Whole-body photobiomodulation therapy for chronic pain: a protocol for a feasibility trial

Bethany Fitzmaurice, Nicola R Heneghan, Asius Rayen, Andrew Soundy, Bethany Fitzmaurice, Nicola R Heneghan, Asius Rayen, Andrew Soundy

Abstract

Introduction: Chronic 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 analysis: A 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 dissemination: The 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 number: NCT05069363.

Keywords: musculoskeletal disorders; pain management; rheumatology.

Conflict of interest statement

Competing interests: THOR are providing in-kind sponsorship. They are not providing any other funding or sponsorship. They will not have the final decision over study design, conduct, access to data set, analyses, interpretation of data, manuscript writing or results dissemination.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
NovoTHOR. Reprinted with permission.
Figure 2
Figure 2
OMERACT hierarchy of domains. Reprinted with permission. The innermost circle contains the core set of domains to be assessed in all clinical trials of FM. The second concentric circle includes the outer core set of domains to be assessed in some but not all FM trials. The outermost circle includes the domains on the research agenda that may or may not be included in FM trials. FM, fibromyalgia.
Figure 3
Figure 3
CONSORT study flow diagram. CONSORT, Consolidated Standards of Reporting Trials.

References

    1. Raja SN, Carr DB, Cohen M, et al. . The revised international association for the study of pain definition of pain: concepts, challenges, and compromises. Pain 2020;161:1976–82. 10.1097/j.pain.0000000000001939
    1. Treede R-D, Rief W, Barke A, et al. . A classification of chronic pain for ICD-11. Pain 2015;156:1003–7. 10.1097/j.pain.0000000000000160
    1. Meints SM, Edwards RR. Evaluating psychosocial contributions to chronic pain outcomes. Prog Neuropsychopharmacol Biol Psychiatry 2018;87:168–82. 10.1016/j.pnpbp.2018.01.017
    1. Treede R-D, Rief W, Barke A, et al. . Chronic pain as a symptom or a disease: the IASP classification of chronic pain for the International classification of diseases (ICD-11). Pain 2019;160:19–27. 10.1097/j.pain.0000000000001384
    1. Mills SEE, Nicolson KP, Smith BH. Chronic pain: a review of its epidemiology and associated factors in population-based studies. Br J Anaesth 2019;123:e273–83. 10.1016/j.bja.2019.03.023
    1. GBD 2019 Diseases and Injuries Collaborators . Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the global burden of disease study 2019. Lancet 2020;396:1204–22. 10.1016/S0140-6736(20)30925-9
    1. El-Metwally A, Shaikh Q, Aldiab A, et al. . The prevalence of chronic pain and its associated factors among Saudi Al-Kharj population; a cross sectional study. BMC Musculoskelet Disord 2019;20:177. 10.1186/s12891-019-2555-7
    1. Kia S, Choy E. Update on treatment guideline in fibromyalgia syndrome with focus on pharmacology. Biomedicines 2017;5:20. 10.3390/biomedicines5020020
    1. Taylor R, Pergolizzi JV, Puenpatom RA, et al. . Economic implications of potential drug–drug interactions in chronic pain patients. Expert Rev Pharmacoeconomics Outcomes Res 2013;13:725–34.
    1. Kisselev SB, Moskvin SV. The use of laser therapy for patients with fibromyalgia: a critical literary review. J Lasers Med Sci 2019;10:12–20. 10.15171/jlms.2019.02
    1. National Institute for Health and Care Excellence . Chronic pain (primary and secondary) in over 16s: assessment of all chronic pain and management of chronic primary pain NICE guideline [NG193], 2021. Available: [Accessed 24 May 2021].
