Clinical trial NCT05069363: Whole-Body Photobiomodulation and Chronic Pain Trial
Official title: Whole-Body Photobiomodulation Therapy for Chronic Pain: a Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Sandwell & West Birmingham Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A feasibility study designed as a single centre and single-armed trial with embedded qualitative component
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

Patients eligible for the trial must comply with all of the following:

1. Currently diagnosed or receiving treatment for a widespread chronic pain condition, including but not limited to:

   1. Axial pain of any origin
   2. Polyathralgia of any origin
   3. Myofascial pain of any origin
   4. A diagnosis of chronic widespread pain or FM
2. Able to provide informed written consent
3. ≥18 years
4. Able to commit time to the trial treatment schedule of 6 weeks
5. Score as low or moderate risk on the COVID-19 risk stratification tool - applicable for the duration of the pandemic

Exclusion Criteria:

1. Pregnancy
2. Severe skin diseases (e.g. skin cancer, severe eczema, dermatitis, or psoriasis)
3. Body weight ≥136kg, as per manufacturer instructions \[see Appendix 3\]
4. Uncontrolled co-morbidities (e.g. uncontrolled diabetes defined as HbA1c \>69mmol/mol, decompensated heart failure, major psychiatric disturbance such as acute psychosis or suicidal ideation)
5. Use of systemic corticosteroid therapy including oral prednisolone or corticosteroid injections within the preceding 6 months as recommended by the manufacturer; steroids are thought to inhibit the anti-inflammatory effect of photobiomodulation therapy
6. Known active malignancy
7. Inability to enter the NovoTHOR device or lie flat for 20 minutes (either due to physical reasons or other e.g. claustrophobia)
8. Patients speaking a language for which an interpreter cannot be sought

Primary outcomes:
measure: To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates
timeFrame: 6 months
measure: To investigate acceptability of the trial device and treatment schedule - by assessing refusal rates, dropout rates, trial retention rates
timeFrame: 6 months
measure: To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions
timeFrame: 6 months
measure: To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions
timeFrame: 6 months
measure: To assess acceptability of outcome measures
timeFrame: 6 months
measure: Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
timeFrame: 6 months
measure: Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
timeFrame: 6 months
measure: Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
timeFrame: 6 months
measure: Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
timeFrame: 6 months
measure: Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
timeFrame: 6 months
measure: Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
timeFrame: 6 months
measure: Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
timeFrame: 6 months
measure: Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
timeFrame: 6 months
measure: Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
timeFrame: 6 months
measure: To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial
timeFrame: 6 months
measure: To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham NHS Trust
Study officials:
References:
citation: 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.