Short- and Long-term Effects of Photobiomodulation on Pain, Functionality, Tissue Quality, Central Sensitisation and Psychological Factors in a Population Suffering From Fibromyalgia: Protocol for a Triple-blinded Randomized Clinical Trial.

Abstract

Background: The development of an integral and global treatment to improve the quality of life in those with fibromyalgia syndrome (FMS) is challenging.Methods: This study is a randomized, placebo-controlled clinical trial. Participants will be recruited in a private care practice and randomized to receive either a whole body Photobiomodulation (PBM) therapy program or placebo. Primary out comes will be pain (NumericPain Rating Scale; Widespread Pain Index; Symptom Severity Score), functionality (Fibromyalgia Impact Questionnaire; The Leisure Time Physical Activity Instrument), quality of soft tissue (elastography) and central sensitisation (pain pressure threshold and the Autonomic Symptom Profile). Secondary outcomes will be psychological factors (Pain Catastrophising scale, Tampa Scale, Self-Efficay questionnaire). Assessments will be at baseline (T1), after session 6 (T2), after treatment (T3) and 2 weeks (T4), 3 (T5) and 6 (T6) month´ follow-up.Discussion: PBM therapy has been shown to reduce pain and inflammation and to increase the rate of tissue repair for a wide range of conditions, but its potential use as a whole body treatment in FM is yet to be explored. This trial will investigate whether whole body PBM therapy is effective at reducing pain intensity, improving functionality, quality of soft tissue, central sensitisation symptoms and psychological measurements. Furthermore, 3 and 6 months follow up will investigate long-term efficacy of this treatment.Trial registration: NCT04248972. Registered on January 29, 2020, https://clinicaltrials.gov/ct2/show/NCT04248972?term=navarro-ledesma+santiago&draw=2&rank=2.

Short-Term Effects of Whole-Body Photobiomodulation on Pain, Quality of Life and Psychological Factors in a Population Suffering from Fibromyalgia: A Triple-Blinded Randomised Clinical Trial

“…The scoring scale is from 1 to 5 with the final scores ranging from 0 to 52. Higher scores correspond to higher levels of catastrophism [28].…”

“…It was first developed in 1995 and has three different aspects. The first part, called ''helplessness,'' corresponds to questions 1-5 and 12 and refers to what the person believes they have been able to do to influence their pain [28].…”

“…Lastly, ''rumination'' corresponds to questions 8-11 and refers to the fact that the patient is unable to stop thinking about the pain and cannot get away from the idea [28].…”

“…Hence, the total score will vary between a minimum of 11 and a maximum of 44. A high score translates as a greater fear of movement/injury, that is, high levels of kinesiophobia [28,30]. The Tampa Scale for Kinesiophobia-11 has been shown to be consistent, reliable and appropriate to assess fear of movement in patients with FM within a clinical context [31].…”

“…To our knowledge, this is the first study to use whole-body PBM in FM patients. The protocol study of the present research has been previously published [20].…”