Whole-Body Photobiomodulation and Chronic Pain Trial

Not Applicable

Recruiting

• Conditions: Chronic Pain
• Interventions: Device: Whole-Body Photobiomodulation Therapy

• Registration Number: NCT05069363
• Lead Sponsor: Sandwell & West Birmingham Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-25
• Study First Posted: 2021-10-06
• Study Start: 2022-01-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-26
• Last Update Posted: 2022-06-30
• Primary Completion: 2022-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Whole-Body Photobiomodulation Therapy	All participants in this feasibility trial will receive a course of whole-body photobiomodulation therapy (18 sessions over 6 weeks)

Primary Outcome Measures

Name	Time	Method
To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates	6 months	Expressed at percentages/proportions
To investigate acceptability of the trial device and treatment schedule - by assessing refusal rates, dropout rates, trial retention rates	6 months	Expressed as percentages/proportions
To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions	6 months	Audio-recorded semi-structured interviews
To assess acceptability of outcome measures	6 months	Participant-reported experience questionnaire
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy	6 months	Dyscognition: Stroop Test (to assess inhibitory control and processing speed); Number of correct answers in 60 seconds. No negative marking
To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial	6 months	Audio-recorded semi-structured interviews

Trial Locations

Locations (1)

Sandwell and West Birmingham NHS Trust; 🇬🇧 Birmingham, United Kingdom