Ultrasound Guided Cryoneurolysis to Treat Shoulder Pain and Functional Problems Related to Upper Limb Spasticity

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This trial is part of the spastiCRYO clinical research project. The primary objective of this clinical trial is to test the hypothesis: Upper limb nerve cryoneurolysis is non inferior to the usual care and has therapeutic add value in dealing with shoulder pain and functional problems caused by spasticity and motor impairment. It is a non-inferiority study on the referred topic, comparing the therapeutic effect (improvement in function and pain) of cryoneurolysis of selected nerves (lateral pectoral nerve and thoracodorsal nerve) with the usual care: intramuscular botulinum neurotoxin type A (BoNT-A) injection of pectoralis major, teres major and subscapularis muscles. The hypothesis is that cryoneurolysis is not inferior to the usual care in terms of magnitude of the therapeutic effect and might have a therapeutic add-value in terms of duration of that effect. Two secondary hypotheses are firstly, that cryoneurolysis is a safe procedure that can be deployed in a rehabilitation hospital setting with minimum requirements to perform mini-invasive procedures and secondly that selecting patients who might benefit from this treatment is straightforward. To test these hypotheses, the research team will gather, analyse and compare outcome measures data from the endpoints which are the changes along the trial duration in shoulder pain, upper limb function, involved muscles spasticity, shoulder range of motion (abduction and external rotation) level of impairment, and follow-up of potential adverse effects in two independent and equivalent groups of participants who have shoulder pain and functional limitations caused by spasticity and are in a stable phase of their condition. Participants in one group (cryoneurolysis arm) have one session of selected nerves ultrasound and neurostimulation guided cryoneurolysis and participants in the other group (BoNT-A arm) have one session of ultrasound and neurostimulation guided injection of BoNT-A in the pectoralis major, teres major and subscapularis. The participants of the two groups follow an upper limb analogous rehabilitation program for 24 weeks after each intervention. Longitudinal follow-up in the trial will take 24 weeks. In a real-world scenario, within 24 weeks the effect of Bont-A intramuscular injection has already waned, and the procedure should be repeated. Secondary objectives are to compare changes in upper limb sensory function and electroneuromyographic parameters with the intention to understand the cryoneurolysis mechanism of action and the reversibility of this mini-invasive intervention. Changes in quality-of-life dimension of participants is a secondary endpoint as well.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Be over 18 years old.

• Have a clinically and functionally stable condition.

• Present spastic hemiplegia of the upper limb caused by a stroke, traumatic, or hypoxic brain event occurring more than 6 months before the study.

• The paretic upper limb must present significant spastic plegia at the shoulder adductors and/or shoulder internal rotators (≥ 1+ on the Modified Ashworth Scale).

• Have a Visual Analogue Scale (VAS) pain score \> 40/100 mm.

• Have spasticity causing limitations in providing care.

• Have the cognitive capacity to make informed decisions. A comprehensive explanation of the study will be provided orally and in writing to participants and a trusted relative of their choosing.

• Maintain any medications on a stable schedule.

• Accept and have access to an interdisciplinary rehabilitation program and standardized evaluation sessions throughout the study.

Locations
Other Locations
Luxembourg
Rehazenter, Centre National de Rééducation fonctionnelle et de Réadaptation
RECRUITING
Luxembourg
Contact Information
Primary
José A Carvalho Pereira, M.D.
jose.pereira@rehazenter.lu
+35226984010
Backup
Frederic Dierick, PhD
352269894310
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2027-12-12
Participants
Target number of participants: 50
Treatments
Active_comparator: Intramuscular injection of onabotulinumtoxinA
Participants allocated to this group have intramuscular injections, guided by ultrasound and electrical neurostimulation, of BoNT-A (ona botulinum toxin A) to the pectoralis major (75 UI), subscapularis (75 UI) and teres major (50 UI), dilution 100UI/ml. These muscles selection and doses are chosen according to a literature review incriminating these 3 muscles as the responsible for a common spastic pattern of shoulder adduction and internal rotation and contributing to the shoulder pain.
Experimental: Ultrasound-guided Cryoneurolysis with Metrum Cryo-painless S device
The cryoneurolysis intervention is performed by a trained and experienced physician. Ultrasound guided cryoneurolysis to the lateral pectoral nerve and to the thoracodorsal nerve is the intervention in this group. The 3 parts of the pectoral major muscle (clavicular, sternal and costal) innervated by different branches of the lateral pectoral nerve might be targeted as needed80.~The cryoneurolysis device being used is the Cryo-S Painless produced by Metrum, a manufacturer based in Poland. The cryoprobes have a caliber of 1.3 mm. These devices hold medical certification (Conformité Européenne CE) for cryoanalgesia within the European Union.~Technical and certification files are provided to the Regulatory agencies in Luxembourg.~(https://www.metrum.com.pl/produkty/cryo-s-painless-2/?lang=en ). Several precautions steps are taken to prevent the incidence of adverse effects.
Sponsors
Leads: Centre National de Rééducation Fonctionnelle et de Réadaptation

This content was sourced from clinicaltrials.gov