Clinical validation of a non-invasive electrodermal biofeedback device useful for reducing chronic perceived pain and systemic inflammation. Chrousos GP, Boschiero D.

This study was performed to evaluate the potential clinical usefulness of a new non-invasive electrodermal biofeedback device in reducing perceived pain levels and chronic systemic inflammation.

MATERIALS AND METHODS: This multicenter study was designed and coordinated by BioTekna, included 20 general practice medical centers, took place between June 2010 and January 2011, and was validated clinically at the National and Kapodistrian University of Athens, Greece. The study participants were 1015 Caucasian men (401) and women (614), while the placebo-treated controls were 950 Caucasian men (500) and women (450). Patients were aged between 30 and 86 years (average age about 50 years) and all suffered from chronic pain and other medically unexplained symptoms (MUS). The RegMatEx electrodermal biofeedback device (brand BioTekna – Biomedical Technologies, Marcon, Venice, Italy) was used to evaluate the clinical efficacy of electrodermal biofeedback in reducing the level of pain perceived by decreasing the chronic systemic inflammation of the subjects. All subjects received 6 × 30 min sessions of electrodermal or placebo biofeedback given twice a week over 3 weeks. Perceived pain was evaluated using the Numeric Rating Scale (NRS) for pain, while systemic inflammation was examined with measurements of morning circulating C-reactive protein (CRP) concentrations.

RESULTS: Perceived pain in the treatment group was significantly lessened in the NRS scale (p < 005), while circulating CRP concentrations were also decreased (p < 0.05). Parallel placebo studies showed no changes in perceived pain or morning serum CRP concentrations.

DISCUSSION: Use of the electrodermal biofeedback RegMatEx device was associated with reduced pain perception and decreased chronic systemic inflammation, with stability over time. This did not occur in the placebo-treated group. The symptomatology of the treated patients significantly improved in terms of pain relief as shown on the NRS scale, and this was accompanied by reported improvements in mobility, mood, and quality of life.

CONCLUSIONS: The RegMatEx electrodermal biofeedback procedure is a non-invasive and easy to use therapeutic method, free of side effects, with high patient acceptability, excellent efficacy, and duration of effect, and, hence, a valuable tool in the treatment of chronic pain and inflammation.

Use of transcutaneous electrical stimulation and biofeedback for the treatment of vulvodynia (vulvar vestibular syndrome): result of 3 years of experience]. Dionisi B1, Anglana F, Inghirami P, Lippa P, Senatori R. Minerva Ginecol. 2008 Dec;60(6):485-91.

The safety, tolerability and efficacy of physical therapy with biofeedback and trans electrical nerve stimulation (TENS) with intravaginal probe for the treatment of vulvar pain and vulvar discomfort in women with vulvodynia, is evalued in the present study. Vulvodinia is a cronic syndrome of unexplained vulvar pain. Patients typically present with a history of intermittent or continuous, localized, vulvar pain, frequently accompanied by sexual dysfunction like entry dispareunia, burning and hiching localized to the vulvar vestibule.

METHODS: From January 2005 and June 2007, a total 145 women diagnosed with vulvodynia presented in the ambulatory for the Diagnosis and Treatment of Vulvar Pain and Pelvic Floor Dysfunction, Clinical ”Santa Famiglia”, Rome. Patients were treated with weekly biofeedback (BFB) and transcutaneous electroanalgesia (TENS), in association with functional electrical stimulation (FES) and home-therapy with stretching exercise of pelvic floor.

RESULTS: Hundred forty-five women completed both the biofeedback and trans electric nerve stimulation treatment for a total of 10 application, with a improvement of vulvar pain in 75.8% of cases.

CONCLUSION: The pelvic floor relaxation with biofeedback and ellectroanalgesia is safe and effective in improvement in vulvar pain and dyspareunia in women with vulvodynia.