A randomized trial comparing the Tennant Biomodulator to transcutaneous electrical nerve stimulation and traditional Chinese acupuncture for the treatment of chronic pain in military service members

Abstract Background The present investigation tested the efficacy of the Tennant Biomodulator, a novel pain management intervention that uses biofeedback-modulated electrical stimulation, to reduce chronic pain and its psychosocial sequelae in a sample of current and former military service members. The Tennant Biomodulator used on its most basic setting was compared to two commonly used, non-pharmacological pain treatments—traditional Chinese acupuncture and transcutaneous electrical nerve stimulation (TENS)—in a comparative efficacy, randomized, open-label trial. Methods Participants included 100 active duty and retired service men and women with chronic pain undergoing treatment at the Brooke Army Medical Center in Texas, USA, randomly assigned to receive six, weekly sessions of either Tennant Biomodulator treatment, traditional Chinese acupuncture, or TENS, in addition to usual care. Recruitment was conducted between May 2010 to September 2013. Outcome measures were collected at intake, before and after each treatment session, and at a 1-month follow-up. Intent-to-treat analyses were used throughout, with mixed models used to investigate main effects of group, time, and group × time interactions with consideration given to quadratic effects. Outcomes measured included ratings of chronic pain, pain-related functional disability, and symptoms of post-traumatic stress disorder (PTSD) and depression. Results On average, regardless of their treatment group, participants exhibited a 16% reduction in pain measured by the Brooke Army Medical Center’s Clinic Pain Log [F(1, 335) = 55.7, P