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RECRUITING
NCT05069363
NA

Whole-Body Photobiomodulation and Chronic Pain Trial

Sponsor: Sandwell & West Birmingham Hospitals NHS Trust

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-01-12

Completion Date

2023-09

Last Updated

2022-06-30

Healthy Volunteers

No

Conditions

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 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

Locations (1)

Sandwell and West Birmingham NHS Trust

Birmingham, United Kingdom