269086 Adverse events among seniors receiving spinal manipulation and exercise in a clinical trial

Monday, October 29, 2012 : 3:30 PM - 3:45 PM

Michele Maiers, DC, MPH , Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, MN
Gert Bronfort, DC, PhD , Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, MN
Roni Evans, MS, DC , Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, MN
Craig Schulz, DC, MS , Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, MN
     
Background: Adverse events (AEs) associated with spinal manipulative therapy and exercise are common, but generally mild in intensity and duration. Their occurrence in an elderly population is less well understood.

Methods: AEs were collected as part of an IRB-approved randomized clinical trial of chronic neck pain in seniors > 65 years old. Participants were assigned to receive spinal manipulation plus home exercise (SMT+HE), supervised rehabilitative exercise plus home exercise (SRE+HE), or home exercise alone (HE). At the beginning of each treatment visit, participants were asked if they experienced any “side effects or problems since the last visit”. Affirmative answers were probed for detail. A descriptive analysis was conducted on all responses determined to be potentially associated with treatment.

Results: Data was collected from 194 of 241 consecutively enrolled study participants (SMT+HE =78, SRE+HE=59, HE=57). Non-serious, expected AEs were reported by 44 individuals (56%) in SMT+HE, 53 (90%) in SRE+HE, and 33 (58%) in the HE group. Most common AEs in all three groups included an aggravation of neck symptoms, muscle soreness, lower and upper extremity joint pain, back pain, and stiffness. One unexpected AE related to treatment was reported in the SRE+HE group: a participant fell and fractured his radius while performing study related exercises during a supervised visit.

Conclusion: Many of the seniors in this study experienced non-serious, expected AEs, particularly in the combined SRE+HE group. Of interest, many seniors reported an aggravation of extremity joint pain with prescribed exercises in these programs.

Learning Areas:
Provision of health care to the public
Public health or related research

Learning Objectives:
Describe adverse events associated with spinal manipulation and exercise among seniors participating in a randomized clinical trial.

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I was a co-investigator on this trial, and was primarily responsible for the analysis and interpretation of this data.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

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