Transcranial Direct Stimulation in Chronic Pelvic Pain

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01143636
• Other study ID #: 2009-P-002048
• Status: Completed
• Phase: Phase 2
• Start date: April 2010
• Est. completion date: May 2013

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Pelvic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline and at 2 weeks
Primary	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.	baseline and at 2 weeks
Secondary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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).	2 weeks
Secondary	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.	2 weeks
Secondary	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).	2 weeks
Secondary	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).	2 weeks
Secondary	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.	baseline and at 2 weeks
Secondary	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).	baseline and at 2 weeks
Secondary	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).	baseline and at 2 weeks