At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Whole-Body Photobiomodulation Therapy (device)
- How long the study runs
- Study runs about 20 months (dates as stated)
- About the drug or intervention
- 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 100 Years
- Who
- All
- Number of participants
- 20
- Started
- 2022-01-12
- Last checked
- 2022-06
Plain English Summary
What is this study?
- • Testing a new treatment for chronic pain
- • NA - 20 participants
- • Chronic pain is a common long-term condition that can affect any area throughout the body
Who can take part?
- • Ages 18 Years to 100 Years
- • Diagnosed with chronic pain
Where?
- • Birmingham - Sandwell and West Birmingham NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This 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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 100 Years
- Who can join: All genders
What the study is looking for
- ✓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
Who cannot take part
- ✗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,...
- ✗Known active cancer
See the full criteria
Where Is This Study? (1 UK site)
Sandwell and West Birmingham NHS Trust
Birmingham, United Kingdom