Whole-Body Photobiomodulation and Chronic Pain Trial

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Whole-Body Photobiomodulation Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Recruiting
    • Sandwell and West Birmingham NHS Trust
    • Contact: Beth Fitzmaurice; Phone Number: 0121 507 4343; Email: bfitzmaurice@nhs.net
    • Contact: Phone Number: 0121 507 4344; Email: swbh.painresearch@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Group; All participants in this feasibility trial will receive a course of whole-body photobiomodulation therapy (18 sessions over 6 weeks)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates	Expressed at percentages/proportions	6 months
To investigate acceptability of the trial device and treatment schedule - by assessing refusal rates, dropout rates, trial retention rates	Expressed as percentages/proportions	6 months
To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions	Participant-reported experience questionnaire (qualitative)	6 months
To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions	Audio-recorded semi-structured interviews	6 months
To assess acceptability of outcome measures	Participant-reported experience questionnaire	6 months
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy	Pain: Brief Pain Inventory-Short Form Pain severity - 4xNRS questions (0-40) Interference - 7xNRS questions (0-70)	6 months
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy	Pain: Widespread Pain Index/Symptom Severity Score WPI score 0-19, SSS 0-12. Total out of 31.	6 months
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy	Fatigue: Fatigue Severity Scale 9 x Likert scale questions (1-7). Final score=mean	6 months
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy	Sleep disturbance: Jenkins Sleep Questionnaire 4 x 0-5 questions (total score out of 20)	6 months
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy	Patient global: Patient Global Impression of Change 1-7	6 months
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy	Multidimensional function: Revised Fibromyalgia Impact Questionnaire (FIQR) 21 x NRS questions (0-100)	6 months
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy	Anxiety and Depression: Hospital Anxiety and Depression Score 7x Likert scale questions (0-3). Total out of 21.	6 months
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy	Tenderness: dolorimeter to apply a set pressure of <4kg/cm2 to 18 tender points NRS for pain at each point (0-10). MTPS/FIS score total 0 - 180	6 months
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy	Dyscognition: Stroop Test (to assess inhibitory control and processing speed) Number of correct answers in 60 seconds. No negative marking	6 months
To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial	Participant-reported experience questionnaire (qualitative)	6 months
To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial	Audio-recorded semi-structured interviews	6 months

Collaborators and Investigators

• Sponsor: Sandwell & West Birmingham Hospitals NHS Trust

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 2, 2021
• First Submitted That Met QC Criteria: September 25, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 26, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 20PAIN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes