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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Ultrasound-guided percutaneous cryoneurolysis (CN) is a new, minimally invasive approach that allows the treatment of hypertonia by reversibly blocking nerve conduction secondary to axonotmesis. Although this approach has shown promising results with real benefits in the management of spasticity, its efficacy has not been determined in CP. CN therefore represents a therapeutic alternative between toxin injections and radical surgery in the management of complex tone disorders in CP, for achieving individualised objectives, including pain relief.
CMCR des Massues
Lyon, Rhône, France
RECRUITINGGoal Assessment Scale
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.
Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Clinical tolerability
The evaluation will be carried out, on the one hand, by quantifying the occurrence of adverse events following cryoneurolysis treatment. Once the effects have been confirmed, classification will be carried out by referring to the different grades of clinical classification on the NCI CTCAE version 5.0 scale (Common Terminology Criteria for Adverse Events).
Time frame: After cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Change in muscle structure
The change in muscle structure of the muscles innervated by the cryoneurolysed nerve will be assessed using the modified Heckmatt scale. This scale allows for the evaluation of potential echogenic changes in spastic muscles (echogenicity), indicating the level of fibrotic change.
Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Muscle hyperactivity
The modified Ashworth scale (19,20) will be used to quantify spasticity in patients who exhibit resistance to passive mobilisation (muscle hyperactivity). The average absolute variation in muscle response to stretching applied at given speeds will be assessed using the Modified Tardieu Scale (MTS).
Time frame: 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
Active range of motion (AROM) - movement of a joint performed entirely by the person doing the exercise - and passive range of motion (PROM) - movement applied to a joint solely by another person - in the shoulder and elbow will be measured using a goniometer.
Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Joint Pain
To assess pain in relation to a specific location in the shoulder and/or elbow, several tools can be used. We will preferably use a visual analogue scale from 0 to 10 to assess We prefer to use the Visual Analogue Scale from 0 to 10 to assess the intensity of pain. According to this self-assessment scale, the patient requires pain management if VAS ≥ 4/10.
Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
Average Patient Satisfaction
The average patient satisfaction in relation to the overall sensation in the event of a change will be assessed using a visual analogue scale (VAS), presented vertically to the patient and/or their carer. This scale has two sides (depending on the patient's age and cognitive level), with one side illustrated by emoticons of different colours corresponding to a score of 0: not at all satisfied to 10: perfectly satisfied, and one side in the form of a graduated scale from 0 to 10.
Time frame: 1st visit, after cryoneurolysis treatment, 3 Months follow-up, 6 Months follow up, 9 Months follow-up, 12 Months follow-up
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