Whole-Body Photobiomodulation Therapy for Fibromyalgia: A Feasibility Trial

Abstract

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 with CONSORT (Consolidated Standards of Reporting Trials) 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 twenty-one 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 (outcomes measures in rheumatological clinical trials) domains, utilising a combination of participant-reported and performance-based outcome measures. Data for the embedded qualitative component of the trial were captured by participant-reported experience measures and audio-recorded semi-structured interviews. 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. The findings provided evidence to support a full-scale trial and showed promise regarding potential efficacy of this novel non-invasive treatment in an FM population.

Keywords: chronic primary widespread pain; feasibility trial; fibromyalgia; photobiomodulation therapy; whole-body.

Figure 1

NovoTHOR^® whole-body PBMT device. Reprinted with permission from THOR Photomedicine Ltd. [38], 2019–2023, THOR Photomedicine, novothor.com (accessed on 8 December 2021).

Figure 2

OMERACT hierarchy of domains. Reproduced with permission from OMERACT Fibromyalgia Working Group [42], 2023, OMERACT, www.omeract.org (accessed on 26 January 2021).

Figure 3

CONSORT study flow diagram.

Figure 4

CONSORT Flow Diagram.

Figure 5

Participant experience of trial device.

Figure 6

Box and whisker plots demonstrating improvements following trial intervention for all outcome measures. Blue denotes participant-reported outcome measures. Green denotes performance-based outcome measures.

Figure 7

Mean FIQR scores (y-axis) with 95% Confidence Intervals, at specified timepoints (x-axis).

Figure 8

Manual Tender Point Survey score (y-axis) versus pressure tolerated (x-axis), representing an average score for tender point across anatomical location. Each diamond represents one of the 18 anatomical locations. y-axis demonstrates total sum of MTPS (Manual Tender Point Survey) scores for each tender point. x-axis shows total pressure tolerated for each tender point. Blue diamonds represent scores for each tender point pre-treatment. Red diamonds represent scores post-treatment. Dotted lines depict correlations.

Figure 9

Percentage change in pressure and pain scores for each participant. y-axis describes percentage change in total pressure tolerated post-treatment at week 6. x-axis describes percentage change in MTPS (Manual Tender Point Survey) scores post-treatment. Each dot denotes an individual participant.