Clinical trial NCT04248972: Effects of Photobiomodulation in a Population Suffering From Fibromyalgia
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline perceived pain at 6 months
timeFrame: 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)
measure: Change from baseline Leisure Time Physical Activity Instrument (LTPAI) at 6 months
timeFrame: 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)
measure: Change from baseline Widespread Pain Index (WPI) at 6 months
timeFrame: 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)
measure: Change from baseline Symptom Severity Score (SSS) at 6 months
timeFrame: 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)
measure: Change from baseline Impact Questionnaire (FIQR) at 6 months
timeFrame: 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)
measure: Change from baseline Pain pressure threshold in neck and upper limb at 6 months
timeFrame: 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)
measure: Change from baseline Pain pressure threshold in lower limb at 6 months
timeFrame: 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)
measure: Change from autonomic nervous system activity at 6 months
timeFrame: 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)
measure: Change from elastography at 6 months
timeFrame: 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:
measure: Change from baseline Pain catastrophizing Scale (PCS) at 6 months
timeFrame: 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)
measure: Change from baseline kinesiophobia at 6 months
timeFrame: 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)
measure: Change from baseline self efficacy questionnaire at 6 month
timeFrame: 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)
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
References:
citation: 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.