Clinical Trial: Transcranial Direct Stimulation in Chronic Pelvic Pain

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.

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 Summary:

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).

Sponsor: Spaulding Rehabilitation Hospital

Current Primary Outcome:

• 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).
• 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.

Original Primary Outcome: Sensory Test [ Time Frame: 2 months ]

Current Secondary Outcome:

• 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.
• 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.
• 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).
• 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.
• 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).
• 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).
• 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.
• 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).
• 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).

Original Secondary Outcome:

• Evidence of an increase in overall quality of life and mental health [ Time Frame: 2 months ]
  Measured by: 1) Analgesic use, 2) Quality of Life Scale (QOLS), 3) Subject Global Assessment (PGA), 4) Clinical Global Impression (CGI), 5) Beck Depression Inventory (BDI), 6) Visual Analog Scale (VAS) for anxiety, 7) tDCS Side Effects Questionnaire, 8) Mini-mental status exam
• Evidence of improvement in cognitive functioning [ Time Frame: 2 months ]
  Measured by: 1) Digit Span, 2) Trail making test - parts A and B, 3) Wisconsin Card Sorting Test (WCST), 4) Stroop task, 5) Simple reaction time, 6) Validation of Blinding, 7) Quantitative Sensory Assessment

Information By: Spaulding Rehabilitation Hospital

Dates:
Date Received: April 20, 2010
Date Started: April 2010
Date Completion:
Last Updated: March 14, 2017
Last Verified: March 2017