NCT04248972

Effects of Photobiomodulation in a Population Suffering From Fibromyalgia

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: University of Malaga · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia
• Chronic Pain

Interventions

Type	Name	Description
DEVICE	PBM	A whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes
OTHER	PLACEBO PBM	A placebo whole body red light will be carried out during 20 minutes

Timeline

• Start date: 2021-01-30
• Primary completion: 2021-07-30
• Completion: 2022-01-30
• First posted: 2020-01-30
• Last updated: 2022-02-28

Locations

1 site across 1 country: Spain