Abstract
Background: Low back pain is an extremely common health problem, and is associated with significant economic and social impact. Acupuncture is one of the most frequently sought complementary and alternative medicine modalities for treating low back pain. This thesis investigated the effectiveness of acupuncture in the management of low back pain, with a focus on one aspect of dosage, i.e. number of treatment sessions.
Methods: This thesis took a systematic, step-wise, pragmatic approach to address the research question. The United Kingdom Medical Research Council guidelines for developing and evaluating complex interventions provided the framework for the thesis development. Emphasis was placed on the development and feasibility phases of the research process. In the development phase, an overview of systematic reviews was conducted to evaluate evidence for the effectiveness of acupuncture for low back pain; and a review of the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines was performed to explore strategies to improve on the reporting quality of acupuncture research. In the feasibility phase, a randomized controlled feasibility trial was conducted to test the feasibility for conducting a fully powered randomized controlled trial investigating the optimal number of sessions of acupuncture (4, 7 or 10 sessions) used as an adjunct to usual care, for the management of chronic low back pain in adults.
Results: Evidence from the overview of systematic reviews suggested that acupuncture is an effective treatment option for patients with chronic low back pain. When compared with no treatment, or used as an adjunct to conventional care, acupuncture provided significant clinical benefits including pain relief and functional improvement at short-term follow-up. In order to improve clinical effectiveness of acupuncture, future research may evaluate the dose response of acupuncture (e.g. number of treatment sessions) in this area. It was demonstrated that STRICTA is a valid reporting guideline based on robust methodology and scientific content. However specific implementation strategies are needed for improvement in the efficacy of the STRICTA, which may serve to promote the reporting quality and reliability of acupuncture research including: updating the STRICTA checklist; improving the STRICTA reporting efficiency; implementing the ‘Instructions to authors’ for journals consistently; establishing STRICTA research centres globally; and expanding the STRICTA website. Results from the feasibility study supported the feasibility of carrying out a definitive randomized controlled trial comparing outcomes from different session numbers of acupuncture for the management of chronic low back pain. 45 participants were recruited within 10 weeks (recruitment rate of 43.7%), and agreed to be randomized. Acupuncture was demonstrated to be acceptable among participants, and high retention rates (86.7%, 86.7%, 100% for the 4, 7, 10 sessions groups, respectively) were recorded. Over 80% of participants indicated that they were ‘very satisfied’ and/or ‘extremely satisfied’ with acupuncture. Participant follow-up rates were 88.9% at discharge (Q1) and at six weeks post randomization (Q2), and 84.4% at 12 weeks post randomization (Q3).
Conclusions: The current thesis has provided evidence to add to the scientific basis underpinning the therapeutic value of acupuncture for LBP. From the overview of systematic reviews, acupuncture, either used in isolation or as an adjunct to conventional therapy, has been demonstrated as an effective clinical option for patients with chronic LBP. The need for improvements in the external validity of acupuncture research has been highlighted by the findings of the overview; potential options to improve on such reporting have been discussed surrounding the specific strategies for improving the efficacy of the STRICTA guidelines. There is currently limited evidence available regarding the dose dependence of acupuncture for chronic LBP based on the number of sessions. Collectively, results from the feasibility study supported the decision to proceed to a full-scale randomized controlled trial to definitively test the dose response effects of acupuncture, and investigate the optimal number of sessions of acupuncture for the management of chronic low back pain. Findings may assist with the development of future clinical guidelines regarding the dosage of acupuncture treatment in routine practice, a point of clinical relevance to clinicians, researchers, and policy makers.