Shockwave therapy and fibromyalgia and its effect on pain, blood markers, imaging, and participant experience - a multidisciplinary randomized controlled trial.

BackgroundObjectivesMethodsResultsConclusionClinical Trials RegistrationPatients with fibromyalgia experience chronic, widespread pain. It remains a misunderstood disorder with multimodal treatments providing mixed results.To examine the effects of radial shockwave therapy (RSWT) compared to placebo on pain, pain catastrophizing, psychological indices, blood markers, and neuroimaging. Study-related experiences were also explored qualitatively.Quantitative sensory testing (QST), Visual Analog Scale (VAS), Beighton Scoring Screen (BSS), Pain Catastrophizing Scale (PCS), blood biomarker (Interleukin (IL)-6 and IL-10), and brain fMRI were measured pre- and post-treatment along with a post-treatment survey. The RSWT group received five treatments (one week apart over five-week period) to the three most painful areas (500 shocks at 1.5 bar and 15 Hz, then 1000 shocks at 2 bar and 8 Hz, and finally 500 shocks at 1.5 bar and 15 Hz) versus sham treatment for the placebo group.There were no statistically significant differences in the BSS for hypermobility (<italic>p</italic> = .21; <italic>d</italic> = .74), PCS (<italic>p</italic> = .70; <italic>d</italic> = .22), VAS (<italic>p = .17–.61</italic>; <italic>d</italic> = .20–.83) scores, QST for skin temperature and stimuli (<italic>p = .14–.65</italic>; <italic>d</italic> = .25–.88), and for the pressure pain threshold (<italic>p = .71–.93</italic>; <italic>d</italic> = .05–.21). The VAS scores had clinically significant changes (MCID greater than 13.90) with improved pain scores in the RSWT group. Neuroimaging scans revealed no cortical thickness changes. Post-treatment surveys revealed pain and symptom improvements and offered hope to individuals.RSWT was implemented safely, without any negative treatment effects reported, and acted as a pain modulator to reduce sensitivity.ClinicalTrials.gov identification number NCT02760212 [ABSTRACT FROM AUTHOR]