Whole-Body Photobiomodulation Therapy for Fibromyalgia: A Feasibility Trial

Effective treatment for fibromyalgia (FM) is lacking and further treatment options are needed. Photobiomodulation therapy (PBMT) represents one potential treatment option. Whilst favourable findings have been reported using localised PBMT, no investigations have established the value of whole-body PBMT for the complete set of symptom domains in FM. A single-arm feasibility study was conducted in accordance to CONSORT guidelines. A non- probability sampling method was used to access individuals with FM. The primary outcome measure was identified as the Revised Fibromyalgia Impact Questionnaire (FIQR). Forty-nine participants were screened and 21 trial participants entered the trial. Nineteen participants completed the intervention (18 whole-body PBMT sessions over approximately six weeks). Descriptive statistics and qualitative analysis was undertaken to represent feasibility outcomes. Acceptability of the trial device and processes were established. Outcome measures towards efficacy data were guided by core and peripheral OMERACT domains, utilising a combination of participant-reported and performance-based outcome measures. Positive changes were observed for FM-specific quality of life, pain, tenderness, stiffness, fatigue, sleep disturbance, anxiety, depression and cognitive impairment. Patient global assessment revealed improvements at 6 weeks, with continued effect at 24 weeks. FM- specific quality of life at 24 weeks remained improved compared with baseline scores. Data for the embedded qualitative component of the trial were captured by participant-reported experience measures and audio-recorded semi-structured interviews. Findings provide evidence to support a full-scale trial and shows promise regarding potential efficacy of this novel non-invasive treatment in an FM population. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT05069363 ### Clinical Protocols ### Funding Statement This study did not receive any funding. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethics approval was granted by the Health Research Authority (HRA) and Health and Care Research Wales (HCRW) (278452) and Leicester Central Research and Ethics Committee (21/EM/0231) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors.