Cryoneurolysis for disabling or painful shoulder and elbow hypertonia in cerebral palsy
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
This project will try ultrasound-guided perineural cryoneurolysis to reduce disabling or painful shoulder and elbow muscle tightness in people with cerebral palsy aged 12 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française Academic / other |
| Locations | 1 site (Lyon, Rhône) |
| Trial ID | NCT07321366 on ClinicalTrials.gov |
What this trial studies
This single-center pilot offers ultrasound-guided percutaneous perineural cryoneurolysis targeted to nerves supplying spastic or dyskinetic muscles around the shoulder and elbow in people with cerebral palsy. Participants are patients treated at the CMCR des Massues who have disabling or painful hypertonia and who have reached a therapeutic impasse with oral drugs, botulinum toxin, or surgery. The protocol sets personalized short- and medium-term functional goals and collects clinical and patient-reported outcomes to characterize tolerability and preliminary efficacy. The focus is feasibility, safety, and estimating effect sizes to inform larger studies.
Who should consider this trial
Good fit: People with cerebral palsy aged 12 years or older who have disabling or painful hypertonia of the shoulder and/or elbow and who have contraindications to, inadequate response to, or unacceptable duration/coverage from standard therapies are ideal candidates.
Not a fit: Patients with fixed bony contractures or predominant generalized nonfocal spasticity, active infection or significant bleeding disorders, or those under 12 years old are unlikely to benefit from this focal cryoneurolysis approach.
Why it matters
Potential benefit: If successful, this approach could provide a localized, minimally invasive option to reduce pain and muscle hypertonia and improve function when other treatments have failed or are not suitable.
How similar studies have performed: Small case series and observational reports indicate cryoneurolysis can reduce spasticity and pain, but randomized data and pediatric-specific evidence for shoulder/elbow application in cerebral palsy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lyon, Rhône
- CMCR des Massues — Lyon, Rhône, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.