Whole-Body Photobiomodulation and Chronic Pain Trial

Official title

Whole-Body Photobiomodulation Therapy for Chronic Pain: a Feasibility Trial

Overview

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.

Interventions

• Device Whole-Body Photobiomodulation Therapy
  * All participants entering the trial will receive a course of whole-body PBM therapy * The NovoTHOR Whole-Body PBM therapy device consists of a hinged, clamshell design with light-emitting diodes (LEDs) arranged to emit near-infrared and visible red light therapy is delivered to the entire body at once. * Participants will be expected to lie horizontal in the device with the lid as closed as they are comfortable with. * 18 sessions is the currently recommended and widely instituted and accepted

Primary outcome measures

• To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates [Time frame: 6 months]
• To investigate acceptability of the trial device and treatment schedule - by assessing refusal rates, dropout rates, trial retention rates [Time frame: 6 months]
• To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions [Time frame: 6 months]
• To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions [Time frame: 6 months]
• To assess acceptability of outcome measures [Time frame: 6 months]
• Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy [Time frame: 6 months]
• Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy [Time frame: 6 months]
• Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy [Time frame: 6 months]
• Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy [Time frame: 6 months]
• Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy [Time frame: 6 months]

Eligibility criteria

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:

• Axial pain of any origin
• Polyathralgia of any origin
• Myofascial pain of any origin
• A diagnosis of chronic widespread pain or FM
• 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

• Pregnancy
• Severe skin diseases (e.g. skin cancer, severe eczema, dermatitis, or psoriasis)
• Body weight ≥136kg, as per manufacturer instructions \[see Appendix 3\]
• 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)
• 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
• Known active malignancy
• Inability to enter the NovoTHOR device or lie flat for 20 minutes (either due to physical reasons or other e.g. claustrophobia)
• Patients speaking a language for which an interpreter cannot be sought

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Sandwell and West Birmingham NHS Trust — Birmingham

Publications

• 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. PMID 35768101

Identifiers

NCT: NCT05069363 · 20PAIN01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