Research AppraisalRandomised Controlled Trial

Effect of photobiomodulation on pain and quality of life in fibromyalgia syndrome: a systematic review

Lasers in medical scienceG A, Swathi, Maiya, G Arun, Shetty, Shiran et al.23 June 2026DOI

Clinical Snapshot

60CEBM
Evidence: WeakRandomised Controlled Trial

PICO Framework

P — PopulationAdults diagnosed with Fibromyalgia Syndrome (FMS) characterised by widespread chronic pain and central sensitisation
I — InterventionPhotobiomodulation therapy (PBMT), also referred to as low-level laser/light therapy (LLLT), as a non-pharmacological treatment modality
C — ComparatorPlacebo/sham PBMT, usual care, or other active comparators as reported in included randomised controlled trials
O — OutcomesPrimary: pain intensity reduction; Secondary: quality of life (QoL), sleep quality, psychological well-being

Bottom Line

This systematic review synthesises evidence from seven RCTs examining photobiomodulation therapy (PBMT) for fibromyalgia syndrome. While the review is methodologically sound in its design — with PROSPERO registration, PRISMA adherence, and RoB 2.0 quality assessment — the evidence base is critically limited. Only seven trials were identified, no meta-analysis was possible due to substantial heterogeneity, and no GRADE assessment was performed. The narrative synthesis suggests consistent short-term improvements in pain intensity and quality of life, with additional signals for sleep and psychological well-being. However, without pooled effect sizes, confidence intervals, or sensitivity analyses, the magnitude and durability of these effects cannot be determined. For Australian clinicians, PBMT cannot currently be recommended as a standard component of FMS management. It may be considered as an investigational adjunct within a multidisciplinary pain program for patients with refractory symptoms, provided informed consent is obtained. The authors' call for large-scale, standardised RCTs is well-founded and essential before PBMT can be integrated into evidence-based FMS guidelines.

Evidence: Weak

Key Findings

  • P Value: Not reported at the review level; individual trial-level statistics not summarised in abstract

  • Effect Size: Not quantified — no meta-analysis performed; direction of effect consistently favours PBMT over comparator for pain reduction and QoL improvement

  • Primary Outcome: Consistent short-term reductions in pain intensity across included RCTs, as assessed by narrative synthesis of seven randomised controlled trials

  • Nnt Or Sensitivity: NNT not calculable from available data; no sensitivity analyses reported; PBMT described as demonstrating additional benefits for sleep quality and psychological well-being beyond pain reduction

  • Confidence Interval: Not reported — absence of pooled analysis precludes confidence interval estimation

Clinical Application

PBMT devices are available in physiotherapy and pain management settings in Australia, though standardised treatment protocols for FMS are not yet established. The therapy is non-invasive, generally well-tolerated, and does not require pharmacological prescribing. However, cost, access, and lack of Medicare Benefits Schedule (MBS) rebate for PBMT in FMS represent practical barriers. Treatment parameters (wavelength, dose, frequency) remain unstandardised, complicating implementation. In Australia, FMS management aligns with RACGP guidelines emphasising a biopsychosocial, multidisciplinary approach incorporating exercise, cognitive behavioural therapy, sleep hygiene, and judicious pharmacotherapy (e.g., low-dose amitriptyline, duloxetine, pregabalin — noting pregabalin is PBS-listed for FMS under Section 85). PBMT is not currently endorsed in RACGP or Australian Pain Society guidelines for FMS. The TGA regulates PBMT devices as Class IIa medical devices, but clinical indication-specific approval for FMS does not exist. Given the current evidence base, PBMT should be considered only as an investigational adjunct within a structured multidisciplinary pain program, not as a standalone or first-line therapy. Australian physiotherapists and pain specialists considering PBMT should document treatment rationale, obtain informed consent regarding experimental status, and ideally enrol patients in prospective registries or clinical trials to contribute to the evidence base. Adults with diagnosed Fibromyalgia Syndrome (meeting ACR 2010/2016 diagnostic criteria) who have not achieved adequate symptom control with first-line pharmacological and non-pharmacological therapies, and who are seeking adjunctive non-pharmacological pain management options

Abstract

Fibromyalgia Syndrome (FMS) is a chronic pain disorder characterized by widespread pain and central sensitization that significantly impacts the quality of life (QoL). For management to be effective, a multidisciplinary approach to care is typically required. Photobiomodulation therapy (PBMT), a non-pharmacological treatment, has garnered attention lately, though its clinical relevance and applications are not well defined. The objective of this review was to assess the effectiveness of PBMT in reducing FMS symptoms. This systematic review was registered at PROSPERO (CRD420251084730) and conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guidelines. A total of seven randomized controlled trials were identified following an extensive literature search across various databases, including PubMed, Scopus, Web of Science, the Cochrane Library, Embase, Ovid and ProQuest. To evaluate the methodological quality of these studies, the Cochrane Risk of Bias (RoB 2.0) tool was applied. PBMT demonstrated consistent short-term reductions in pain intensity and improvements in QoL. Additional positive effects on sleep quality and psychological well-being were observed, indicating that PBMT may provide additional therapeutic benefits beyond pain reduction, including improvements in sleep quality and psychological well-being. PBMT has shown promise as a safe, non-pharmacological adjunct therapy that may provide short-term improvements in pain levels and QoL, but substantial heterogeneity limits generalizability. Clinical trials with large samples and standardized methodologies should be conducted to better clarify the role of PBMT in multidisciplinary therapy for FMS.

References

  1. 1.G A, Swathi, Maiya, G. A., Shetty, S., Abrahamse, H., Kadavigere, R., Bhat N, S., & K N, Shivashankara. (2026). Effect of photobiomodulation on pain and quality of life in fibromyalgia syndrome: a systematic review. Lasers in Medical Science. https://doi.org/10.1136/acupmed-2015-011036
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