might subvert the randomisation process.Participants will be randomised in equal proportions to Alexander Technique lessons, acupuncture or usual care alone. Twenty 30-minute Alexander Technique lessons will be provided by teachers registered with the Society of Teachers of the Alexander Technique and twelve 50-minute sessions of acupuncture will be provided by acupuncturists registered with the British Acupuncture Council. All participants will continue to receive usual GP care.The primary outcome will be the NPQ at 12 months, with the secondary time point at 6 months, and an area-under-curve analysis will include 3, 6 and 12 month time-points. Adverse events will be documented. Potential intervention effect modifiers and mediators to be explored include: self-efficacy, stress management, and the incorporation of practitioner advice about self-care and lifestyle. Qualitative material will be used to address issues of safety, acceptability and factors that impact on longer term outcomes. DISCUSSION: This study will provide robust evidence on whether there are significant clinical benefits to patients, economic benefits demonstrating value for money, and sufficient levels of acceptability and safety. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15186354.

Acupuncture, Counseling, and Usual care for Depression (ACUDep): study protocol for a randomized controlled trial.

BACKGROUND: The evidence on the effect of acupuncture or counseling for depression is not conclusive yet is sufficient to warrant further research. Our aim is to conduct a full-scale RCT to determine the clinical and cost effectiveness of acupuncture and counseling compared to usual care alone. We will explore the experiences and perspectives of patients and practitioners. METHODS/DESIGN: Randomized controlled trial with three parallel arms: acupuncture plus usual care, counseling plus usual care, and usual care alone, in conjunction with a nested qualitative study using in-depth interviews with purposive samples of trial participants. PARTICIPANTS: Patients aged over 18 years diagnosed with depression or mood disorder by their GP and with a score of 20 or above on the Beck Depression Inventory (BDI-II).Randomization: Computer randomization by York Trials Unit to acupuncture, counseling, and usual care alone in proportions of 2:2:1, respectively, with secure allocation concealment. INTERVENTIONS: Patients allocated to acupuncture and counseling groups receive the offer of up to 12 weekly sessions. Both interventions allow flexibility to address patient variation, yet are constrained within defined protocols. Acupuncture is based on traditional Chinese medicine and counseling is non-directive within the humanistic tradition. OUTCOME: The PHQ-9 is the primary outcome measure, collected at baseline, 3, 6, 9, and 12 months. Also measured is BDI-II, SF-36 Bodily pain subscale, and EQ-5D. Texted mood scores are collected weekly over the first 15 weeks. Health-related resource use is collected over 12 months. ANALYSIS: The sample size target was for 640 participants, calculated for an effect size of 0.32 on the PHQ-9 when comparing acupuncture with counseling given 90% power, 5% significance, and 20% loss to follow-up. ANALYSIS of covariance will be used on an intention-to-treat basis. Thematic analysis will be used for qualitative data. We will compare incremental cost-effectiveness of the three treatment options at 12 months. DISCUSSION: Ethical approval was obtained in October 2009. There were six subsequent protocol amendments, the last of which was approved in January 2012. Recruitment of 755 participants took place over 18 months. Data collection will be completed by June 2012. No interim analyses have been conducted. TRIAL REGISTRATION: ISRCTN63787732.

Therapeutic effects of magnetic and copper bracelets in osteoarthritis: a randomised placebo-controlled crossover trial.

OBJECTIVES: To test the effectiveness of a typical magnetic wrist strap for reducing pain and stiffness, and for improving physical functioning amongst patients with osteoarthritis. DESIGN: A randomised double-blind placebo-controlled crossover trial. Each participant wore four devices over a 16-week period. SETTING: Forty five patients with osteoarthritis were recruited from general practices in rural and urban areas of Yorkshire. INTERVENTIONS: Experimental device: a commercially available magnetic wrist strap. Control devices: a weak magnetic wrist strap, a demagnetised wrist strap, and a copper bracelet. MAIN OUTCOME MEASURES: The WOMAC Osteoarthritis Index, the McGill Pain Questionnaire-Pain Rating Index (PRI), a pain visual analogue scale (VAS), and medication use. RESULTS: No difference was observed between devices in terms of their effects on pain as measured by the primary outcome measure (WOMAC A), the PRI and the VAS. Similar results were obtained for stiffness (WOMAC B), physical function (WOMAC C), and medication use. Further analyses of the PRI subscales revealed a statistically significant difference between devices (P=0.025), which favoured the experimental device. Participants reported lower sensory pain after wearing the standard magnetic wrist strap, than when wearing control devices. However, no adjustment was made for multiple testing. CONCLUSIONS: Our results indicate that magnetic and copper bracelets are generally ineffective for managing pain, stiffness and physical function in osteoarthritis. Reported therapeutic benefits are most likely attributable to non-specific placebo effects. However such devices have no major adverse effects and may provide hope.

Magnet therapy for the relief of pain and inflammation in rheumatoid arthritis (CAMBRA): a randomised placebo-controlled crossover trial.

