N/A
Completed N=116
Optimized tDCS for Fibromyalgia: Targeting the Endogenous Pain Control System
Source: ClinicalTrials.gov NCT03371225 ↗Enrolled (actual)
116
Serious AEs
0.9%
Results posted
Dec 2025
Primary outcomePrimary: Conditioning Pain Modulation (CPM) — 0.36; 0.05; 0.21; -0.55 Unit on a scale (NPS 0-10)
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Conditioning Pain Modulation (CPM) |
0.36; 0.05; 0.21; -0.55 | — |
| PRIMARY Temporal Slow Pain Summation (TSPS) |
-0.11; 0.48; 0.47; 0.09 | — |
Eligibility Criteria
Inclusion Criteria
- Age range 18-65 years,
- Diagnosis of FM pain according to the ACR 2010 criteria (existing pain for more than 6 months with an average of at least 4 on a 0-10 VAS scale) without other comorbid chronic pain diagnosis,
- Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine,
- Must have the ability to feel sensation by Von-Frey fiber on the forearm,
- Able to provide informed consent to participate in the study.
Exclusion Criteria
- Clinically significant or unstable medical or psychiatric disorder,
- history of substance abuse within the past 6 months as self-reported (if subject reports a history of substance abuse, we will confirm using DSM V criteria),
- Previous significant neurological history (e.g., traumatic brain injury), resulting in neurological deficits, such as cognitive or motor deficits, as self-reported,
- Previous neurosurgical procedure with craniotomy,
- Severe depression (If a patient scores >30 on the Beck Depression Inventory, one will obtain clearance. If one does not pass the medical clearance, one will not be included in the study)
- Pregnancy (as the safety of tDCS in pregnant population (and children) has not been assessed (though risk is non-significant), the investigators will exclude pregnant women (and children). Women of child-bearing potential will be required to take a urine pregnancy test during the screening process and at every week of stimulation),
- Current opiate use in large doses (more than 30mg of oxycodone/hydrocodone or 7.5mg of hydromorphone (Dilaudid) or equivalent),
- Patients will be excluded when they have increased risk for exercise
Data sourced from ClinicalTrials.gov (NCT03371225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.