Whole-Body Photobiomodulation and Chronic Pain Trial

NCT05069363 | Recruiting DMC FDA Device

• 1 other identifier: 20PAIN01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (16)

• 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

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sandwell & West Birmingham Hospitals NHS Trust: lead

Study Sites (1)

Sandwell and West Birmingham NHS Trust

Birmingham, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 35768101 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow in Pain Medicine

Model Details: A feasibility study designed as a single centre and single-armed trial with embedded qualitative component

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: October 6, 2021
• Study Start: January 12, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)