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Chronic pain is a common long-term condition that can affect any area throughout the body. Individuals suffering with chronic pain often have associated fatigue, sleep and mood disturbances.
Current treatments for chronic pain include a variety of both medicine-based approaches and non-medical approaches such as exercise and psychology treatments. Patients often take a combination of medications such as antidepressants and strong medications like morphine - which are not always effective, and often associated with several troublesome side effects. Despite physical activity being a common and helpful treatment, evidence shows that patients with chronic pain can find it difficult to engage for a variety of reasons. It would be helpful to see if other non-medication based approaches will be an acceptable treatment to those suffering with chronic pain.
Photobiomodulation (PBM) therapy describes a safe, non-invasive low-energy light therapy that has been successful in treating a variety of chronic pain conditions. Cells absorb light to produce a series of reactions that culminate in pain relief, reduced inflammation, and tissue repair. Most studies examining effects of PBM have consisted of a small hand-held probe focused on specific painful areas. There are a cohort of chronic pain conditions that encompass widespread throughout the back, neck and joints, such as fibromyalgia (FM). Whole-body PBM therapy is able to treat a large area of the body in a short space of time.
The main purpose of the study is to determine feasibility, with a view to guiding a definitive Randomised Controlled Trial (RCT), in terms of: feasibility of eligibility criteria, recruitment rates, acceptability of trial device in the chronic pain population, and acceptability of outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | All participants in this feasibility trial will receive a course of whole-body photobiomodulation therapy (18 sessions over 6 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-Body Photobiomodulation Therapy | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates | Expressed at percentages/proportions | 6 months |
| To investigate acceptability of the trial device and treatment schedule - by assessing refusal rates, dropout rates, trial retention rates | Expressed as percentages/proportions | 6 months |
| To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions | Participant-reported experience questionnaire (qualitative) | 6 months |
| To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions | Audio-recorded semi-structured interviews | 6 months |
| To assess acceptability of outcome measures | Participant-reported experience questionnaire | 6 months |
| Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | Pain: Brief Pain Inventory-Short Form Pain severity - 4xNRS questions (0-40) Interference - 7xNRS questions (0-70) | 6 months |
| Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | Pain: Widespread Pain Index/Symptom Severity Score WPI score 0-19, SSS 0-12. Total out of 31. |
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Inclusion Criteria:
Patients eligible for the trial must comply with all of the following:
Currently diagnosed or receiving treatment for a widespread chronic pain condition, including but not limited to:
Able to provide informed written consent
≥18 years
Able to commit time to the trial treatment schedule of 6 weeks
Score as low or moderate risk on the COVID-19 risk stratification tool - applicable for the duration of the pandemic
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandwell and West Birmingham NHS Trust | Recruiting | Birmingham | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35768101 | Derived | Fitzmaurice B, Heneghan NR, Rayen A, Soundy A. Whole-body photobiomodulation therapy for chronic pain: a protocol for a feasibility trial. BMJ Open. 2022 Jun 29;12(6):e060058. doi: 10.1136/bmjopen-2021-060058. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 10, 2023 | Apr 5, 2023 | 2 | ||
| Apr 6, 2023 |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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A feasibility study designed as a single centre and single-armed trial with embedded qualitative component
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|
| 6 months |
| Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | Fatigue: Fatigue Severity Scale 9 x Likert scale questions (1-7). Final score=mean | 6 months |
| Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | Sleep disturbance: Jenkins Sleep Questionnaire 4 x 0-5 questions (total score out of 20) | 6 months |
| Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | Patient global: Patient Global Impression of Change 1-7 | 6 months |
| Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | Multidimensional function: Revised Fibromyalgia Impact Questionnaire (FIQR) 21 x NRS questions (0-100) | 6 months |
| Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | Anxiety and Depression: Hospital Anxiety and Depression Score 7x Likert scale questions (0-3). Total out of 21. | 6 months |
| Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | Tenderness: dolorimeter to apply a set pressure of <4kg/cm2 to 18 tender points NRS for pain at each point (0-10). MTPS/FIS score total 0 - 180 | 6 months |
| Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy | Dyscognition: Stroop Test (to assess inhibitory control and processing speed) Number of correct answers in 60 seconds. No negative marking | 6 months |
| To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial | Participant-reported experience questionnaire (qualitative) | 6 months |
| To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial | Audio-recorded semi-structured interviews | 6 months |
| May 4, 2023 |
| 3 |
| Aug 28, 2025 | Sep 17, 2025 | 4 |