Healthy, Pelvic Pain
Conditions
Keywords
Transcranial direct current stimulation, 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 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).
Interventions
DEVICETranscranial 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.
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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). |
| 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. |
| 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. |
| 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). |
| 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). |
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS - Pelvic Pain 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. | 6 |
| Sham tDCS - Pelvic Pain 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. | 5 |
| Active tDCS&Sham tDCS - Healthy Controls 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. | 15 |
| Total | 26 |
Baseline characteristics
| Characteristic | Active tDCS - Pelvic Pain | Sham tDCS - Pelvic Pain | Active tDCS&Sham tDCS - Healthy Controls | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 15 Participants | 26 Participants |
| Region of Enrollment United States | 6 participants | 5 participants | 15 participants | 26 participants |
| Sex/Gender, Customized Female | 5 participants | 4 participants | 9 participants | 18 participants |
| Sex/Gender, Customized Male | 1 participants | 1 participants | 6 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 4 | 5 / 5 | 11 / 15 | 15 / 15 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 | 0 / 15 | 0 / 15 |
Outcome results
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).
Time frame: baseline and at 2 weeks
Population: The VAS is performed in patients with pelvic pain (Experiment 1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | Pain Assessment | -2.375 units on a scale | Standard Deviation 1.79 |
| Pelvic Pain, Sham tDCS | Pain Assessment | -1.625 units on a scale | Standard Deviation 2.46 |
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.
Time frame: baseline and at 2 weeks
Population: The pain pressure test is performed in healthy participants (exp 2).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | Pressure Pain Threshold | 1.25 lb | Standard Deviation 0.75 |
| Pelvic Pain, Sham tDCS | Pressure Pain Threshold | -1 lb | Standard Deviation 0.5 |
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).
Time frame: 2 weeks
Population: Patients with pelvic pain (Exp. 1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | Beck Depression Inventory - BDI. | 10 units on a scale | Standard Deviation 9.7 |
| Pelvic Pain, Sham tDCS | Beck Depression Inventory - BDI. | 6.75 units on a scale | Standard Deviation 6.8 |
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.
Time frame: 2 weeks
Population: Patients with pelvic pain (Exp 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | Clinical Global Impression - CGI | 2.8 units on a scale | Standard Deviation 0.4 |
| Pelvic Pain, Sham tDCS | Clinical Global Impression - CGI | 3.3 units on a scale | Standard Deviation 1.2 |
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).
Time frame: baseline and at 2 weeks
Population: patients with pelvic pain (Exp. 1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | Diffuse Noxious Inhibitory Controls - DNIC. | 2.46 lb | Standard Deviation 4.84 |
| Pelvic Pain, Sham tDCS | Diffuse Noxious Inhibitory Controls - DNIC. | 0.66 lb | Standard Deviation 2.39 |
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.
Time frame: 2 weeks
Population: Patients with pelvic pain (Exp. 1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | Mini Mental Scale - MMS | 29.4 units on a scale | Standard Deviation 0.8 |
| Pelvic Pain, Sham tDCS | Mini Mental Scale - MMS | 28.75 units on a scale | Standard Deviation 1.1 |
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).
Time frame: baseline and at 2 weeks
Population: Patients with pelvic pain (Exp. 1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | Pain Pressure Threshold Test - PPT | 2.21 lb | Standard Deviation 3.93 |
| Pelvic Pain, Sham tDCS | Pain Pressure Threshold Test - PPT | 1.41 lb | Standard Deviation 2.31 |
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).
Time frame: 2 weeks
Population: Patients with pelvic pain (Exp. 1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | Patient Global Assessment - PGA | 2.8 units on a scale | Standard Deviation 0.9 |
| Pelvic Pain, Sham tDCS | Patient Global Assessment - PGA | 2.75 units on a scale | Standard Deviation 1.3 |
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.
Time frame: 2 weeks
Population: We compared active and sham groups (Exp. 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | Quality of Life Scale (QOLS) | 81.2 units on a scale | Standard Deviation 15.4 |
| Pelvic Pain, Sham tDCS | Quality of Life Scale (QOLS) | 78 units on a scale | Standard Deviation 11.43 |
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).
Time frame: 2 weeks
Population: This outcome measure was performed in patients with pelvic pain (Exp 1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | 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 | 0.8 units on a scale | Standard Deviation 0.9 |
| Pelvic Pain, Sham tDCS | 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 | 2.5 units on a scale | Standard Deviation 2.1 |
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.
Time frame: baseline and at 2 weeks
Population: Patients with pelvic pain (Exp. 1).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Pain, Active tDCS | Von Frey | 0.7 grams | Standard Deviation 0.76 |
| Pelvic Pain, Sham tDCS | Von Frey | -0.29 grams | Standard Deviation 0.48 |