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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorCentre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

- 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.

Trial design

Treatments tested in this trial

  • Cryoneurlysis

Treatment groups

40 Participants
are divided into 1 treatment group