Pain intensity was measured using the Numeric Pain Scale (NPS; 0 = no pain, 10 = worst pain). Higher scores indicate worse pain. A "pain-6 temperature" was first identified (temperature that elicits NPS = 6).
Test stimulus: Pain-6 temperature applied for 30s; participants rated pain at 10, 20, and 30s. The test-stimulus score is the average of the three NPS ratings.
Conditioned stimulus: After 5 minutes, the left hand was immersed in 10-12°C water for 30s while the same pain-6 temperature was applied again. Pain was rated the same way, and the conditioned-stimulus score is the average of the
Participants first determined the temperature that elicited Numeric Pain Scale (NPS) = 6 ("pain-6"). Using this temperature, a train of 15 heat pulses (0.4 Hz) was delivered to the right forearm with a TSA-II thermode.
Pain was rated using the NPS after the 1st and 15th heat stimulus.
TSPS calculation:
TSPS = NPS rating after the 15th stimulus - NPS rating after the 1st stimulus. Higher TSPS values represent greater temporal pain summation (worse outcome).
Group
Value
95% CI
Active tDCS and Active Exercise
-0.11
-0.60 – 0.38
Sham tDCS and Active Exercise
0.48
-0.29 – 1.25
Active tDCS and Sham Exercise
0.47
-0.27 – 1.20
Sham TDCS and Sham Exercise
0.09
-0.44 – 0.61
Adverse events — posted to ClinicalTrials.gov
Time frame: 4.5 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07246993 — Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms
· NA
· recruiting
NCT07404319 — Effectiveness of Exercise Alone and tDCS+Exercise on Cognitive Function Improvement in Patients With Treatment Resistant
· NA
· not yet recruiting
NCT07212829 — The Added Value of Transcranial Direct Current Stimulation (tDCS) During Exercise for People With Chronic Widespread Pai
· NA
· not yet recruiting
NCT07202455 — Effect of Early Neuromodulation Coupled With Rehabilitation on the Prevention of Post-stroke Pain
· NA
· not yet recruiting
NCT06901687 — Home-Based Transcranial Direct Current Stimulation (tDCS) for Depression in Multiple Sclerosis (MS)
· Phase 2
· recruiting
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Currently open trials in the same condition.
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NCT07358754 — The Relationship Between Serum S100B and Brain-Derived Neurotrophic Factor
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NCT07465991 — The Effect of Digital Cognitive Behavioural Therapy for Insomnia on Physical Activity in Fibromyalgia
· NA
· recruiting
Other Spaulding Rehabilitation Hospital trials
Trials by the same sponsor.
NCT04940403 — BurtVision™ for Arm Rehabilitation in Chronic Stroke Survivors:
· NA
· not yet recruiting
NCT06193317 — Effects of taVNS on Fibromyalgia Pain
· NA
· not yet recruiting
NCT07483320 — Extracorporeal Shockwave Therapy and Platelet-Rich Plasma for Midportion Achilles Tendinopathy
· NA
· not yet recruiting
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· recruiting
NCT06826781 — Evaluating Q-Collar Effects on Brain Blood Flow Control During Exercise
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Spaulding Rehabilitation Hospital
Last refreshed: 10 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03371225.