    1. Taulaniemi A, Kankaanpää M, Rinne M, et al. . Fear-avoidance beliefs are associated with exercise adherence: secondary analysis of a randomised controlled trial (RCT) among female healthcare workers with recurrent low back pain. BMC Sports Sci Med Rehabil 2020;12:28. 10.1186/s13102-020-00177-w
    1. Mc Veigh JG, Lucas A, Hurley DA, et al. . Patients’ perceptions of exercise therapy in the treatment of fibromyalgia syndrome: a survey. Musculoskeletal Care 2003;1:98–107. 10.1002/msc.45
    1. Jack K, McLean SM, Moffett JK, et al. . Barriers to treatment adherence in physiotherapy outpatient clinics: a systematic review. Man Ther 2010;15:220–8. 10.1016/j.math.2009.12.004
    1. National Institute for Health and Care Excellence . Commonly used treatments for chronic pain can do more harm than good and should not be used, says NICE in draft guidance, 2020. Available: [Accessed 2 Aug 2021].
    1. National Institute for Health and Care Excellence . Low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy (Interventional procedures guidance [IPG615]), 2018. Available: [Accessed 18 Jul 2020].
    1. Chung H, Dai T, Sharma SK, et al. . The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng 2012;40:516–33. 10.1007/s10439-011-0454-7
    1. Farivar S, Malekshahabi T, Shiari R. Biological effects of low level laser therapy. J Lasers Med Sci 2014;5:58–62.
    1. Clijsen R, Brunner A, Barbero M, et al. . Effects of low-level laser therapy on pain in patients with musculoskeletal disorders: a systematic review and meta-analysis. Eur J Phys Rehabil Med 2017;53:603–10. 10.23736/S1973-9087.17.04432-X
    1. International Association for the Study of Pain . Myofascial pain [fact sheet] (revised 2017), 2010. Available: [Accessed 5 Jul 2020].
    1. Chow RT, Johnson MI, Lopes-Martins RAB, et al. . Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet 2009;374:1897–908. 10.1016/S0140-6736(09)61522-1
    1. Haldeman S, Carroll L, Cassidy JD, et al. . The bone and joint decade 2000–2010 Task force on neck pain and its associated disorders. Spine 2008;33:S5–7. 10.1097/BRS.0b013e3181643f40
    1. Maia MLdeM, Bonjardim LR, Quintans JdeSS, et al. . Effect of low-level laser therapy on pain levels in patients with temporomandibular disorders: a systematic review. J Appl Oral Sci 2012;20:594–602. 10.1590/s1678-77572012000600002
    1. Bisset L, Coombes B, Vicenzino B. Tennis elbow. BMJ Clin Evid 2011;2011:1117.
    1. Favejee MM, Huisstede BMA, Koes BW. Frozen shoulder: the effectiveness of conservative and surgical interventions-systematic review. Br J Sports Med 2011;45:49–56. 10.1136/bjsm.2010.071431
    1. Glazov G, Yelland M, Emery J. Low-level laser therapy for chronic non-specific low back pain: a meta-analysis of randomised controlled trials. Acupunct Med 2016;34:328–41. 10.1136/acupmed-2015-011036
    1. Qaseem A, Wilt TJ, McLean RM, et al. . Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of physicians. Ann Intern Med 2017;166:514–30. 10.7326/M16-2367
    1. Rayegani SM, Raeissadat SA, Heidari S, et al. . Safety and effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis. J Lasers Med Sci 2017;8:S12–19. 10.15171/jlms.2017.s3
    1. Deana NF, Zaror C, Sandoval P, et al. . Effectiveness of low-level laser therapy in reducing orthodontic pain: a systematic review and meta-analysis. Pain Res Manag 2017;2017:8560652. 10.1155/2017/8560652
    1. de Andrade ALM, Bossini PS, Parizotto NA. Use of low level laser therapy to control neuropathic pain: a systematic review. J Photochem Photobiol B 2016;164:36–42. 10.1016/j.jphotobiol.2016.08.025
    1. Huisstede BM, Hoogvliet P, Franke TP, et al. . Carpal tunnel syndrome: effectiveness of physical therapy and Electrophysical modalities. An updated systematic review of randomized controlled trials. Arch Phys Med Rehabil 2018;99:1623–34. 10.1016/j.apmr.2017.08.482
