Abstract
BackgroundThe 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.MethodsParticipants 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.ResultsOn 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 < 0.0001] and an 11% reduction in pain-related disability measured by the Million Visual Analog Scale [MVAS: F(1, 84) = 28.3, P < 0.0001] from baseline to the end of treatment, but no one treatment performed better than the other, and the reductions in pain and pain-related disability were largely lost by 1-month follow-up. Symptoms of PTSD and depression did not change significantly as a function of time or group.ConclusionsFindings build on previous work suggesting that traditional Chinese acupuncture and TENS can reduce pain and its functional sequelae without risks associated with pharmacological pain management. The Tennant Biomodulator used on its most basic setting performs as well as these other interventions. Based on the present findings, large, randomized controlled trials on the Tennant Biomodulator are indicated. Future work should test this device using its full range of settings for pain-related psychological health.Trial registrationClincialtrials.gov (NCT01752010); registered December 14, 2012.
Highlights
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
In light of the enormous personal and public health burden of chronic pain and the current opioid crisis in the United States, the present investigation sought to test the efficacy of the Tennant Biomodulator, an accessible and scalable pain management intervention with a minimal side-effect profile and few contraindications
The Tennant Biomodulator may have value as a nonpharmacological pain and associated symptom management solution because the present findings suggest it is as efficacious as acupuncture or transcutaneous electrical nerve stimulation (TENS), it addresses several of the limitations of basic TENS units, and unlike acupuncture, it does not require access to health care providers
Summary
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. Opioidbased pain medications involve a risk for the development of opioid use disorder. In light of these limitations, as well as the current opioid crisis largely attributed to the over-prescription of opioid medications for pain management [3] and the enormous personal and public health burden of chronic pain, there is a pressing need for non-pharmacological, accessible, and scalable pain management interventions. Veterans are thought to be disproportionately affected by substance use disorders arising from pain medication prescriptions and attempts to self-manage pain with alcohol and other drugs [9]
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