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Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT01598181
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : February 16, 2017
Sponsor:
Collaborator:
Stiftelsen Helse og Rehabilitering
Information provided by (Responsible Party):
University Hospital of North Norway

Brief Summary:
The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: tDCS NeuroConn DC-stimulator plus Device: sham tDCS Not Applicable

Detailed Description:

Fibromyalgia (FIM) is a chronic pain condition with high prevalence. Studies involving neuroimaging techniques have identified functional differences in cerebral pain processing in patients with FIM, as compared to healthy controls. This may support that FIM do have a functional CNS component.

Transcranial Direct Current Stimulation (tDCS) is a non-invasive and safe method for inducing changes in cortical excitability. Previous studies showed that anodal stimulation of M1 may change pain perception, possibly by modulating functional anomalies in the FIM brain. The present study has two main goals:

  1. To investigate if tDCS may provide FIM patients with symptom relief due to reduction of pain.
  2. To investigate tDCS induced functional changes in the brain by using fMRI.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) as Treatment Method for Pain in Fibromyalgia
Study Start Date : December 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: active tDCS Device: tDCS NeuroConn DC-stimulator plus
Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.
Other Names:
  • model 0021
  • serial-no 0337

Sham Comparator: sham tDCS
tDCS fades out after 20 sec. administered double blind by coded program.
Device: tDCS NeuroConn DC-stimulator plus
Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.
Other Names:
  • model 0021
  • serial-no 0337

Device: sham tDCS
similar montage and time as active. Stimulation fades out after 20 sec.




Primary Outcome Measures :
  1. Perceived pain [ Time Frame: Change in VAS from baseline up to 49 days. ]
    Pain (intensity and unpleasentness) measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\sham tDCS on pain. 2 levels of group (active tDCS\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) SMS messages contain 4 questions, mesauring pain intensity / pain unpleasentness (primary outcome), and stress / activation (secondary outcome).


Secondary Outcome Measures :
  1. Cerebral pain processing [ Time Frame: Change from baseline to post treatment. 7 days. ]
    Phillps tesla 1.5 fMRi, pathway pain stimulator (Medoc, Israel) fMRI under pain stimulation for 60 participants. 20 recieve active tDCS, 20 recieve sham-tDCS, 20 age and gender matched (matched to active tDCS group) healthy controls. Baseline scan, post treatment scan.

  2. Rating scales (HADS, SCL90, SF36, FIQ) [ Time Frame: Change from baseline to post treatment. 30 days post treatment. Up to 65 days. ]
    Time from inclusion to treatment start determines 30\14 days. Rating scales on Samsung Galaxy tab 10.1. HADS mesure anxiety and depression, SCL 90 measure symtoms of mental illness, SF36 mesure health related life quality, FIQ mesure symptom severity in fibromyalgia.

  3. Perceived pain, natural history [ Time Frame: Baseline compared to post-treatment. Up to 65 days ]
    Pain (intensity and unpleasentness) measured with Visual Analog Scale. 3 times daily (0900hrs, 1500hrs, 2100hrs). A randomly selected sample of participants have VAS measured with SMS for 30 days pre treatment. Intention is to gather natural history sample to compare with a similarly lengthed post-treatment period.

  4. Perceived stress and activation [ Time Frame: Change in VAS from baseline to during treatment and after treatment. Up to 49 days. ]
    Stress and activation measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\sham tDCS on stress and activation. 2 levels of group (active tDCS\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) Measured using the same instrumet as the primary outcome.

  5. Perceived stress and activation, natural history [ Time Frame: Baseline compared to post-treatment. Up to 65 days ]
    Stress and activation measured with Visual Analog Scale. 3 times daily (0900hrs, 1500hrs, 2100hrs). A randomly selected sample of participants have VAS measured with SMS for 30 days pre treatment. Intention is to gather natural history sample to compare with a similarly lengthed post-treatment period.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fibromyalgia (ACR-90 criteria, M79.7 ICD10)
  • Mean VAS > 4 daily 2 weeks prior to study).

Exclusion Criteria:

  • Severe mental disease
  • CNS disease
  • Mental retardation
  • Age < 18

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): NCT01598181


Locations
Norway
University Hospital of North Norway
Tromsoe, Norway, 9038
Sponsors and Collaborators
University Hospital of North Norway
Stiftelsen Helse og Rehabilitering
Investigators
Study Chair: Per Aslaksen, ph.d University of Tromso

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01598181     History of Changes
Other Study ID Numbers: 2010/2256/REK n
UNorthNorway ( Other Grant/Funding Number: UNorthNorway )
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: June 2016

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases