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Transcranial Direct Stimulation in Chronic Pelvic Pain

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ClinicalTrials.gov Identifier: NCT01143636
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

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.

Condition or disease Intervention/treatment Phase
Pelvic Pain Healthy Device: Transcranial Direct Current Stimulation Phase 2

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
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.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.
Study Start Date : April 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arm Intervention/treatment
Sham Comparator: Active tDCS - pelvic pain patients
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.
Device: Transcranial Direct Current 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.
Other Name: tDCS, electrical stimulation

Experimental: Sham tDCS - pelvic pain patients
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.
Device: Transcranial Direct Current 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.
Other Name: tDCS, electrical stimulation

Experimental: Active tDCS - healthy
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.
Device: Transcranial Direct Current 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.
Other Name: tDCS, electrical stimulation

Experimental: Sham tDCS - healthy
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.
Device: Transcranial Direct Current 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.
Other Name: tDCS, electrical stimulation




Primary Outcome Measures :
  1. Pain Assessment [ Time Frame: baseline and at 2 weeks ]
    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).

  2. Pressure Pain Threshold [ Time Frame: baseline and at 2 weeks ]

    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 :
  1. Quality of Life Scale (QOLS) [ Time Frame: 2 weeks ]
    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.

  2. Clinical Global Impression - CGI [ Time Frame: 2 weeks ]
    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.

  3. 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 ]
    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).

  4. Mini Mental Scale - MMS [ Time Frame: 2 weeks ]
    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.

  5. Beck Depression Inventory - BDI. [ Time Frame: 2 weeks ]
    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).

  6. Patient Global Assessment - PGA [ Time Frame: 2 weeks ]
    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).

  7. Von Frey [ Time Frame: baseline and at 2 weeks ]
    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.

  8. Pain Pressure Threshold Test - PPT [ Time Frame: baseline and at 2 weeks ]
    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).

  9. Diffuse Noxious Inhibitory Controls - DNIC. [ Time Frame: baseline and at 2 weeks ]
    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).



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143636


Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, MD, PhD Spaulding Rehabilitation Hospital

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01143636     History of Changes
Other Study ID Numbers: 2009-P-002048
First Posted: June 14, 2010    Key Record Dates
Results First Posted: March 15, 2017
Last Update Posted: March 15, 2017
Last Verified: March 2017

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
Transcranial direct current stimulation
Chronic Pelvic Pain

Additional relevant MeSH terms:
Pelvic Pain
Pain
Neurologic Manifestations
Signs and Symptoms