About this trial
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
This trial does not accept healthy volunteersQualifiers
Axial pain of any origin
Polyathralgia of any origin
Myofascial pain of any origin
A diagnosis of chronic widespread pain or FM
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
Whole-Body Photobiomodulation Therapy
Device* 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 practice with the NovoTHOR device. * The LED equipment delivers red and near infrared light therapy to the participant * Session 1 = 6 minutes * Session 2 = 12 minutes * Sessions 3-18 = 20 minutes * Timescale: 3 treatments/week for 6 weeks * The dosage of LED light (also known as 'fluence') will be equivalent to 25J/cm2. The device will supply a dual wavelength of red and near-infrared light with a 50:50 ratio; 660nm and 850nm respectively
Treatment groups
Trial outcomes
Primary outcomes
To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates
Expressed at percentages/proportions
To investigate acceptability of the trial device and treatment schedule - by assessing refusal rates, dropout rates, trial retention rates
Expressed as percentages/proportions
To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions
Participant-reported experience questionnaire (qualitative)
To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions
Audio-recorded semi-structured interviews
Sponsors and contacts
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