Abstract
BackgroundStudies have shown that physical interventions and psychological methods based on the cognitive behavioral approach are efficacious in alleviating pain and that combining both tends to yield more benefits than either intervention alone. In view of the aging population with chronic pain and the lack of evidence-based pain management programs locally, we developed a multicomponent intervention incorporating physical exercise and cognitive behavioral techniques and examined its long-term effects against treatment as usual (i.e., pain education) in older adults with chronic musculoskeletal pain in Hong Kong.Methods/designWe are conducting a double-blind, cluster-randomized controlled trial. A sample of 160 participants aged ≥ 60 years will be recruited from social centers or outpatient clinics and will be randomized on the basis of center/clinic to either the multicomponent intervention or the pain education program. Both interventions consist of ten weekly sessions of 90 minutes each. The primary outcome is pain intensity, and the secondary outcomes include pain interference, pain persistence, pain self-efficacy, pain coping, pain catastrophizing cognitions, health-related quality of life, depressive symptoms, and hip and knee muscle strength. All outcome measures will be collected at baseline, postintervention, and at 3 and 6 months follow-up. Intention-to-treat analysis will be performed using mixed-effects regression to see whether the multicomponent intervention alleviates pain intensity and associated outcomes over and above the effects of pain education (i.e., a treatment × time intervention effect).DiscussionBecause the activities included in the multicomponent intervention were carefully selected for ready implementation by allied health professionals in general, the results of this study, if positive, will make available an efficacious, nonpharmacological pain management program that can be widely adopted in clinical and social service settings and will hence improve older people’s access to pain management services.Trial registrationChinese Clinical Trial Registry, ChiCTR-IIR-16008387. Registered on 28 April 2016.
Highlights
Studies have shown that physical interventions and psychological methods based on the cognitive behavioral approach are efficacious in alleviating pain and that combining both tends to yield more benefits than either intervention alone
Because the activities included in the multicomponent intervention were carefully selected for ready implementation by allied health professionals in general, the results of this study, if positive, will make available an efficacious, nonpharmacological pain management program that can be widely adopted in clinical and social service settings and will improve older people’s access to pain management services
Study objectives and design In a cluster-randomized controlled trial with two arms, we aim to evaluate the long-term effects of a newly developed multicomponent pain management intervention incorporating physical exercise and cognitive behavioral techniques against a pain education program in older adults
Summary
There will be more and more older people with chronic musculoskeletal pain that cannot be managed by pharmacological treatment alone. Evidencebased nonpharmacological interventions are very much needed Such interventions are preferably designed in such a way that they are deliverable by a range of healthcare workers in different settings to improve access to pain management services, especially in places such as Hong Kong, where specialist manpower is very tight or lacking. The present multicomponent intervention was designed according to these principles and considerations, on the basis of existing evidence and guidelines about the use of physical exercise and cognitive behavioral techniques for the management of pain. This intervention is being subjected to an evaluation against a pain education program in a double-blind, cluster-randomized controlled trial. As of 14 April 2017, we had recruited 136 participants
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