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Adverse events experienced by participants in a back pain walking intervention: A descriptive study
Sarah L Krein1, Yousef Abdul-Wahab2, Reema Kadri3
1VA Ann Arbor Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, USA Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, USA skrein@umich.edu.
Objective:
To understand the range and potential severity of adverse events reported by patients with back pain who were participating in a walking intervention.
Methods:
Data were obtained from participants in a randomized trial of a pedometer-based Internet-mediated intervention to promote walking and reduce back pain-related disability (n = 229 participants, 118 usual care, and 111 intervention). Participants reported adverse events throughout the 12-month study period. All reported events were reviewed and classified by system, severity, and study relatedness.
Results:
A total of 600 adverse events were reported, 250 by those in usual care and nearly 350 by those in the intervention. After worsening back pain (27%), musculoskeletal events were the most commonly reported events (19%), followed by cardiovascular events (14%), infection (11%), and medical procedures (9%). There were three times as many musculoskeletal events in the intervention compared to the usual care group. Cardiovascular events, which were generally not serious and not walking related, were far less common than musculoskeletal injuries.
Conclusions:
Individuals with chronic back pain can safely engage in a pedometer-based, unsupervised walking program. However, patients may benefit from focused counseling about musculoskeletal risks with specific attention to injury prevention measures such as gradually incrementing activity levels.
