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Direct Current Stimulation for Treatment of Fibromyalgia

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ClinicalTrials.gov Identifier: NCT02704611
Recruitment Status : Unknown
Verified October 2015 by Dina Hatem Elhammady, Assiut University.
Recruitment status was:  Recruiting
First Posted : March 10, 2016
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
Dina Hatem Elhammady, Assiut University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Device: Real tDCS Device: Sham tDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Direct Current Stimulation Versus Sham for Treatment of Fibromyalgia: a Double Blinded Randomized Controlled Trial
Study Start Date : October 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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).
Device: Real tDCS
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 Name: Real trans-cranial direct current stimulation

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.
Device: Sham tDCS
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 Name: Sham trans-cranial direct current stimulation




Primary Outcome Measures :
  1. Change in pain Scores as measured by the Visual Analog Scale [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704611


Contacts
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Contact: Dina H. El-Hammady, MD 00201223971467 dinael_hammady73@yahoo.com
Contact: Eman Khedr, MD 00201223971457 emankhedr99@yahoo.com

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt, 71111
Contact: Dina Elhammady, MD    1223971467      
Contact: Eman khedr, MD    1223971457    emankhedr99@yahoo.com   
Sponsors and Collaborators
Dina Hatem Elhammady
Investigators
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Principal Investigator: Eman Khedr, MD Professor of Neurology, Faculty of Medicine, Assiut University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dina Hatem Elhammady, Clinical Professor, Assiut University
ClinicalTrials.gov Identifier: NCT02704611    
Other Study ID Numbers: DCS in fibromyalgia
First Posted: March 10, 2016    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: October 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases