Phase 2 N=26 Randomized Double-blind Treatment

Transcranial Direct Stimulation in Chronic Pelvic Pain

Pelvic Pain · Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01143636 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Pain Assessment — -2.375; -1.625 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Transcranial Direct Current Stimulation (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Spaulding Rehabilitation Hospital
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain Assessment	-2.375; -1.625	—
PRIMARY Pressure Pain Threshold	1.25; -1	—
SECONDARY Quality of Life Scale (QOLS)	81.2; 78	—
SECONDARY Clinical Global Impression - CGI	2.8; 3.3	—
SECONDARY 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	0.8; 2.5	—
SECONDARY Mini Mental Scale - MMS	29.4; 28.75	—
SECONDARY Beck Depression Inventory - BDI.	10; 6.75	—
SECONDARY Patient Global Assessment - PGA	2.8; 2.75	—
SECONDARY Von Frey	0.7; -0.29	—
SECONDARY Pain Pressure Threshold Test - PPT	2.21; 1.41	—
SECONDARY Diffuse Noxious Inhibitory Controls - DNIC.	2.46; 0.66	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Providing informed consent to participate in the study
18 to 64 years old
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)
No history of or current genitourinary tuberculosis as self reported
No history of urethral cancer as self reported
No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported
No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported
No current vaginal infection as self reported
No active herpes in previous 3 months as self reported
No antimicrobials for urinary tract infections in previous 3 months as self reported
Never treated with cyclophosphamide as self reported
No radiation cystitis as self reported
No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported
Absence of bladder, ureteral or urethral calculi for previous 3 months as self reported
No urethritis for previous 3 months as self reported
No urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or bladder biopsy in previous 3 months as self reported
Must not be pregnant
Eligible to MRI according to MRI screening checklist
No contraindications to tDCS:
No history of alcohol or drug abuse within the past 6 months as self reported
No use of carbamazepine as self reported
Does not have severe depression (with a score of >30 in the Beck Depression Inventory)
No history of neurological disorders as self reported
No history of unexplained fainting spells as self reported,
No history of head injury resulting in more than a momentary loss of consciousness as self reported
Have had no neurosurgery as self reported
No history of psychological disorders as self reported
Must have the ability to feel pain as self reported

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01143636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.