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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

Key facts

Who runs it
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Where
Lyon, FranceSee the site
Trial code
Status
Recruiting
People taking part
40 people, planned
Started
22 Dec 2025
Expected to end
15 Dec 2028
Type of study
Interventional
Treatments tested
  • Cryoneurlysis
Record updated
8 January 2026

Who can take part

Age
12 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • - 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)
  • Cognitive and/or behavioural disorders that prevent participation in the study or giving consent to participate
  • Pregnant/breastfeeding patients

Where in France

  • CMCR des MassuesLyon, FranceContact: Dr Gaucher-PiolaTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Cryoneurolise treatmentTreatment being tested

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

    Treatment: Cryoneurlysis

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
8 January 2026