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临床试验/NCT07321366
NCT07321366招募中不适用

Efficacy and Tolerability of Cryoneurolysis Treatment in Disabling and/or Painful Hypertonia of the Shoulder and Elbow in Patients With Cerebral Palsy Who Have Reached a Therapeutic Impasse a Pilot Study

Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月22日最近更新:
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干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Goal Assessment Scale
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main objective of this study is to evaluate the achievement of personalised short- and medium-term objectives of this selective treatment of hypertonia by ultrasound-guided perineural percutaneous cryoneurolysis at the shoulder and elbow, in a population of patients with cerebral palsy with spastic, dyskinetic or dyskinetic, or mixed disorders.

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
12 Years 至 —（Child, Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patients with cerebral palsy treated at the CMCR des Massues, regardless of their functional status as defined by their gross motor function level on the GMFCS (Gross Motor Function Classification System) and their manual ability level on the MACS (Manual Ability Classification System).
  • •Presenting with disabling and/or painful muscle hyperactivity in the shoulder and/or elbow,
  • •Aged over 12 years,
  • •At a therapeutic impasse: contraindicated or refusing surgery, contraindication or insufficient efficacy of oral treatments (analgesics, baclofen, Artane), too short duration of efficacy of toxin injections (<3 months) and/or dose-weight limitation not allowing treatment of all necessary sites.
  • •Patient (and legal representatives in the case of a minor patient or guardian/curator in the case of an adult patient under legal protection measures) who has been informed and has signed the informed consent form for participation in the research,
  • •Patient affiliated with a social security scheme.

排除标准

  • •- Patients who have received a botulinum toxin injection (any location) within 3 months prior to inclusion.
  • •Change in analgesic and/or antispastic treatment within 5 weeks prior to inclusion - Refusal to allow the patient's medical data to be used for research purposes
  • •Contraindication to peripheral motor block and/or cryoneurolysis (haemostasis disorder, skin infection, Raynaud's syndrome, cryoglobulinaemia, cold urticaria).
  • •Pregnant/breastfeeding patients.
  • •Cognitive and/or behavioural disorders that prevent participation in the study or giving consent to participate

研究组 & 干预措施

Cryoneurolise treatment

Experimental

After testing the function following treatment with a motor block, the patient receives an indication for cryoneurolysis treatment.

干预措施: Cryoneurlysis (Procedure)

结局指标

主要结局

Goal Assessment Scale

时间窗: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up

Goal Assessment Scale is an individualized patient-centered outcome measure that quantifies the effects of an intervention based on personal goals. It involves collaboration among patients, caregivers, and healthcare professionals to identify and set meaningful treatment goals. GAS allows for the measurement of the extent to which these goals are met, providing a standardized approach to evaluate progress.

次要结局

  • Clinical tolerability(After cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up)
  • Change in muscle structure(1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up)
  • Muscle hyperactivity(1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up)
  • Active range of motion(1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up)
  • Joint Pain(1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up)
  • Average Patient Satisfaction(1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up)

研究者

发起方
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
申办方类型
Other
责任方
Sponsor

研究点 (2)

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