IntroductionChronic pain conditions are a leading cause of disease and disability. They are associated with symptoms such as fatigue, sleep and mood disturbances. Minimal evidence is available to support effective treatments and alternatives treatment approaches are called for. Photobiomodulation therapy has been highlighted as one promising option. A whole-body therapy device (NovoTHOR) has recently been developed with a number of potential advantages for people with chronic pain. Research is needed to consider the feasibility of this device.Methods and analysisA single-centre single-armed (no placebo group) feasibility study with an embedded qualitative component will be conducted. The intervention will comprise 18 treatments over 6 weeks, with 6-month follow-up, in the whole-body photobiomodulation device. A non-probability sample of 20 adult participants with a clinician diagnosis of chronic axial pain, polyarthralgia, myofascial pain or widespread pain will be recruited (self-referral and clinician referral). Outcome measures will focus on acceptability of trial processes with a view to guiding a definitive randomised controlled trial. Analyses will use descriptive statistics for quantitative aspects. The qualitative element will be assessed by means of a participant-reported experience questionnaire postintervention and semistructured audio-recorded interviews at three stages; preintervention, midintervention and postintervention. The latter will be transcribed verbatim and a reflexive thematic analysis will be used to identify emerging themes. Exploratory outcomes (participant-reported and performance-based measures) will be analysed according to data distribution.Ethics and disseminationThe study has received ethical approval from the Leicester Central Research and Ethics Committee. Findings will be disseminated via local chronic pain groups, public register update, submission for presentation at scientific meetings and open-access peer-reviewed journals, and via academic social networks.Trial registration numberNCT05069363.
Background 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. Methods A single-arm feasibility study was conducted in accordance to 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 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 (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. Results 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. Conclusions 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. Trial Registration ClinicalTrials.gov trial; NCT05069363, 06/10/2021
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