Photobiomodulation therapy combined with static magnetic field is better than placebo in patients with fibromyalgia: a randomized placebo-controlled trial.

BACKGROUND

Fibromyalgia is a syndrome characterized by generalized chronic pain and tenderness in specific areas. Photobiomodulation therapy (PBMT) using low-level laser therapy and/or light emitting diode therapy is an electrophysical agent that can be used alone or together with a static magnetic field (PBMT-sMF) to promote analgesia in several health conditions. Little evidence exists regarding the effects of using PBMT and PBMT-sMF in patients with fibromyalgia; this evidence is conflicting.

AIM

We aimed to investigate the effects of using PBMT-sMF versus a placebo on reduction of the degree-of-pain rating, impact of fibromyalgia, pain intensity, and satisfaction with treatment in patients with fibromyalgia.

DESIGN

A prospectively registered, monocentric, randomized placebo-controlled trial, with blinding of patients, therapists, and assessors, was performed.

SETTING

The study was conducted at the Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT) in Brazil, between March and October 2020.

POPULATION

Ninety female patients with fibromyalgia were randomized to undergo either PBMT-sMF (N.=45) or placebo (N.=45) treatment.

METHODS

Patients from both groups received nine treatment sessions, three times a week, for 3 weeks. Clinical outcomes were collected at baseline, the end of treatment, and at the follow-up appointment 4 weeks post-treatment. The primary outcome was the degree-of-pain rating, measured by the reduction of the tender point count.

RESULTS

A decrease in the degree-of-pain rating was observed in patients allocated to the PBMT-sMF group, decreasing the number of tender points when compared to placebo group at the end of treatment (P<0.0001) and at the follow-up assessment (P<0.0001). Patients did not report any adverse events.

CONCLUSIONS

PBMT-sMF is superior to placebo, supporting its use in patients with fibromyalgia.

CLINICAL REHABILITATION IMPACT

PBMT-sMF might be considered an important adjuvant to the treatment regimens of patients with fibromyalgia.