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Transcranial Direct Stimulation in Chronic Pelvic Pain

Primary Purpose

Pelvic Pain, Healthy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
Spaulding Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring Transcranial direct current stimulation, Chronic Pelvic Pain

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Spaulding Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Arm Label

Active tDCS - pelvic pain patients

Sham tDCS - pelvic pain patients

Active tDCS - healthy

Sham tDCS - healthy

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.
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).
Mini Mental Scale - MMS
This scale measures patients cognitive impairment. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 30 points scale (total scores ranging from 0 to 30), the highest score corresponds to the highest cognitive status.
Beck Depression Inventory - BDI.
BDI is a questionnaire used for detecting depression. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 21-question multiple-choice self-report inventory (scores ranging from 0 to 63 - 0 corresponds to no symptom of depression).
Patient Global Assessment - PGA
This scale measures patient's assessment of general health. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). The patient has to answer the question "how is your health overall" on a scale going from 0 to 10 (0 being the worst, 10 being the best).
Von Frey
This test is used to test subjects' sensitivity to a mechanical stimulus. It was performed before and and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). A set of filaments, typically from 0.008 grams force up to 300 grams force, is applied on the patients' skin. The mechanical threshold is defined as the moment when the patient detects the stimulus.
Pain Pressure Threshold Test - PPT
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.This test was applied before and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1).
Diffuse Noxious Inhibitory Controls - DNIC.
DNIC occurs when response from a painful stimulus (pain pressure threshold - PPT) is inhibited by another noxious stimulus (cold water). The difference between baseline and post treatment was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).

Full Information

First Posted
April 20, 2010
Last Updated
April 22, 2020
Sponsor
Spaulding Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01143636
Brief Title
Transcranial Direct Stimulation in Chronic Pelvic Pain
Official Title
Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Pain, Healthy
Keywords
Transcranial direct current stimulation, Chronic Pelvic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
For the experiment in patients with pelvic pain, the design is parallel. For the experiment in healthy subjects, the design is crossover.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS - pelvic pain patients
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Sham tDCS - pelvic pain patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Active tDCS - healthy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS - healthy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS, electrical stimulation
Intervention Description
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 Outcome Measure Information:
Title
Pain Assessment
Description
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
Title
Pressure Pain Threshold
Description
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 Outcome Measure Information:
Title
Quality of Life Scale (QOLS)
Description
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
Title
Clinical Global Impression - CGI
Description
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
Title
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
Description
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).
Time Frame
2 weeks
Title
Mini Mental Scale - MMS
Description
This scale measures patients cognitive impairment. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 30 points scale (total scores ranging from 0 to 30), the highest score corresponds to the highest cognitive status.
Time Frame
2 weeks
Title
Beck Depression Inventory - BDI.
Description
BDI is a questionnaire used for detecting depression. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 21-question multiple-choice self-report inventory (scores ranging from 0 to 63 - 0 corresponds to no symptom of depression).
Time Frame
2 weeks
Title
Patient Global Assessment - PGA
Description
This scale measures patient's assessment of general health. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). The patient has to answer the question "how is your health overall" on a scale going from 0 to 10 (0 being the worst, 10 being the best).
Time Frame
2 weeks
Title
Von Frey
Description
This test is used to test subjects' sensitivity to a mechanical stimulus. It was performed before and and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). A set of filaments, typically from 0.008 grams force up to 300 grams force, is applied on the patients' skin. The mechanical threshold is defined as the moment when the patient detects the stimulus.
Time Frame
baseline and at 2 weeks
Title
Pain Pressure Threshold Test - PPT
Description
Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.This test was applied before and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1).
Time Frame
baseline and at 2 weeks
Title
Diffuse Noxious Inhibitory Controls - DNIC.
Description
DNIC occurs when response from a painful stimulus (pain pressure threshold - PPT) is inhibited by another noxious stimulus (cold water). The difference between baseline and post treatment was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1).
Time Frame
baseline and at 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD, PhD
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Transcranial Direct Stimulation in Chronic Pelvic Pain

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