Skip to main content
OpenTrials
Completed

NCT Number: NCT01143636

Transcranial Direct Stimulation in Chronic Pelvic Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Pain Healthy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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 names: tDCS, electrical stimulation

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jun 14, 2010
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.