- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02704611
Direct Current Stimulation for Treatment of Fibromyalgia
Direct Current Stimulation Versus Sham for Treatment of Fibromyalgia: a Double Blinded Randomized Controlled Trial
The aim of this study is to assess the effectiveness of transcranial direct current stimulation (tDCS) in treating fibromyalgia.
Participants will be randomly assigned to one of the two groups: Group I (Intervention group) tDCS (2mA for 25 minutes on 5 consecutive days/week for 2 weeks with the anode centered over M1 bilaterally Anodal tDCS for 20 minutes at 1.5 mA (15 s ramp in and 15 s ramp out) will be applied daily for 10 consecutive days (5 sessions/week) . The anodal electrode (24 cm² with current density of 0.08 mA (2mA/24 cm²) will be placed over the left primary motor area in group I, and the reference electrode (24 cm² will be fixed over the contralateral arm (extracephalic).
Daily tDCS was given to prolong and stabilize these long-lasting after-effects. Group II will receive sham tDCS will be applied using the above described parameters in group I. For sham tDCS, the placement of the electrodes, current intensity, and ramp time was identical to real tDCS stimulation group; however, the stimulation lasted only for 30 Sec. However, since none of the patients have been experienced tDCS previously, they were unaware of which stimulation is real and which sham is. The investigator responsible for delivering tDCS had no contact with the patients. All study participants will be followed up by the same evaluation sheet and by an evaluator who are blinded to the type of intervention she /he has received.Evaluation will be done pre assessment, post 5 sessions, post 10 sessions, post one month and post 2 months by using wide spread pain index (WPI) & symptoms severity of fibromyalgia, measuring visual analogue scale (VAS), Depression and anxiety will be assessed using Hamilton Depression Scale (HDS) and anxiety scale, pain sensitivity threshold by using Electronic Von Frey unit EVF4 . Determination of human beta-endorphin level before start sessions and after end 10 sessions.
Study Overview
Detailed Description
The purpose of this study is to assess the effectiveness of transcranial direct current stimulation (tDCS) in relieving pain of patients with fibromyalgia. Eligible participants will be randomly assigned to one of the two groups: Group I (Intervention group) tDCS (2mA for 25 minutes on 5 consecutive days/week for 2 weeks with the anode centered over M1 bilaterally Anodal tDCS for 20 minutes at 1.5 mA (15 s ramp in and 15 s ramp out) will be applied daily for 10 consecutive days (5 sessions/week) . The anodal electrode (24 cm² with current density of 0.08 mA (2mA/24 cm²) will be placed over the left primary motor area in group I, and the reference electrode (24 cm² will be fixed over the contralateral arm (extracephalic).
Because brief exposure to tDCS has no after-effects whereas researchers used 20min duration in order to produce robust after-effects. Daily tDCS was given to prolong and stabilize these long-lasting after-effects. Group II will receive sham tDCS will be applied using the above described parameters in group I. For sham tDCS, the placement of the electrodes, current intensity, and ramp time was identical to real tDCS stimulation group; however, the stimulation lasted only for 30 Sec. However, since none of the patients have been experienced tDCS previously, they were unaware of which stimulation is real and which sham is. The investigator responsible for delivering tDCS had no contact with the patients. All study participants will be followed up by the same evaluation sheet and by an evaluator who are blinded to the type of intervention she /he has received.Evaluation will be done pre assessment, post 5 sessions, post 10 sessions, post one month and post 2 months by using wide spread pain index (WPI) & symptoms severity of fibromyalgia, measuring visual analogue scale (VAS), Depression and anxiety will be assessed using Hamilton Depression Scale (HDS) and anxiety scale, pain sensitivity threshold by using Electronic Von Frey unit EVF4 . Determination of human beta-endorphin level before start sessions and after end 10 sessions.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dina H. El-Hammady, MD
- Phone Number: 00201223971467
- Email: dinael_hammady73@yahoo.com
Study Contact Backup
- Name: Eman Khedr, MD
- Phone Number: 00201223971457
- Email: emankhedr99@yahoo.com
Study Locations
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-
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Assiut, Egypt, 71111
- Recruiting
- Assiut University Hospital
-
Contact:
- Dina Elhammady, MD
- Phone Number: 1223971467
-
Contact:
- Eman khedr, MD
- Phone Number: 1223971457
- Email: emankhedr99@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients diagnosed as fibromyalgia according to the American college of rheumatology classification, (ACR) 2010 and referred to any of the above clinics for treatment.
- Patients must have a mean pain score ≥ 4 on a 10-point visual analog scale (VAS) during the 2 weeks preceding the clinical trial.
- Patients from nearby districts to ensure good availability for follow-up.
Exclusion Criteria:
- Patients refused to participate in the trial.
- Patients with any uncontrolled clinical disease (as evaluated by each patient's clinician), such as any associated rheumatologic, thyroid, cardiovascular, pulmonary, hematologic, or renal diseases, pregnancy, lactation, and neuropsychiatric disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group I
Real tDCS (2mA for 25 minutes on 5 consecutive days/week for 2 weeks with the anode centered over M1 bilaterally.
Anodal tDCS for 20 minutes at 1.5mA (15 s ramp in and 15 s ramp out) will be applied daily for 10 consecutive days (5 sessions/week).
|
Real tDCS (2mA for 25 minutes on 5 consecutive days/week for 2 weeks with the anode centered over M1 bilaterally.
Anodal tDCS for 20 minutes at 1.5mA (15 s ramp in and 15 s ramp out) will be applied daily for 10 consecutive days (5 sessions/week).
The anodal electrode 24 cm² with current density of 0.08 mA (2mA/24 cm²) will be placed over the left primary motor area in group I, and the reference electrode (24 cm² will be fixed over the contralateral arm (extracephalic).
Other Names:
|
Sham Comparator: Group II
Sham tDCS will be applied using the above described parameters in group.
For sham tDCS, the placement of the electrodes, current intensity, and ramp time was identical to real tDCS stimulation group; however, the stimulation lasted only for 30 Sec.
|
Sham tDCS will be applied using the above described parameters in group.
For sham tDCS, the placement of the electrodes, current intensity, and ramp time was identical to real tDCS stimulation group; however, the stimulation lasted only for 30 Sec.
However, since none of the patients have been experienced tDCS previously, they were unaware of which stimulation is real and which sham is.
The investigator responsible for delivering tDCS had no contact with the patients.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in pain Scores as measured by the Visual Analog Scale
Time Frame: 2 months
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eman Khedr, MD, Professor of Neurology, Faculty of Medicine, Assiut University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DCS in fibromyalgia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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