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.

Author: Peacock KS1, Stoerkel E2, Libretto S3, Zhang W4, Inman A5, Schlicher M6, Cowsar JD Jr7, Eddie D8, Walter J9
Affiliation:
1University of Texas Health San Antonio, 7703 Floyd Curl Drive, San Antonio, TX, 78229, USA.
2TLI Foundation, 1750 Tysons Boulevard, McLean, Virginia, 22102, USA.
3Henry M. Jackson Foundation, 6720A Rockledge Drive, Bethesda, MD, 20817, USA.
4BD Life Sciences, 1 Becton Drive, Franklin Lakes, NJ, 07417, USA.
5Brooke Army Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, TX, 78234, USA.
6Madigan Army Medical Center, 9040A Jackson Ave, Joint Base Lewis-McChord, WA, 98431, USA.
7MedPost Urgent Care Center, 513 Cibolo Valley Drive, Cibolo, TX, 78108, USA.
8Massachusetts General Hospital, Harvard Medical School, 151 Merrimac St. 6th Floor, Boston, MA, 02114, USA. deddie@mgh.harvard.edu.
9H&S Ventures, Samueli Integrative Health Program, 1800 Diagonal Road, Suite 617, Alexandria, VA, 22314, USA.
Conference/Journal: Mil Med Res.
Date published: 2019 Dec 2
Other: Volume ID: 6 , Issue ID: 1 , Pages: 37 , Special Notes: doi: 10.1186/s40779-019-0227-4. , Word Count: 378


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 <  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.

CONCLUSIONS: Findings 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 REGISTRATION: Clincialtrials.gov (NCT01752010); registered December 14, 2012.

KEYWORDS: Acupuncture; Chronic pain; Military service members; Tennant biomodulator; Transcutaneous electrical nerve stimulation

PMID: 31791416 DOI: 10.1186/s40779-019-0227-4

BACK