a parallel-group randomized clinical trial evaluating relative effectiveness and harms
BACKGROUND: Back and neck disability are frequent in older adults resulting in loss of function and independence. Exercise therapy and manual therapy, like spinal manipulative therapy (SMT), have evidence of short and intermediate term effectiveness for spinal disability in the general population and growing evidence in older adults. For older populations experiencing chronic spinal conditions, long term management may be more appropriate to maintain improvement and minimize the impact of future exacerbations. Research is limited comparing short courses of treatment to long term management of spinal disability. The primary aim is to compare the relative effectiveness of 12 weeks versus 36 weeks of SMT and supervised rehabilitative exercise (SRE) in older adults with back and neck disability. METHODS/DESIGN: Randomized, mixed-methods, comparative effectiveness trial conducted at a university-affiliated research clinic in the Minneapolis/St. Paul, Minnesota metropolitan area. PARTICIPANTS: Independently ambulatory community dwelling adults ≥ 65 years of age with back and neck disability of minimum 12 weeks duration (n = 200). INTERVENTIONS: 12 weeks SMT + SRE or 36 weeks SMT + SRE. RANDOMIZATION: Blocked 1:1 allocation; computer generated scheme, concealed in sequentially numbered, opaque, sealed envelopes. BLINDING: Functional outcome examiners are blinded to treatment allocation; physical nature of the treatments prevents blinding of participants and providers to treatment assignment. PRIMARY ENDPOINT: 36 weeks post-randomization. DATA COLLECTION: Self-report questionnaires administered at 2 baseline visits and 4, 12, 24, 36, 52, and 78 weeks post-randomization. Primary outcomes include back and neck disability, measured by the Oswestry Disability Index and Neck Disability Index. Secondary outcomes include pain, general health status, improvement, self-efficacy, kinesiophobia, satisfaction, and medication use. Functional outcome assessment occurs at baseline and week 37 for hand grip strength, short physical performance battery, and accelerometry. Individual qualitative interviews are conducted when treatment ends. Data on expectations, falls, side effects, and adverse events are systematically collected. PRIMARY ANALYSIS: Linear mixed-model method for repeated measures to test for between-group differences with baseline values as covariates. DISCUSSION: Treatments that address the management of spinal disability in older adults may have far reaching implications for patient outcomes, clinical guidelines, and healthcare policy. TRIAL REGISTRY: www.ClinicalTrials.gov; Identifier: NCT01057706.