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临床试验/NCT05069363
NCT05069363招募中不适用

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

Sandwell & West Birmingham Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月12日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Bethany Fitzmaurice

Clinical Fellow in Pain Medicine

Sandwell & West Birmingham Hospitals NHS Trust

研究点 (1)

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