Pilot Study on the Efficacy and Tolerability of Cryoneurolysis Treatment in Disabling and/or Painful Hypertonia of the Shoulder and Elbow in Patients With Cerebral Palsy
RecruitingNot applicableNCT07321366
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Cerebral Palsy (CP)
- Interventions
- Procedure: Cryoneurlysis
- Sponsor
- Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
- Start date
- 2025-12-22
- Primary completion
- 2028-12-15
- Sex
- All
- Age range
- from 12 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * \- 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07321366