Transcranial Direct Stimulation in Chronic Pelvic Pain
22 aprile 2020 aggiornato da: Felipe Fregni, Spaulding Rehabilitation Hospital
Investigation and Treatment of Central Nervous System Dysfunction 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Interventistico
Iscrizione (Effettivo)
35
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Spaulding Rehabilitation Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 64 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore fittizio: 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.
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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.
Altri nomi:
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Sperimentale: 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.
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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.
Altri nomi:
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Sperimentale: 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.
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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.
Altri nomi:
|
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Sperimentale: 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.
|
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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain Assessment
Lasso di tempo: baseline and at 2 weeks
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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).
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baseline and at 2 weeks
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Pressure Pain Threshold
Lasso di tempo: baseline and at 2 weeks
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Quality of Life Scale (QOLS)
Lasso di tempo: 2 weeks
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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.
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2 weeks
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Clinical Global Impression - CGI
Lasso di tempo: 2 weeks
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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.
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2 weeks
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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
Lasso di tempo: 2 weeks
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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).
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2 weeks
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Mini Mental Scale - MMS
Lasso di tempo: 2 weeks
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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.
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2 weeks
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Beck Depression Inventory - BDI.
Lasso di tempo: 2 weeks
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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).
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2 weeks
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Patient Global Assessment - PGA
Lasso di tempo: 2 weeks
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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).
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2 weeks
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Von Frey
Lasso di tempo: baseline and at 2 weeks
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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.
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baseline and at 2 weeks
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Pain Pressure Threshold Test - PPT
Lasso di tempo: baseline and at 2 weeks
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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).
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baseline and at 2 weeks
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Diffuse Noxious Inhibitory Controls - DNIC.
Lasso di tempo: baseline and at 2 weeks
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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).
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baseline and at 2 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 aprile 2010
Completamento primario (Effettivo)
1 dicembre 2012
Completamento dello studio (Effettivo)
1 maggio 2013
Date di iscrizione allo studio
Primo inviato
20 aprile 2010
Primo inviato che soddisfa i criteri di controllo qualità
11 giugno 2010
Primo Inserito (Stima)
14 giugno 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
24 aprile 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 aprile 2020
Ultimo verificato
1 aprile 2020
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2009-P-002048
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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