Whole-Body Photobiomodulation Therapy for Chronic Pain: a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
结局指标
主要结局
To determine whether eligibility criteria is either too open/restrictive by estimating eligibility and recruitment rates
时间窗: 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
时间窗: 6 months
Expressed as percentages/proportions
To assess acceptability of outcome measures
时间窗: 6 months
Participant-reported experience questionnaire
To assess participants' perceptions of randomisation, blinding and placebo therapy in a future trial
时间窗: 6 months
Participant-reported experience questionnaire (qualitative)
To explore acceptability of the trial device and treatment schedule in terms of perceptions, values and opinions
时间窗: 6 months
Participant-reported experience questionnaire (qualitative)
Exploratory outcomes will aim to assess potential effectiveness of whole-body PBM therapy
时间窗: 6 months
Pain: Brief Pain Inventory-Short Form Pain severity - 4xNRS questions (0-40) Interference - 7xNRS questions (0-70)
次要结局
未报告次要终点
研究者
Dr Bethany Fitzmaurice
Clinical Fellow in Pain Medicine
Sandwell & West Birmingham Hospitals NHS Trust
