Effects of Photobiomodulation in a Population Suffering From Fibromyalgia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-30

Study Completion Date

2022-01-30

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.

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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.

Conditions

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Fibromyalgia Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

PBM

Intervention Type DEVICE

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

PLACEBO INTERVENTION

A placebo whole body red light will be carried out

Group Type PLACEBO_COMPARATOR

PLACEBO PBM

Intervention Type OTHER

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

Interventions

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PBM

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

Intervention Type DEVICE

PLACEBO PBM

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

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No