Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders and Spasticity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
The clinical study is titled the CRYONIC PROTOCOL, which stands for Cryotherapy for Neurolysis In Chronic Pain and spasticity. It is structured as a prospective, multi-cohort observational study.
Purpose of the Study:
The overarching purpose of the CRYONIC PROTOCOL study is to assess the Correlation Between Diagnostic Nerve Block Response and Cryoneurolysis Outcome in Chronic Musculoskeletal Disorders and Spasticity. The study focuses on evaluating the effectiveness of ultrasound-guided peripheral nerve cryoneurolysis, a minimally invasive technique that uses extreme cold to induce temporary nerve blocks, for patients with treatment-resistant chronic musculoskeletal pain and spasticity.
The study also seeks to determine if cryoneurolysis itself leads to meaningful improvements in both pain intensity and functional ability in the included patient cohorts (those with chronic musculoskeletal pain or spasticity)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be over 18 year old
- •Adults (> 18y) with either chronic musculoskeletal pain (> 3 months; average NRS > 5/10) or painful/functionally limiting spasticity
- •Have a clinical stable condition, > 3months
- •Any medications must be maintained on a stable schedule- Able to understand study instructions and provide informed consent (ICF) in French or Dutch.Provide written informed consent
排除标准
- •Contraindication to cryoneurolysis such as a diagnosis of cryoglobulinemia, paroxysmal cold haemoglobinuria, cold urticaria, Raynaud's disease, any form of peripheral neuropathy, open and or infected wounds of the affected limb
- •Patient's refusal to give consent to the procedure or to use of their data for research purposes.
- •Ongoing local or systemic infection before the procedure.
- •Predominantly neuropathic pain of the upper extremity as assessed with the Pain Detect questionnaire
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: 3 months
Correlation between diagnostic nerve bloc and cryoneurolysis
次要结局
- Modified Tardieu Scale(3 months)
- 2-Minute Walk Test (2MWT)(3 months)
- Timed Up and Go(3 months)
- Passive Range of Motion(3 months)
- Goal Attainment Scaling(3 months)
- Modified Ashworth Scale(3 months)
- Oswestry Disability Index (Low Back Pain)(3 months)
- Shoulder Pain and Disability Index (Shoulder)(3 months)
- Disabilities of the Arm, Shoulder, and Hand (Arm/Shoulder)(3 months)
- Hip Disability and Osteoarthritis Outcome Score (Hip)(3 months)
- Knee Injury and Osteoarthritis Outcome Score (Knee)(3 months)
- Work Ability Index(3 months)
- Medication Quantification Scale (Version III)(3 months)
- Pain Self-Efficacy Questionnaire(3 months)
- Tampa Scale for Kinesiophobia (11 items)(3 months)
- EuroQol 5 Dimensions, 5 Levels(3 months)
- Patient-Reported Outcomes Measurement Information System - 29 items(3 months)
- Brief Pain Inventory(3 months)