Cryoneurolysis Outcome on Pain Experience (COPE) in Patients With Low-back Pain - a Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The effect of the intervention, assessed by Patient Global Impression of Change (PGIC) at 4 weeks follow-up
研究概览
简要总结
This study will provide information on the effectiveness of cryoneurolysis for patients with facet joint pain syndrome, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population.
详细描述
Background: Low-back pain, including facet joint pain, accounts for up to 20 percent of all sick leaves in Denmark; among these are patients with facet joint pain syndrome. A proposed treatment option is cryoneurolysis. This study aims to investigate the effect of cryoneurolysis in lumbar facet joint pain syndrome
Methods: A single-center randomized controlled trial (RCT) is performed including 120 participants with chronic facet joint pain syndrome, referred to the Department of Neurosurgery, Aarhus University Hospital. Eligible patients receive a diagnostic anesthetic block, where a reduction of pain intensity >50 % on a numerical rating scale (NRS) is required to be enrolled. Participants are randomized into three groups to undergo either one treatment of cryoneurolysis, radiofrequency ablation or placebo. Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments. All groups receive physiotherapy for 6 weeks, starting 4 weeks after treatment. The primary outcome is a reduction in low-back pain intensity and an impression of change in pain after intervention (Patient Global Impression of Change (PGIC)) at 4 weeks follow-up, prior to physiotherapy. Secondary outcomes are quality of life (EQ-5D, SF-36) and level of function (Oswestry Disability Index), psychological perception of pain (Pain Catastrophizing Scale) and depression status (Major Depression Inventory). Data will be assessed at baseline (T0), randomization (T1), day one (T2), 4 weeks (T3), 3 (T4), 6 (T5) and 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Outcomes Assessors, physiotherapists and participants are blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Low-back pain from facet joint syndrom (facet joint pain) > 3 months' duration with or without neuropathic pain component.
- •Low-back pain on Numeric Rating Scale ≥ 4
排除标准
- •Presence of nerve root or spinal canal compression; signs of inflammatory or erosive processes in the spine verified on magnetic resonance imaging (MRI).
- •Neurological deficits i.e. symptoms of nerve root compression; tingling, numbness, weakness/ paresis, and reflex loss in the lower extremities.
- •Major co-morbidity.
- •Anti-thrombotic or anti-platelet treatment which cannot be paused for a week.
- •Active malignancies.
- •Chronic inflammatory disease.
- •Known severe psychiatric disease. Patients with mild and well-treated depression and anxiety are not excluded.
结局指标
主要结局
The effect of the intervention, assessed by Patient Global Impression of Change (PGIC) at 4 weeks follow-up
时间窗: 4 weeks
The Patient Global Impression of Change (PGIC) is a 7-point patient self-reporting scale of overall improvement after treatment ranging from 1) very much improved, 2) much improved, 3) minimally improved, 4) no change, 5) minimally worse, 6) much worse, or 7) very much worse
次要结局
- Change in the Numeric Rating Scale (NRS-11) from baseline to day one, four weeks, three, six and 12 months follow-up(1-12 months)
- Change from baseline to 12 months follow-up for change in Major Depression Inventory (MDI) and the Short Form (36) Health Survey (SF-36)(1-12 months)
- Change in Patient Global Impression of Change (PGIC) at day one, three, six and 12 months follow-up.(1-12 months)
- Change in the Pain Catastrophizing Scale (PCS) at baseline, four weeks, three, six and 12 months follow-up(1-12 months)
- Change from baseline to six and 12 months follow-up in the Oswestry Disability Index (ODI).(1-12 months)
- Change from baseline to six and 12 months follow-up in the European Quality of Life - 5 Dimensions (EQ5D)(1-12 months)