Transcranial Direct Stimulation in Chronic Pelvic Pain

Spaulding Rehabilitation Hospital35 enrolled

Overview

The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is that tDCS will decrease pain significantly when compared to sham stimulation.

The study encompasses two experiments: The first one involves patients with chronic pain, receiving 10 sessions of stimulation, active or sham (parallel design). The second experiment involves involves healthy subjects, receiving active or sham tDCS over the primary motor cortex (crossover design).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pelvic Pain Healthy

Interventions

Transcranial Direct Current StimulationDEVICE

Chronic pain subjects will be randomized to receive either active or sham stimulation for the duration of the trial. The subject will receive 10 consecutive sessions at an intensity of 2mA with each session lasting 20 minutes. If the subject receives active stimulation the current will be applied for the full 20 minutes, while in the sham group current will only be applied for 30 seconds. In the healthy cohort, subjects will receive one session of active stimulation and one session of sham stimulation. The parameters will be the same as the pain subjects, at an intensity of 2mA for 20 minutes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Providing informed consent to participate in the study 2. 18 to 64 years old 3. Having symptoms of pelvic pain for more than 6 months with an average of 3 on a 0-10 VAS scale (for pelvic pain subjects only) 4. No history of or current genitourinary tuberculosis as self reported 5. No history of urethral cancer as self reported 6. No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported 7. No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported 8. No current vaginal infection as self reported 9. No active herpes in previous 3 months as self reported 10. No antimicrobials for urinary tract infections in previous 3 months as self reported 11. Never treated with cyclophosphamide as self reported 12. No radiation cystitis as self reported 13. No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported 14. Absence of bladder, ureteral or urethral calculi for previous 3 months as self reported 15. No urethritis for previous 3 months as self reported 16. No urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or bladder biopsy in previous 3 months as self reported 17. Must not be pregnant 18. Eligible to MRI according to MRI screening checklist 19. No contraindications to tDCS: 20. No history of alcohol or drug abuse within the past 6 months as self reported 21. No use of carbamazepine as self reported 22. Does not have severe depression (with a score of \>30 in the Beck Depression Inventory) 23. No history of neurological disorders as self reported 24. No history of unexplained fainting spells as self reported, 25. No history of head injury resulting in more than a momentary loss of consciousness as self reported 26. Have had no neurosurgery as self reported 27. No history of psychological disorders as self reported 28. Must have the ability to feel pain as self reported

Locations (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Pain Assessment

We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS).

Time frame: baseline and at 2 weeks

Pressure Pain Threshold

Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. The change in pressure pain threshold (post minus pre intervention) is use for the analysis.

Time frame: baseline and at 2 weeks

Secondary Outcomes

Quality of Life Scale (QOLS)

The questionnaire on quality of life was performed at the end of the treatment session and compared between the two groups (active and sham) in patients with pelvic pain (Exp. 1). The QOLS has 16 items (total scores ranging from 16 to 112) the highest scores corresponding the best QOL.

Time frame: 2 weeks

Clinical Global Impression - CGI

This scale measures illness severity and was performed on patients with pelvic pain (Exp. 1). The scale was performed at end of the treatment and compared between the two groups (real and sham). The scale is divided in 3 sub-scales: Severity of illness (0-7), global improvement (0-7) and efficacy index (0-16), total scores ranging from 0 to 30. The highest scores corresponding to lowest clinical improvement.

Time frame: 2 weeks

Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain

The scale was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).

Data from ClinicalTrials.gov

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