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NCT Number: NCT05069363

Whole-Body Photobiomodulation and Chronic Pain 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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates

    Time frame: 6 months

    Expressed at percentages/proportions

  2. To investigate acceptability of the trial device and treatment schedule - by assessing refusal rates, dropout rates, trial retention rates

    Time frame: 6 months

    Expressed as percentages/proportions

  3. To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions

    Time frame: 6 months

    Participant-reported experience questionnaire (qualitative)

  4. To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions

    Time frame: 6 months

    Audio-recorded semi-structured interviews

  5. To assess acceptability of outcome measures

    Time frame: 6 months

    Participant-reported experience questionnaire

  6. Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy

    Time frame: 6 months

    Pain: Brief Pain Inventory-Short Form

    Pain severity - 4xNRS questions (0-40) Interference - 7xNRS questions (0-70)

  7. Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy

    Time frame: 6 months

    Pain: Widespread Pain Index/Symptom Severity Score

    WPI score 0-19, SSS 0-12. Total out of 31.

  8. Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy

    Time frame: 6 months

    Fatigue: Fatigue Severity Scale

    9 x Likert scale questions (1-7). Final score=mean

  9. Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy

    Time frame: 6 months

    Sleep disturbance: Jenkins Sleep Questionnaire

    4 x 0-5 questions (total score out of 20)

  10. Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy

    Time frame: 6 months

    Patient global: Patient Global Impression of Change

    1-7

  11. Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy

    Time frame: 6 months

    Multidimensional function: Revised Fibromyalgia Impact Questionnaire (FIQR)

    21 x NRS questions (0-100)

  12. Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy

    Time frame: 6 months

    Anxiety and Depression: Hospital Anxiety and Depression Score

    7x Likert scale questions (0-3). Total out of 21.

  13. Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy

    Time frame: 6 months

    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

  14. Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy

    Time frame: 6 months

    Dyscognition: Stroop Test (to assess inhibitory control and processing speed)

    Number of correct answers in 60 seconds. No negative marking

  15. To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial

    Time frame: 6 months

    Participant-reported experience questionnaire (qualitative)

  16. To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial

    Time frame: 6 months

    Audio-recorded semi-structured interviews

Sponsors and collaborators

Lead sponsor

Sandwell & West Birmingham Hospitals NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Oct 6, 2021
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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