title: Short term treatment versus long term management of neck and back disability in older adults utilizing spinal manipulative therapy and supervised exercise: a parallel-group randomized clinical trial evaluating relative effectiveness and harms.
abstract: 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
  Randomized, mixed-methods, comparative effectiveness trial conducted at a university-affiliated research clinic in the Minneapolis/St. Paul, Minnesota metropolitan area.
  
  
  METHODS
  Independently ambulatory community dwelling adults ≥ 65 years of age with back and neck disability of minimum 12 weeks duration (n = 200).
  
  
  METHODS
  12 weeks SMT + SRE or 36 weeks SMT + SRE.
  
  
  METHODS
  Blocked 1:1 allocation; computer generated scheme, concealed in sequentially numbered, opaque, sealed envelopes.
  
  
  METHODS
  Functional outcome examiners are blinded to treatment allocation; physical nature of the treatments prevents blinding of participants and providers to treatment assignment.
  
  
  METHODS
  36 weeks post-randomization.
  
  
  METHODS
  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.
  Linear mixed-model method for repeated measures to test for between-group differences with baseline values as covariates.
  
  
  CONCLUSIONS
  Treatments that address the management of spinal disability in older adults may have far reaching implications for patient outcomes, clinical guidelines, and healthcare policy.
  
  
  BACKGROUND
  www.ClinicalTrials.gov; Identifier: NCT01057706.
authors.affiliation: Northwestern Health Sciences University, Wolfe-Harris Center for Clinical Studies, 2501 W 84th Street, Bloomington 55431, MN, USA.
authors.forename: Corrie
authors.initials: C
authors.lastname: Vihstadt
authors.affiliation: Northwestern Health Sciences University, Wolfe-Harris Center for Clinical Studies, 2501 W 84th Street, Bloomington 55431, MN, USA.
authors.forename: Michele
authors.initials: M
authors.lastname: Maiers
authors.affiliation: Northwestern Health Sciences University, Wolfe-Harris Center for Clinical Studies, 2501 W 84th Street, Bloomington 55431, MN, USA.
authors.forename: Kristine
authors.initials: K
authors.lastname: Westrom
authors.affiliation: University of Minnesota, Center for Spirituality and Healing, Mayo Memorial Building C592, 420 Delaware Street SE, Minneapolis 55455, MN, USA.
authors.forename: Gert
authors.initials: G
authors.lastname: Bronfort
authors.affiliation: University of Minnesota, Center for Spirituality and Healing, Mayo Memorial Building C592, 420 Delaware Street SE, Minneapolis 55455, MN, USA.
authors.forename: Roni
authors.initials: R
authors.lastname: Evans
authors.affiliation: Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, Odense DK-5230, M, Denmark.
authors.forename: Jan
authors.initials: J
authors.lastname: Hartvigsen
authors.affiliation: Northwestern Health Sciences University, Wolfe-Harris Center for Clinical Studies, 2501 W 84th Street, Bloomington 55431, MN, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Schulz
keywords: Back disability; Comparative effectiveness; Exercise therapy; Mixed-methods; Neck disability; Older adults; Spinal manipulative therapy