Chronic PainNCT05069363
Whole-Body Photobiomodulation and Chronic Pain Trial
A study testing Whole-Body Photobiomodulation Therapy in people with Chronic Pain, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Whole-Body Photobiomodulation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jan 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Sandwell and West Birmingham NHS Trust
Birmingham
Beth Fitzmaurice, 0121 507 4343, bfitzmaurice@nhs.net
0121 507 4344, swbh.painresearch@nhs.net
About this study
Official title: 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.
Read more
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
- Being tested
- Whole-Body Photobiomodulation Therapy
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Body Photobiomodulation TherapyDevice
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | All participants in this feasibility trial will receive a course of whole-body photobiomodulation therapy (18 sessions over 6 weeks) Receives: Device: Whole-Body Photobiomodulation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates
Expressed at percentages/proportions
Measured: 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
Measured: 6 months
To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions
Participant-reported experience questionnaire (qualitative)
Measured: 6 months
To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions
Audio-recorded semi-structured interviews
Measured: 6 months
To assess acceptability of outcome measures
Participant-reported experience questionnaire
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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)
Measured: 6 months
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
Patient global: Patient Global Impression of Change
1-7
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 6 months
To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial
Participant-reported experience questionnaire (qualitative)
Measured: 6 months
To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial
Audio-recorded semi-structured interviews
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start12 Jan 2022
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A feasibility study designed as a single centre and single-armed trial with embedded qualitative component
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Bethany Fitzmaurice, Sandwell & West Birmingham Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069363
- Sponsor's protocol ID
- 20PAIN01
- Status last verified
- Jun 2022
- First submitted
- 2 Sep 2021
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 35768101
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Body Photobiomodulation Therapy for Chronic Pain: a Feasibility Trial
- ClinicalTrials.gov ID
- NCT05069363
- Acronym / sponsor ID
- 20PAIN01
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sandwell & West Birmingham Hospitals NHS TrustUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A feasibility study designed as a single centre and single-armed trial with embedded qualitative component
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Whole-Body Photobiomodulation TherapyAll participants in this feasibility trial will receive a course of whole-body photobiomodulation therapy (18 sessions over 6 weeks) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Currently diagnosed or receiving treatment for a widespread chronic pain condition, including but not limited to:
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Intervention Group |
Primary outcome
To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates
Time frame: 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
Time frame: 6 months
Expressed as percentages/proportions
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)
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
To assess acceptability of outcome measures
Time frame: 6 months
Participant-reported experience questionnaire
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)
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.
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
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)
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
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)
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.
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
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
To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial
Time frame: 6 months
Participant-reported experience questionnaire (qualitative)
To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial
Time frame: 6 months
Audio-recorded semi-structured interviews
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Derived from this study: PubMed 35768101Fitzmaurice 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-Body Photobiomodulation Therapy in people with Chronic Pain, run by Sandwell & West Birmingham Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates (time frame: 6 months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05069363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.