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.

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.

Effectiveness of a Self-Care Toolkit for Surgical Breast Cancer Patients in a Military Treatment Facility.

OBJECTIVE: To assess whether a self-care toolkit (SCT) provided to breast cancer patients undergoing surgery could mitigate distress and lessen symptoms associated with surgery. DESIGN: One hundred women with breast cancer, planning to undergo initial surgery, were randomly assigned to either one of two groups: treatment as usual (TAU; n = 49) or TAU with the addition of an SCT (n = 51). The SCT contained an MP3 player with audio-files of guided mind-body techniques (breathing, progressive muscle relaxation, meditation, guided imagery, and self-hypnosis) and acupressure antinausea wristbands. Anxiety, pain, nausea, sleep, fatigue, global health, and quality of life (QOL) were assessed using validated outcome measures. Two inflammatory blood markers (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]) were measured serially. Data were collected at baseline (T1), immediately before surgery (T2), within 10 h postoperatively (T3), and ∼2 weeks postsurgery (T4). SETTINGS: Numerous studies have shown that psychological distress associated with a cancer diagnosis can affect pain perception and QOL. RESULTS: Between T1 and T4, there were significant between-group differences in Patient-Reported Outcomes Measurement Information System (PROMIS)-57 scores of Pain Interference, Fatigue, and Satisfaction with Social Roles, favoring the SCT group compared with TAU (p = 0.005, p = 0.023, and p = 0.021, respectively). There was a significant mean change in Defense and Veterans Pain Rating Scale (DVPRS) scores from T2 to T3, with the SCT group having significantly smaller increases in postoperative pain (p = 0.008) and in postoperative ESR (p = 0.0197) compared with the TAU group. Clinically significant reductions in anxiety occurred in the SCT group during the main intervention period. CONCLUSION: These results suggest that using the SCT in the perioperative period decreased pain perceptions, fatigue, and inflammatory cytokine secretion.