BACKGROUND: Rheumatoid arthritis is a common inflammatory autoimmune disease. Although disease activity may be managed effectively with prescription drugs, unproven treatments such as magnet therapy are sometimes used as an adjunct for pain control. Therapeutic devices incorporating permanent magnets are widely available and easy to use. Magnets may also be perceived as a more natural and less harmful alternative to analgesic compounds. Of interest to health service researchers is the possibility that magnet therapy might help to reduce the economic burden of managing chronic musculoskeletal disorders. Magnets are extremely cheap to manufacture and prolonged treatment involves a single cost. Despite this, good quality scientific evidence concerning the safety, effectiveness and cost-effectiveness of magnet therapy is scarce. The primary aim of the CAMBRA trial is to investigate the effectiveness of magnet therapy for relieving pain and inflammation in rheumatoid arthritis. METHODS/DESIGN: The CAMBRA trial employs a randomised double-blind placebo-controlled crossover design. Participant will each wear four devices: a commercially available magnetic wrist strap; an attenuated wrist strap; a demagnetised wrist strap; and a copper bracelet. Device will be allocated in a randomised sequence and each worn for five weeks. The four treatment phases will be separated by wash out periods lasting one week. Both participants and researchers will be blind, as far as feasible, to the allocation of experimental and control devices. In total 69 participants will be recruited from general practices within the UK. Eligible patients will have a verified diagnosis of rheumatoid arthritis that is being managed using drugs, and will be experiencing chronic pain. Outcomes measured will include pain, inflammation, disease activity, physical function, medication use, affect, and health related costs. Data will be collected using questionnaires, diaries, manual pill counts and blood tests. DISCUSSION: Magnetism is an inherent property of experimental devices which is hard to conceal. The use of multiple control devices, including a copper bracelet, represents a concerted attempt to overcome methodological limitations associated with trials in this field. The trial began in July 2007. At the time of submission (August 2008) recruitment has finished, with 70 trial participants, and data collection is almost complete. TRIAL REGISTRATION: Current Controlled Trials ISRCTN51459023.

A systematic evaluation of the impact of STRICTA and CONSORT recommendations on quality of reporting for acupuncture trials.

BACKGROUND: We investigated whether there had been an improvement in quality of reporting for randomised controlled trials of acupuncture since the publication of the STRICTA and CONSORT statements. We conducted a before-and-after study, comparing ratings for quality of reporting following the publication of both STRICTA and CONSORT recommendations. METHODOLOGY AND PRINCIPAL FINDINGS: Ninety peer reviewed journal articles reporting the results of acupuncture trials were selected at random from a wider sample frame of 266 papers. Papers published in three distinct time periods (1994-1995, 1999-2000 and 2004-2005) were compared. Assessment criteria were developed directly from CONSORT and STRICTA checklists. Papers were independently assessed for quality of reporting by two assessors, one of whom was blind to information which could have introduced systematic bias (e.g. date of publication). We detected a statistically significant increase in the reporting of CONSORT items for papers published in each time period measured. We did not, however, find a difference between the number of STRICTA items reported in journal articles published before and 3 to 4 years following the introduction of STRICTA recommendations. CONCLUSIONS AND SIGNIFICANCE: The results of this study suggest that general standards of reporting for acupuncture trials have significantly improved since the introduction of the CONSORT statement in 1996, but that quality in reporting details specific to acupuncture interventions has yet to change following the more recent introduction of STRICTA recommendations. Wider targeting and revision of the guidelines is recommended.

Randomized trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: cost-effectiveness analysis.

OBJECTIVES: To assess the cost-effectiveness of brief physiotherapy intervention versus usual physiotherapy management in patients with neck pain of musculoskeletal origin in the community setting. METHODS: A cost-effectiveness analysis was conducted alongside a multicenter pragmatic randomized controlled clinical trial. Individuals 18 years of age and older with neck pain of more than 2 weeks were recruited from physiotherapy departments with referrals from general practitioners (GPs) in the East Yorkshire and North Lincolnshire regions in the United Kingdom. A total of 139 patients were allocated to the brief intervention, and 129 to the usual physiotherapy. Resource use data were prospectively collected on the number of physiotherapy sessions, hospital stay, specialist, and GP visits. Quality-adjusted life years (QALYs) were estimated using EQ-5D data collected at baseline, 3 and 12 months from the start of the treatment. The economic evaluation was conducted from the U.K. National Health System perspective. RESULTS: On average, brief intervention produced lower costs (pounds--68; 95 percent confidence interval [CI], pounds--103 to pounds--35) and marginally lower QALYs (-0.001; 95 percent CI, -0.030 to 0.028) compared with usual physiotherapy, resulting in an incremental cost per QALY of pounds 68,000 for usual physiotherapy. These results are sensitive to patients' treatment preferences. CONCLUSIONS: Usual physiotherapy may not be good value for money for the average individual in this trial but could be a cost-effective strategy for those who are indifferent toward which treatment they receive.

Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference.

OBJECTIVES: Firstly, to compare the effectiveness of a brief physiotherapy intervention with "usual" physiotherapy for patients with neck pain. Secondly, to evaluate the effect of patients' preferences on outcome. DESIGN: Non-inferiority randomised controlled trial eliciting preferences independently of randomisation. SETTING: Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire. PARTICIPANTS: 268 patients (mean age 48 years) with subacute and chronic neck pain, who were referred by their general practitioner and randomly assigned to a brief physiotherapy intervention (one to three sessions) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy, at the discretion of the physiotherapist concerned. MAIN OUTCOME MEASURES: The Northwick Park neck pain questionnaire (NPQ), a specific measure of functional disability resulting from neck pain. Also, the short form 36 (SF-36) questionnaire, a generic, health related, quality of life measure; and the Tampa scale for kinesophobia, a measure of fear and avoidance of movement. RESULTS: At 12 months, patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group (mean difference 1.99, 95% confidence interval 0.45 to 3.52; P = 0.01). Although the result shows a significant inferiority of the intervention, the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention (below 1.2 points of NPQ score). Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy. CONCLUSIONS: Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain. Patients with a preference for the brief intervention may do at least as well with this approach. Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further.