Effects of Photobiomodulation in a Population Suffering From Fibromyalgia

NCT04248972 | Completed

• 1 other identifier: PBMFM
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia; Chronic Pain

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (3)

• Change from baseline Pain catastrophizing Scale (PCS) at 6 months

  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

  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

  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)

Study Arms (2)

Intervention

EXPERIMENTAL

A treatment with whole body red light therapy (NovoTHOR®) will be carried out

Device: PBM

PLACEBO INTERVENTION

PLACEBO COMPARATOR

A placebo whole body red light will be carried out

Other: PLACEBO PBM

Interventions

PBM DEVICE

A whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes

Intervention

PLACEBO PBM OTHER

A placebo whole body red light will be carried out during 20 minutes

PLACEBO INTERVENTION

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed from FM presenting generalized pain in at least four or five regions.
• Present symptoms for at least 3 months at similar levels.

You may not qualify if:

• \- Inflammatory, neurological, or orthopedic disease which can alter balance, hearing, and vision, and cognitive impairment in terms of the ability to answer questions.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

University of Granada

Granada, 18016, Spain

Location

Related Publications (1)

• Navarro-Ledesma S, Gonzalez-Munoz A, Carroll J, Burton P. Short- and long-term effects of whole-body photobiomodulation on pain, functionality, tissue quality, central sensitisation and psychological factors in a population suffering from fibromyalgia: protocol for a triple-blinded randomised clinical trial. Ther Adv Chronic Dis. 2022 Feb 21;13:20406223221078095. doi: 10.1177/20406223221078095. eCollection 2022.

  PMID: 35222905 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UNIVERSITY PROFESSOR

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 30, 2020
• Study Start: January 30, 2021
• Primary Completion: July 30, 2021
• Study Completion: January 30, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

ES (1)