Trial Outcomes & Findings for Randomized Controlled Trial of CES for Fibromyalgia (NCT NCT04115033)

Veterans were recruited through direct referrals from Atlanta VA Healthcare System physicians, and through letters and phone calls inviting them to participate following a data access request through the VA corporate data warehouse based on a diagnosis of fibromyalgia and other characteristics matching inclusion criteria for the study.

A total of 50 participants were consented for this study. Two of these participants could not begin the study due to MRI-incompatible medical device/metal implants. These two individuals were excluded from the study after initial consent and prior to randomization. A total of 48 participants were randomly allocated to treatment groups.

Randomized Controlled Trial of CES for Fibromyalgia

For subjects with fibromyalgia, clinical pain was assessed in both groups using the Defense Veterans Pain Rating Scale (DVPRS), a validated measurement tool for pain, as well as analgesic consumption. Clinical pain was measured at baseline, 6 weeks following treatment, and 12 weeks following treatment completion in both groups. Mean differences were measured between the baseline score and the 12-week score. The DVPRS is a combination of several different pain scales including the VAS, verbal rating scale, FACES scale, and numerical rating scale. Measurements will be graded on a scale of 0-10 with 0 being "no pain" and 10 being "severe" or "worst pain."

The region of interest (ROI) was the right Cerebellar 7b seed, and a 2x2 mixed ANOVA interaction was conducted with Family -Wise Error (FWE) constraints to control for multiple comparisons. Voxel threshold was set to p\<0.005 uncorrected, cluster threshold of p\<0.05 FWE corrected. A Fisher-transform z-score represents the mean connectivity values for each covariate in the model (i.e. groups) for each significant cluster. A z-score value of 0 indicates no difference in functional connectivity. Positive z-scores denote stronger, and negative z-scores weaker, connectivity with the ROI; further research is needed to determine their clinical implications and whether these changes denote a positive or negative outcome.

Tests of function (sit-to-stand, bicep curl, handgrip strength) was performed in both groups at baseline, 6 weeks, and 12 weeks following treatment. Mean difference was measured between baseline and 12 weeks. The sit-to-stand test tests how many full sit-to-stands a subject can perform within a 30 second interval.

Tests of function (sit-to-stand, bicep curl, handgrip strength) was performed in both groups at baseline, 6 weeks, and 12 weeks following treatment. Mean difference was measured between baseline and 12 weeks. The bicep curl tests how many full bicep curls with gender specific weights (8 pounds for male, 5 pounds for female) a subject can perform within a 30 second interval. Both arms were tested.

Tests of function (sit-to-stand, bicep curl, handgrip strength) was performed in both groups at baseline, 6 weeks, and 12 weeks following treatment. Mean difference was measured between baseline and 12 weeks. The handgrip strength test uses a dynamometer to gauge the pressure that a subject can apply with their handgrip. Both hands were tested.

NIH Patient-Reported Outcomes Measurement Information System (PROMIS) measures were assessed using a validated survey created from independently validated NIH survey questions in both groups. Mean differences in T-scores were measured between the baseline visit and the 12-week visit. PROMIS measures included: PROMIS Item Bank v1.0 - Fatigue - Short Form 6a, PROMIS Item Bank v1.0 - Emotional Distress-Depression - Short Form 4a, PROMIS Item Bank v.1.0 - Emotional Distress - Anxiety- Short Form 7a. For each measure, a lower T-score represents a better clinical outcome. All of the PROMIS measures reported (Fatigue, Depression, and Anxiety) have been standardized to have a mean of 50 and an SD of 10. This standardization means that a score of 50 is the average level in the population, and any 10-point change in either direction (greater or lesser) represents one SD difference.