ORIGINAL ARTICLE   Open access

European Journal of Physical and Rehabilitation Medicine 2023 December;59(6):754-62

DOI: 10.23736/S1973-9087.23.07928-5

Copyright © 2023 THE AUTHORS

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lingua: Inglese

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

Neide F. RIBEIRO ¹, Ernesto C. P. LEAL-JUNIOR ^{1, 2, 3} ✉, Douglas S. JOHNSON ⁴, Timothy DEMCHAK ⁵, Caroline M. MACHADO ¹, Luana B. DIAS ¹, Marcelo F. DE OLIVEIRA ¹, Matheus M. LINO ¹, Wesley D. RODRIGUES ¹, Jonathan SANTO ¹, Carolina N. DE BARROS ¹, Heliodora L. CASALECHI ¹, Shaiane S. TOMAZONI ²

¹ Post-Graduate Program in Rehabilitation Sciences, Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Nove de Julho University, São Paulo, Brazil; ² Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway; ³ ELJ Consultancy, São Paulo, Brazil; ⁴ Multi-Radiance Medical, Solon, OH, USA; ⁵ Indiana State University, Terre Haute, IN, USA

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.

KEY WORDS: Fibromyalgia; Low-level light therapy; Rheumatic diseases, Rehabilitation; Physical therapy modalities