FibromyalgiaNCT02704611
Direct Current Stimulation for Treatment of Fibromyalgia
A study testing Real tDCS in people with Fibromyalgia, run by Dina Hatem Elhammady at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Real tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, Asyut Governorate, 71111
Dina Elhammady, MD, 1223971467
Eman khedr, MD, 1223971457, emankhedr99@yahoo.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Fibromyalgia
- Being tested
- Real tDCS, Sham tDCS
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real tDCSDevice
Also called Real trans-cranial direct current stimulation
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).
Sham tDCSDevice
Also called Sham trans-cranial direct current stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | 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). Receives: Device: Real tDCS |
| Group II | Sham comparator | 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. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain Scores as measured by the Visual Analog Scale
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dina Hatem Elhammady
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dina Hatem Elhammady, Assiut University
- Investigators
- Eman Khedr, MD, Principal investigator, Professor of Neurology, Faculty of Medicine, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704611
- Sponsor's protocol ID
- DCS in fibromyalgia
- Status last verified
- Oct 2015
- First submitted
- 4 Mar 2016
- Last updated
- 10 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Khedr EM, Omran EAH, Ismail NM, El-Hammady DH, Goma SH, Kotb H, Galal H, Osman AM, Farghaly HSM, Karim AA, Ahmed GA. Effects of transcranial direct current stimulation on pain, mood and serum endorphin level in the treatment of fibromyalgia: A double blinded, randomized clinical trial. Brain Stimul. 2017 Sep-Oct;10(5):893-901. doi: 10.1016/j.brs.2017.06.006. Epub 2017 Jun 23.
PubMed 28684258
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Current Stimulation Versus Sham for Treatment of Fibromyalgia: a Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02704611
- Acronym / sponsor ID
- DCS in fibromyalgia
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Dina Hatem ElhammadyUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 10 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Device: Real tDCSReal 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). |
| Group II | Sham comparator | Device: Sham tDCSSham 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients diagnosed as fibromyalgia according to the American college of rheumatology classification, (ACR) 2010 and referred to any of the above clinics for treatment.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real tDCSAlso: Real trans-cranial direct current stimulationReal 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). | Device | Group I |
| Sham tDCSAlso: Sham trans-cranial direct current stimulationSham 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. | Device | Group II |
Primary outcome
Change in pain Scores as measured by the Visual Analog Scale
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
- Derived from this study: PubMed 28684258Khedr EM, Omran EAH, Ismail NM, El-Hammady DH, Goma SH, Kotb H, Galal H, Osman AM, Farghaly HSM, Karim AA, Ahmed GA. Effects of transcranial direct current stimulation on pain, mood and serum endorphin level in the treatment of fibromyalgia: A double blinded, randomized clinical trial. Brain Stimul. 2017 Sep-Oct;10(5):893-901. doi: 10.1016/j.brs.2017.06.006. Epub 2017 Jun 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman Khedr, MD principal investigator
Professor of Neurology, Faculty of Medicine, Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real tDCS in people with Fibromyalgia, run by Dina Hatem Elhammady at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina H. El-Hammady, MD (00201223971467, dinael_hammady73@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain Scores as measured by the Visual Analog Scale (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2016.