Effects of Photobiomodulation in a Population Suffering From Fibromyalgia

Study Overview
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Brief Summary
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The development of an integral and global treatment to improve the quality of life in those with fibromyalgia syndrome (FMS) is challenging, thus a whole body Photobiomodulation (PBM) therapy program is proposed as an effective option.

Detailed Description
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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 outcomes will be pain (Numeric Pain 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-Efficacy questionnaire). Assessments will be at baseline, after treatment 6, immediately following the last treatment (4 weeks), and then 2 weeks and at 3 monthly follow up intervals to 6 months after completion of treatment.

Official Title
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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.

Conditions
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Fibromyalgia, Chronic Pain

Intervention / Treatment
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* Device: PBM
* Other: PLACEBO PBM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed from FM presenting generalized pain in at least four or five regions. Present symptoms for at least 3 months at similar levels. Exclusion Criteria: - Inflammatory, neurological, or orthopedic disease which can alter balance, hearing, and vision, and cognitive impairment in terms of the ability to answer questions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>A treatment with whole body red light therapy (NovoTHOR®) will be carried out | Device: PBM<br>* A whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes<br>|
| Placebo Comparator: PLACEBO INTERVENTION<br>A placebo whole body red light will be carried out | Other: PLACEBO PBM<br>* A placebo whole body red light will be carried out during 20 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline perceived pain at 6 months | Visual Analogue Scale (VAS) is used by the patient to quantify the pain from 0 (without any pain) to 10 (the worst pain) | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 
| Change from baseline Leisure Time Physical Activity Instrument (LTPAI) at 6 months | The Leisure Time Physical Activity Instrument (LTPAI), used to measure the physical activity. This has four components, each with three levels of activity: light, medium, and vigorous. Scores indicate the number of hours which these activity levels had been carried out each week in the last four weeks summing as the total number of hours of physical activity | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 
| Change from baseline Widespread Pain Index (WPI) at 6 months | Widespread Pain Index (WPI) is a questionnaire which shows appropriate distribution and a sufficient number of body quadrants and axial skeleton pain representation. It is part of the FMS diagnosis. | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 
| Change from baseline Symptom Severity Score (SSS) at 6 months | Symptom Severity Score (SSS) is a questionnaire whichispart of the FMS diagnosis | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 
| Change from baseline Impact Questionnaire (FIQR) at 6 months | The revised Fibromyalgia Impact Questionnaire (FIQR), a self-administered questionnaire comprising 21 individual questions, with a rating scale of 0-10. The questions compose three different domains: function, overall impact and symptoms score (range 0-30, 0-20 and 0-50, respectively). The FIQR total score ranges from 0 to 100, with a higher score indicating a greater impact of the condition on the person'slife. | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 
| Change from baseline Pain pressure threshold in neck and upper limb at 6 months | Tender points will be assessed using a standard pressure algometer (FPK 20; Wagner Instruments, Greenwich, CT, USA.): occiput at the suboccipital muscle insertions, low cervical at the anterior aspects of the intertransverse spaces at C5-C7, trapezius at the midpoint of the upper border, supraspinatus at origins, above the scapula spine near the medial border, paraspinous 3 cm lateral to the midline at the level of the mid-scapula, second rib at the second costochondral junctions, just lateral to the junctions on the upper surfaces, lateral pectoral at the level of the fourth rib at the anterior axillary line, lateral epicondylee 2 cm distal to the epicondyles and medial epicondyle at the epicondyles. | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 
| Change from baseline Pain pressure threshold in lower limb at 6 months | Tender points will be assessed using a standard pressure algometer (FPK 20; Wagner Instruments, Greenwich, CT, USA.): gluteal at the upper outer quadrants of buttocks in anterior fold of muscle, greater trochanter just posterior to the trochanteric prominence, and knees at the medial fat pad proximal to the joint line, forearm at the distal dorsal third of the forearm, thumbnail, and midfoot at the midpoint of the dorsal third metatarsal. | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 
| Change from autonomic nervous system activity at 6 months | The Autonomic Symptom Profile (ASP) is a validated self-report questionnaire that comprehensively assesses autonomic symptoms across 11 subscales and yields a composite autonomic symptom score, where higher scores mean a better outcome and lower scores mean a worst outcome. Autonomic nervous system activity provides quantitative information regarding cardiac autonomic tone. | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 
| Change from elastography at 6 months | Quantified elastography in tender points. Changes in the status of myofascial trigger-points can be demonstrated with an objective and reproducible USE measure | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Pain catastrophizing Scale (PCS) at 6 months | Assessment of the mechanisms by which catastrophizing impacts on pain experience. Higher scores mean a better outcome and lower scores mean a worst outcome. | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 
| Change from baseline kinesiophobia at 6 months | Assessment of the fear of movement through the validated Tampa-Scale questionnaire. Higher scores mean a better outcome and lower scores mean a worst outcome. | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) | 
| Change from baseline self efficacy questionnaire at 6 month | The Self Efficacy Questionnaire assesses personal confidence to carry out an activity with the aim of successfully achieving a desired outcome. Higher scores mean a better outcome and lower scores mean a worst outcome. | time (t) 1(prior to treatment), t2 (immediately after treatment 6), t3 (3 immediately following the last treatment), t4 (2 weeks after completion of treatment), t5 ( 3 months after completion of treatment), t6 ( 6 months after completion of treatment) |