Investigating the efficacy of transcranial direct current stimulation on chronic pain management in endometriosis patients: A randomized controlled trial protocol.

INTRODUCTION: Similar to chronic pain conditions, individuals with endometriosis can be affected by central sensitization syndrome (CSS), which is characterized by a loss of analgesia and central amplification of pain. Transcranial direct current stimulation (tDCS) has shown potential as an effective intervention to improve pain generated by other chronic pain conditions impacted by CSS, such as fibromyalgia and chronic pelvic issues. This study aims to evaluate the effectiveness of tDCS on pain, fatigue, and quality of life among patients affected by endometriosis. METHODS: This is a single-center, parallel, double-blinded, randomized, controlled clinical trial protocol study. We aim to recruit 40 participants affected by endometriosis (active group, n = 20; sham group, n = 20). Anodal tDCS will be delivered at an intensity of 2mA, applied over the primary motor cortex for 20 minutes per day for 10 consecutive days. There will be four assessment times: 1 week before beginning the intervention; on the 10th day following the last tDCS session; and 1 and 2 months after the last tDCS session. Pain evaluated by the algometry will be the primary outcome. Pain intensity, quality of life, fatigue, and global perception of change will be the secondary outcomes. We will calculate the effects of the active versus sham stimulation on primary and secondary outcomes by using generalized estimated equations or mixed model analysis. The effect size calculation will represent the effect measure. We expect that only the active group show reductions in pain, fatigue, and quality of life. The results of this trial will produce an important first step in providing evidence on the effectiveness of neuromodulation for the management of pain and will provide data to support new studies on tDCS. REGISTRATION: Brazilian Clinical Trials Registry (RBR-4q69573).

Pelvic Floor Muscle Training With and Without Electrical Stimulation in the Treatment of Lower Urinary Tract Symptoms in Women With Multiple Sclerosis.

PURPOSE: The aim of this study was to evaluate the effect of intravaginal neuromuscular electrical stimulation (NMES) and transcutaneous tibial nerve stimulation (TTNS) on lower urinary tract symptoms (LUTS) and health-related quality of life in women undergoing pelvic floor muscle (PFM) training (PFMT) with multiple sclerosis (MS) and to compare the efficacy of these 2 approaches. DESIGN: Randomized controlled trial. METHODS: Thirty women with MS and LUTS were randomly allocated to 1 of 3 groups and received treatment for 12 weeks. Ten women in group 1 received PFMT with electromyographic (EMG) biofeedback and sham NMES. Ten women in group 2 underwent PFMT with EMG biofeedback and intravaginal NMES, and 10 subjects in group 3 received PFMT with EMG biofeedback and TTNS. Multiple assessments, performed before and after treatment, included a 24-hour pad test, 3-day bladder diary, assessment of PFM function (strength and muscle tone), urodynamic studies, and validated questionnaires including Overactive Bladder Questionnaire (OAB-V8), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and Qualiveen instrument. RESULTS: All groups showed reductions in pad weight, frequency of urgency and urge urinary incontinence episodes, improvement in all domains of the PFM assessment, and lower scores on the OAB-V8 and ICIQ-SF questionnaires following treatment. Subjects in group 2 achieved significantly greater improvement in PFM tone, flexibility, ability to relax PFMs, and OAB-V8 scores when compared to subjects in groups 1 and 3. CONCLUSION: Results suggest that PFMT alone or in combination with intravaginal NMES or TTNS is effective in the treatment of LUTS in patients with MS. The combination of PFMT and NMES offers some advantage in the reduction of PFM tone and symptoms of overactive bladder.