Transcranial Direct Stimulation in Chronic Pelvic Pain

• Sponsor: Spaulding Rehabilitation Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01143636
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arms: 4
• Duration (Months): 37
• Patients Per Site Per Month: 0.9

Study Details

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.

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 Design

• Study Type: Interventional
• 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.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: Apr 1, 2010
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

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 Names: 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 Names: 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 Names: 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 Names: tDCS, electrical stimulation

Outcome Measures

Primary Outcome Measures

1. Pain Assessment [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 [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) [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 [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 [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 [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. [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 [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 [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 [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. [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spaulding Rehabilitation Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Spaulding Rehabilitation Hospital

Investigators

• Principal Investigator: Felipe Fregni, MD, PhD, Spaulding Rehabilitation Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT01143636
• Other Study ID Numbers: 2009-P-002048
• First Posted: Jun 14, 2010
• Last Update Posted: Apr 24, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital: Transcranial direct current stimulation; Chronic Pelvic Pain
• Additional relevant MeSH terms: Pelvic Pain

Study Results

Participant Flow

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS	Healthy Controls: Active tDCS/Sham tDCS	Healthy Subjects: Sham tDCS/Active tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.	Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.	Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
Period Title: Overall Study
STARTED	6	5	8	7
COMPLETED	5	4	8	7
NOT COMPLETED	1	1	0	0

Baseline Characteristics

Arm/Group Title	Active tDCS - Pelvic Pain	Sham tDCS - Pelvic Pain	Active tDCS&Sham tDCS - Healthy Controls	Total
Arm/Group Description	Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.	Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.	Total of all reporting groups
Overall Participants	6	5	15	26
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	6 100%	5 100%	15 100%	26 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex/Gender, Customized (participants) [Number]
Female	5 83.3%	4 80%	9 60%	18 69.2%
Male	1 16.7%	1 20%	6 40%	8 30.8%
Region of Enrollment (participants) [Number]
United States	6 100%	5 100%	15 100%	26 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The VAS is performed in patients with pelvic pain (Experiment 1).

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Measure Participants	5	4
Mean (Standard Deviation) [units on a scale]	-2.375 (1.79)	-1.625 (2.46)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The pain pressure test is performed in healthy participants (exp 2).

Arm/Group Title	Healthy Controls: Active tDCS	Healthy Subjects: Sham tDCS
Arm/Group Description	Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.	Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
Measure Participants	15	15
Mean (Standard Deviation) [lb]	1.25 (0.75)	-1 (0.5)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

We compared active and sham groups (Exp. 1)

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Measure Participants	5	4
Mean (Standard Deviation) [units on a scale]	81.2 (15.4)	78 (11.43)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with pelvic pain (Exp 1)

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Measure Participants	5	4
Mean (Standard Deviation) [units on a scale]	2.8 (0.4)	3.3 (1.2)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This outcome measure was performed in patients with pelvic pain (Exp 1).

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Measure Participants	5	4
Mean (Standard Deviation) [units on a scale]	0.8 (0.9)	2.5 (2.1)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with pelvic pain (Exp. 1).

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Measure Participants	5	4
Mean (Standard Deviation) [units on a scale]	29.4 (0.8)	28.75 (1.1)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with pelvic pain (Exp. 1).

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Measure Participants	5	4
Mean (Standard Deviation) [units on a scale]	10 (9.7)	6.75 (6.8)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with pelvic pain (Exp. 1).

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Measure Participants	5	4
Mean (Standard Deviation) [units on a scale]	2.8 (0.9)	2.75 (1.3)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with pelvic pain (Exp. 1).

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Measure Participants	5	4
Mean (Standard Deviation) [grams]	0.7 (0.76)	-0.29 (0.48)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Patients with pelvic pain (Exp. 1).

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Measure Participants	5	4
Mean (Standard Deviation) [lb]	2.21 (3.93)	1.41 (2.31)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

patients with pelvic pain (Exp. 1).

Arm/Group Title	Pelvic Pain, Active tDCS	Pelvic Pain, Sham tDCS
Arm/Group Description	Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.	Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
Measure Participants	5	4
Mean (Standard Deviation) [lb]	2.46 (4.84)	0.66 (2.39)

Adverse Events

Arm/Group Title	SHAM tDCS - Pelvic Pain Patients		ACTIVE tDCS - Pelvic Pain Patients		SHAM tDCS - Healthy		ACTIVE tDCS - Sham
Arm/Group Description	SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side. For sham-controlled tDCS subjects, the current will be applied only for 30 seconds. Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes.		ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side. Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes.		SHAM tDCS: Subjects will receive a single session of sham tDCS. The anode electrode will be placed on the primary motor cortex. For sham-controlled tDCS subjects, the current will be applied only for 30 seconds. Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes.		ACTIVE tDCS: Subjects will receive a single session of active tDCS. The anode electrode will be placed on the primary motor cortex. Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes.
All Cause Mortality
	SHAM tDCS - Pelvic Pain Patients		ACTIVE tDCS - Pelvic Pain Patients		SHAM tDCS - Healthy		ACTIVE tDCS - Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	SHAM tDCS - Pelvic Pain Patients		ACTIVE tDCS - Pelvic Pain Patients		SHAM tDCS - Healthy		ACTIVE tDCS - Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/5 (0%)		0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	SHAM tDCS - Pelvic Pain Patients		ACTIVE tDCS - Pelvic Pain Patients		SHAM tDCS - Healthy		ACTIVE tDCS - Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/4 (75%)		5/5 (100%)		11/15 (73.3%)		15/15 (100%)
General disorders
Nausea	0/4 (0%)		1/5 (20%)		0/15 (0%)		0/15 (0%)
Nervous system disorders
Headache	1/4 (25%)		1/5 (20%)		1/15 (6.7%)		1/15 (6.7%)
Neck pain	1/4 (25%)		1/5 (20%)		0/15 (0%)		0/15 (0%)
Sleepiness	1/4 (25%)		3/5 (60%)		6/15 (40%)		5/15 (33.3%)
Diziness	2/4 (50%)		0/5 (0%)		0/15 (0%)		0/15 (0%)
Trouble concentrating	0/4 (0%)		1/5 (20%)		0/15 (0%)		0/15 (0%)
Acute mood change	0/4 (0%)		1/5 (20%)		0/15 (0%)		0/15 (0%)
Skin and subcutaneous tissue disorders
Tingling	3/4 (75%)		5/5 (100%)		10/15 (66.7%)		11/15 (73.3%)
Skin redness	2/4 (50%)		4/5 (80%)		8/15 (53.3%)		7/15 (46.7%)
Scalp burning sensation	0/4 (0%)		1/5 (20%)		0/15 (0%)		1/15 (6.7%)
Itching	0/4 (0%)		1/5 (20%)		1/15 (6.7%)		2/15 (13.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.