title: Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial.
abstract: Spinal manipulative therapy (SMT) and exercise have demonstrated effectiveness for neck pain (NP). Adverse events (AE) reporting in trials, particularly among elderly participants, is inconsistent and challenges informed clinical decision making. This paper provides a detailed report of AE experienced by elderly participants in a randomized comparative effectiveness trial of SMT and exercise for chronic NP. AE data, consistent with CONSORT recommendations, were collected on elderly participants who received 12 weeks of SMT with home exercise, supervised plus home exercise, or home exercise alone. Standardized questions were asked at each treatment; participants were additionally encouraged to report AE as they occurred. Qualitative interviews documented participants' experiences with AE. Descriptive statistics and content analysis were used to categorize and report these data. Compliance was high among the 241 randomized participants. Non-serious AE were reported by 130/194 participants. AE were reported by three times as many participants in supervised plus home exercise, and nearly twice as many as in SMT with home exercise, as in home exercise alone. The majority of AE were musculoskeletal in nature; several participants associated AE with specific exercises. One incapacitating AE occurred when a participant fell during supervised exercise session and fractured their arm. One serious adverse event of unknown relationship occurred to an individual who died from an aneurysm while at home. Eight serious, non-related AE also occurred. Musculoskeletal AE were common among elderly participants receiving SMT and exercise interventions for NP. As such, they should be expected and discussed when developing care plans.
authors.affiliation: Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN 55431, USA. Electronic address: mmaiers@nwhealth.edu.
authors.forename: Michele
authors.initials: M
authors.lastname: Maiers
authors.affiliation: Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN 55431, USA.
authors.forename: Roni
authors.initials: R
authors.lastname: Evans
authors.affiliation: University of Southern Denmark, Campusvej 55, DK-5230 Odense M, Denmark.
authors.forename: Jan
authors.initials: J
authors.lastname: Hartvigsen
authors.affiliation: Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN 55431, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Schulz
authors.affiliation: Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, 2501 W 84th Street, Bloomington, MN 55431, USA.
authors.forename: Gert
authors.initials: G
authors.lastname: Bronfort
mesh_terms: D000367:Age Factors; D000368:Aged; D059350:Chronic Pain / Q000175:diagnosis / Q000628:therapy*; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D015577:Geriatric Assessment; D006801:Humans; D008297:Male; D020393:Manipulation, Spinal / Q000009:adverse effects* / Q000379:methods; D019547:Neck Pain / Q000175:diagnosis / Q000628:therapy*; D010147:Pain Measurement; D018570:Risk Assessment; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
keywords: Adverse events; Elderly; Exercise; Spinal manipulation