Overview

This trial has been completed.

Conditions pelvic pain, healthy
Treatment transcranial direct current stimulation
Phase phase 2
Sponsor Spaulding Rehabilitation Hospital
Start date April 2010
End date December 2012
Trial size 35 participants
Trial identifier NCT01143636, 2009-P-002048

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Intervention model description for the experiment in patients with pelvic pain, the design is parallel. for the experiment in healthy subjects, the design is crossover.
Primary purpose treatment
Masking investigator, outcomes assessor
Arm
(Sham Comparator)
ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode will be placed over the primary motor cortex of the predominantly painful side.
transcranial direct current stimulation tDCS, electrical stimulation
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.
(Experimental)
SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode will be placed over the primary motor cortex of the predominantly painful side.
transcranial direct current stimulation tDCS, electrical stimulation
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.
(Experimental)
The healthy controls will undergo one day of treatment with active tDCS. All participants will receive both active and sham stimulation in a randomized order.
transcranial direct current stimulation tDCS, electrical stimulation
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.
(Experimental)
The healthy controls will undergo one day of treatment with sham tDCS. All participants will receive both active and sham stimulation in a randomized order.
transcranial direct current stimulation tDCS, electrical stimulation
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.

Primary Outcomes

Measure
Pain Assessment
time frame: baseline and at 2 weeks
Pressure Pain Threshold
time frame: baseline and at 2 weeks

Secondary Outcomes

Measure
Quality of Life Scale (QOLS)
time frame: 2 weeks
Clinical Global Impression - CGI
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
time frame: 2 weeks
Mini Mental Scale - MMS
time frame: 2 weeks
Beck Depression Inventory - BDI.
time frame: 2 weeks
Patient Global Assessment - PGA
time frame: 2 weeks
Von Frey
time frame: baseline and at 2 weeks
Pain Pressure Threshold Test - PPT
time frame: baseline and at 2 weeks
Diffuse Noxious Inhibitory Controls - DNIC.
time frame: baseline and at 2 weeks

Eligibility Criteria

All participants from 18 years up to 64 years old.

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

Additional Information

Official title Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.
Principal investigator Felipe Fregni, MD, PhD
Description 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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.