Adverse events among seniors receiving spinal manipulation and exercise in a randomized clinical trial

Spinal manipulative therapy (SMT) and exercise have shown 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 every treatment; participants were also 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 the 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 almost 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 a person who died from an aneurysm while at home. Eight serious, non-related AE also occurred.
Musculoskeletal AE occurred frequently among elderly participants receiving SMT and exercise interventions for NP. For this reason, they should be anticipated and discussed when developing care plans.