Whole-Body Photobiomodulation and Chronic Pain Trial
Recruiting now · Not applicable
Conditions studied: Chronic Pain
In brief
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.
Key facts
- Study ID
- NCT05069363
- Run by
- Sandwell & West Birmingham Hospitals NHS Trust
- People needed
- 20
- Starts
- 2022-01-12
- Expected to finish
- 2023-09-01
- Last updated by the study team
- 2022-06-30
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sandwell and West Birmingham NHS Trust — Birmingham, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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