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

BACKGROUND

Patients with fibromyalgia experience chronic, widespread pain. It remains a misunderstood disorder with multimodal treatments providing mixed results.

OBJECTIVES

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.

METHODS

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.

RESULTS

There were no statistically significant differences in the BSS for hypermobility (p = .21; d = .74), PCS (p = .70; d = .22), VAS (p = .17-.61; d = .20-.83) scores, QST for skin temperature and stimuli (p = .14-.65; d = .25-.88), and for the pressure pain threshold (p = .71-.93; d = .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.

CONCLUSION

RSWT was implemented safely, without any negative treatment effects reported, and acted as a pain modulator to reduce sensitivity.

CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identification number NCT02760212.