Whole-Body Photobiomodulation and Chronic Pain Trial

NCT ID: NCT05069363

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2023-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

Whole-Body Photobiomodulation Therapy

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandwell & West Birmingham Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Dr Bethany Fitzmaurice

Clinical Fellow in Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sandwell and West Birmingham NHS Trust

Birmingham, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Facility Contacts

Beth Fitzmaurice

Role: primary

bfitzmaurice@nhs.net

0121 507 4343

Role: backup

swbh.painresearch@nhs.net

0121 507 4344

References

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.

Reference Type: DERIVED

PMID: 35768101 (View on PubMed)

Other Identifiers

20PAIN01

Identifier Type: -

Identifier Source: org_study_id