Effects of Photobiomodulation in a Population Suffering From Fibromyalgia

A study testing PBM in people with Fibromyalgia and Chronic Pain, run by University of Malaga at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Fibromyalgia, Chronic Pain
What is being tested?: PBM
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteSpain
Study dates: 30 Jan 2021to 30 Jan 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

University of Granada
Granada, 18016

Other trials in Spain

About this study

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.

Read the 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
Being tested: PBM, PLACEBO PBM
Medical subject headings: Fibromyalgia, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04248972
Study group	Role	What they receive
Intervention	Experimental	A treatment with whole body red light therapy (NovoTHOR®) will be carried out Receives: Device: PBM
PLACEBO INTERVENTION	Placebo comparator	A placebo whole body red light will be carried out Receives: Other: PLACEBO PBM

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Assessment of the mechanisms by which catastrophizing impacts on pain experience. Higher scores mean a better outcome and lower scores mean a worst outcome.
Measured: 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.
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 202130 Jan 2022

First posted30 Jan 2020
Study start30 Jan 2021
Primary completion30 Jul 2021
Study completion30 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04248972
Sponsor's protocol ID: PBMFM
Status last verified: Feb 2022
First submitted: 18 Jan 2020
Last updated: 28 Feb 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 35222905

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT04248972
Acronym / sponsor ID: PBMFM
Conditions: Fibromyalgia, Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: University of MalagaUniversity, hospital or other
Study start: 30 Jan 2021 (actual)
Primary completion: 30 Jul 2021 (actual)
Study completion: 30 Jan 2022 (actual)
First posted: 30 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Device: PBMA treatment with whole body red light therapy (NovoTHOR®) will be carried out
PLACEBO INTERVENTION	Placebo comparator	Other: PLACEBO PBMA placebo whole body red light will be carried out

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PBMA whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes	Device	Intervention
PLACEBO PBMA placebo whole body red light will be carried out during 20 minutes	Other	PLACEBO INTERVENTION

Primary outcome

Change from baseline perceived pain at 6 months
Time frame: 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)
Visual Analogue Scale (VAS) is used by the patient to quantify the pain from 0 (without any pain) to 10 (the worst pain)
Change from baseline Leisure Time Physical Activity Instrument (LTPAI) at 6 months
Time frame: 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)
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
Change from baseline Widespread Pain Index (WPI) at 6 months
Time frame: 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)
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.
Change from baseline Symptom Severity Score (SSS) at 6 months
Time frame: 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)
Symptom Severity Score (SSS) is a questionnaire whichispart of the FMS diagnosis
Change from baseline Impact Questionnaire (FIQR) at 6 months
Time frame: 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)
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.
Change from baseline Pain pressure threshold in neck and upper limb at 6 months
Time frame: 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)
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.
Change from baseline Pain pressure threshold in lower limb at 6 months
Time frame: 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)
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.
Change from autonomic nervous system activity at 6 months
Time frame: 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)
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.
Change from elastography at 6 months
Time frame: 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)
Quantified elastography in tender points. Changes in the status of myofascial trigger-points can be demonstrated with an objective and reproducible USE measure

3 secondary outcomes

Change from baseline Pain catastrophizing Scale (PCS) at 6 months
Time frame: 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 frame: 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 frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
Derived from this study: PubMed 35222905Navarro-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.

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PBM in people with Fibromyalgia and Chronic Pain, run by University of Malaga at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline perceived pain at 6 months (time frame: 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)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248972, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.