    1. Carcia CR, Martin RL, Houck J, et al. . Achilles pain, stiffness, and muscle power deficits: Achilles tendinitis. J Orthop Sports Phys Ther 2010;40:A1–26. 10.2519/jospt.2010.0305
    1. Zadik Y, Arany PR, Fregnani ER, et al. . Systematic review of photobiomodulation for the management of oral mucositis in cancer patients and clinical practice guidelines. Support Care Cancer 2019;27:3969–39. 10.1007/s00520-019-04890-2
    1. Gonzalez-Lima F, Barrett DW. Augmentation of cognitive brain functions with transcranial lasers. Front Syst Neurosci 2014;8:36. 10.3389/fnsys.2014.00036
    1. Mease P, Arnold LM, Choy EH, et al. . Fibromyalgia syndrome module at OMERACT 9: domain construct. J Rheumatol 2009;36:2318–29. 10.3899/jrheum.090367
    1. Eldridge SM, Chan CL, Campbell MJ, et al. . CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016;355:i5239. 10.1136/bmj.i5239
    1. Calvert M, King M, Mercieca-Bebber R, et al. . SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials. BMJ Open 2021;11:e045105. 10.1136/bmjopen-2020-045105
    1. Ruaro JA, Fréz AR, Ruaro MB, et al. . Low-level laser therapy to treat fibromyalgia. Lasers Med Sci 2014;29:1815–9. 10.1007/s10103-014-1566-8
    1. Gür A, Karakoc M, Nas K, et al. . Effects of low power laser and low dose amitriptyline therapy on clinical symptoms and quality of life in fibromyalgia: a single-blind, placebo-controlled trial. Rheumatol Int 2002;22:188–93. 10.1007/s00296-002-0221-z
    1. Tomazoni SS, Costa LdaCM, Guimarães LdeS, et al. . Effects of photobiomodulation therapy in patients with chronic non-specific low back pain: protocol for a randomised placebo-controlled trial. BMJ Open 2017;7:e017202. 10.1136/bmjopen-2017-017202
    1. de Carvalho PdeTC, Leal-Junior ECP, Alves ACA, et al. . Effect of low-level laser therapy on pain, quality of life and sleep in patients with fibromyalgia: study protocol for a double-blinded randomized controlled trial. Trials 2012;13:221. 10.1186/1745-6215-13-221
    1. da Silva MM, Albertini R, de Tarso Camillo de Carvalho P, et al. . Randomized, blinded, controlled trial on effectiveness of photobiomodulation therapy and exercise training in the fibromyalgia treatment. Lasers Med Sci 2018;33:343–51. 10.1007/s10103-017-2388-2
    1. Lopes-Martins RAB, Albertini R, Lopes-Martins PSL. Steroids block the anti-inflammatory effects of low level laser therapy. In: Hamblin MR, Waynant RW, Anders J, eds. Mechanisms for low-light therapy, 2006: 98–103.
    1. Hoffmann TC, Glasziou PP, Boutron I, et al. . Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687. 10.1136/bmj.g1687
    1. Yeh S-W, Hong C-H, Shih M-C, et al. . Low-level laser therapy for fibromyalgia: a systematic review and meta-analysis. Pain Physician 2019;22:241–54.
    1. Moore CG, Carter RE, Nietert PJ, et al. . Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci 2011;4:332–7. 10.1111/j.1752-8062.2011.00347.x
    1. Lancaster GA, Thabane L. Guidelines for reporting non-randomised pilot and feasibility studies. Pilot Feasibility Stud 2019;5:114. 10.1186/s40814-019-0499-1
    1. Lewis M, Bromley K, Sutton CJ, et al. . Determining sample size for progression criteria for pragmatic pilot RCTs: the hypothesis test strikes back! Pilot Feasibility Stud 2021;7:40. 10.1186/s40814-021-00770-x
    1. Kieser M, Wassmer G. On the use of the upper confidence limit for the variance from a pilot sample for sample size determination. Biometrics 1996;38:941–9. 10.1002/bimj.4710380806
    1. Malterud K, Siersma VD, Guassora AD. Sample size in qualitative interview studies: guided by information power. Qual Health Res 2016;26:1753–60. 10.1177/1049732315617444
    1. Saunders B, Sim J, Kingstone T, et al. . Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant 2018;52:1893–907. 10.1007/s11135-017-0574-8
