Abstract
BackgroundChronic 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/DesignWe 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.DiscussionThis 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 registrationCurrent Controlled Trials ISRCTN15186354
Highlights
Chronic neck pain is a common condition in the adult population
We will compare the cost-effectiveness of the alternative strategies, and if these interventions are at an additional cost to usual care, we will ascertain whether they are worth paying for in terms of cost per Quality Adjusted Life Year (QALY) gained, in the context of the National Institute for Health and Care Excellence (NICE) threshold, which ranges from £20,000 to £30,000 [5]
All intervention sites involved in the trial obtained ‘site specific approval’ from the National health service (NHS) research ethics committee
Summary
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. Many people with chronic neck pain consult acupuncturists and Alexander Technique teachers, largely outside the NHS, and while these interventions are considered relatively safe, the evidence on health outcomes is as yet inconclusive [1]. The principal research questions to be addressed Our principal research question asks: What is the clinical and economic impact when comparing acupuncture treatment plus usual care to usual care alone, and Alexander Technique lessons plus usual care to usual care alone in patients with chronic neck pain who are recruited from primary care? We will compare acupuncture to Alexander Technique lessons to estimate possible clinical differences. We have used our pilot trial on acupuncture for chronic neck pain (ISRCTN06223266) [6] to inform the design of the full-scale trial
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