Trial Summary
What is the purpose of this trial?This trial aims at understanding the mechanisms of optimized transcranial direct current stimulation (tDCS) (16 tDCS sessions combined with exercise)\] on pain control. Optimized tDCS can lead to stronger engagement of the endogenous pain regulatory system that will ultimately lead to increased pain relief in patients with fibromyalgia (FM). Therefore, the investigators designed a 2x2 factorial mechanistic trial \[tDCS (active and sham) and aerobic exercise (AE) (active and control)\] to evaluate the effects of 4 weeks of tDCS coupled with exercise on the endogenous pain regulatory system assessed by conditioned pain modulation (CPM) and central sensitization as assessed by temporal slow pain summation (TSPS), and compared to either intervention alone and to no intervention.
Eligibility Criteria
Adults aged 18-65 with fibromyalgia, experiencing pain for over 6 months and resistant to common painkillers. Participants must be able to feel touch on their forearm and provide informed consent. Excluded are those with unstable medical/psychiatric disorders, substance abuse history, significant neurological issues or surgeries, high opiate use, severe depression, or pregnancy.Inclusion Criteria
I have been diagnosed with fibromyalgia pain, lasting more than 6 months and averaging at least a 4 on the pain scale, with no other chronic pain conditions.
You need to be able to feel the touch of a special fiber on your forearm.
My pain doesn't improve with common painkillers like Tylenol or Ibuprofen.
+2 more
Exclusion Criteria
You are pregnant or could become pregnant.
You have used drugs or alcohol excessively in the past 6 months. If you say you have, we will check using specific criteria.
I am currently taking high doses of pain medication.
+5 more
Participant Groups
The trial is testing the combination of transcranial direct current stimulation (tDCS) and exercise on pain control in fibromyalgia patients. It will compare active tDCS with sham (placebo) tDCS and active exercise with sham exercise over four weeks to see which methods best engage the body's natural pain regulation.
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active tDCS and Active ExerciseExperimental Treatment2 Interventions
Active tDCS for 20 min Active exercise (60-70% max HR) for 30 min
Group II: Sham tDCS and Active ExerciseActive Control2 Interventions
Sham tDCS for 20 min Active exercise (60-70% max HR) for 30 min
Group III: Active tDCS and Sham ExerciseActive Control2 Interventions
Active tDCS for 20 min Sham exercise (within 10% baseline HR) for 30 min
Group IV: Sham TDCS and Sham ExercisePlacebo Group2 Interventions
Sham tDCS for 20 min Sham exercise (within 10% baseline HR) for 30 min
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Spaulding Rehabilitation Hospital for Continuing CareCambridge, MA
Spaulding Rehabilitation Network Research InstituteCharlestown, MA
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Who Is Running the Clinical Trial?
Spaulding Rehabilitation HospitalLead Sponsor