    1. Soundy A, Lee RT, Kingstone T, et al. . Experiences of healing therapy in patients with irritable bowel syndrome and inflammatory bowel disease. BMC Complement Altern Med 2015;15:106. 10.1186/s12906-015-0611-x
    1. Mendoza T, Mayne T, Rublee D, et al. . Reliability and validity of a modified brief pain inventory short form in patients with osteoarthritis. Eur J Pain 2006;10:353–61. 10.1016/j.ejpain.2005.06.002
    1. Galvez-Sánchez CM, de la Coba P, Duschek S, et al. . Reliability, factor structure and predictive validity of the widespread pain index and symptom severity scales of the 2010 American College of rheumatology criteria of fibromyalgia. J Clin Med 2020;9:2460. 10.3390/jcm9082460
    1. Takasaki H, Treleaven J. Construct validity and test-retest reliability of the fatigue severity scale in people with chronic neck pain. Arch Phys Med Rehabil 2013;94:1328–34. 10.1016/j.apmr.2012.12.013
    1. Duruoz MT, Ulutatar F, Ozturk EC, et al. . Assessment of the validity and reliability of the Jenkins sleep scale in ankylosing spondylitis. Int J Rheum Dis 2019;22:275–9. 10.1111/1756-185X.13447
    1. et alBaranidharan G, Williams A, Wilson S. 2019 outcome measures. 1st edn, faculty of pain medicine of the Royal College of Anaesthetists. Available: [Accessed 6 Aug 2021].
    1. Chang K-V, Hung C-H, Sun W-Z, et al. . Evaluating soreness symptoms of fibromyalgia: establishment and validation of the revised fibromyalgia impact questionnaire with integration of soreness assessment. J Formos Med Assoc 2020;119:1211–8. 10.1016/j.jfma.2019.10.018
    1. Jensen OK, Callesen J, Nielsen MG, et al. . Reproducibility of tender point examination in chronic low back pain patients as measured by intrarater and inter-rater reliability and agreement: a validation study. BMJ Open 2013;3:e002532. 10.1136/bmjopen-2012-002532
    1. Bell T, Trost Z, Buelow MT, et al. . Meta-analysis of cognitive performance in fibromyalgia. J Clin Exp Neuropsychol 2018;40:698–714. 10.1080/13803395.2017.1422699
    1. Din NC, Meng ECT. Computerized Stroop tests: a review. J Psychol Psychother 2019;9:1.
    1. Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol 2012;65:301–8. 10.1016/j.jclinepi.2011.07.011
    1. Office for National Statistics . Review of the dissemination of health statistics: confidentiality guidance 2006 [online]. Available: [Accessed 2 Jul 2021].
    1. Data Protection Act . Data protection act 2018 [online], 2018. Available: [Accessed 15 Jul 2021].
    1. Braun V, Clarke V. Reflecting on reflexive thematic analysis. Qual Res Sport Exerc Health 2019;11:589–97. 10.1080/2159676X.2019.1628806
    1. Jakobsen JC, Gluud C, Wetterslev J, et al. . When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts. BMC Med Res Methodol 2017;17. 10.1186/s12874-017-0442-1
    1. UK Standards for Public Involvement . Better public involvement for better health and social care research, 2019. Available: [Accessed 5 Mar 2020].
    1. Staniszewska S, Brett J, Simera I, et al. . GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research. BMJ 2017;358:j3453. 10.1136/bmj.j3453
    1. Health Research Authority . Publication and dissemination of research findings [online], 2021. Available: [Accessed 2nd Aug 2021].
    1. Ross-Hellauer T, Tennant JP, Banelytė V, et al. . Ten simple rules for innovative dissemination of research. PLoS Comput Biol 2020;16:e1007704. 10.1371/journal.pcbi.1007704
    1. Wolfe F, Smythe HA, Yunus MB. The American College of rheumatology 1990 criteria for the classification of fibromyalgia. Report of the multicenter criteria Committee. Arthritis Rheum 1990;33:160–72. 10.1002/art.1780330203
    1. Tastekin N, Uzunca K, Sut N, et al. . Discriminative value of tender points in fibromyalgia syndrome. Pain Med 2010;11:466–71. 10.1111/j.1526-4637.2009.00784.x

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