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

Launched by CENTRE NATIONAL DE RÉÉDUCATION FONCTIONNELLE ET DE RÉADAPTATION · Jan 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called upper limb nerve cryoneurolysis to see if it is as effective as the usual care for shoulder pain and functional problems caused by muscle stiffness (spasticity) in patients with conditions like stroke, multiple sclerosis, or spinal cord injury. The trial aims to find out if this new treatment can help reduce pain and improve movement in the shoulder, and if it lasts longer than the typical treatment, which involves injections of a medication called botulinum neurotoxin type A (BoNT-A).

To participate, individuals need to be over 18 years old and have certain types of upper limb muscle stiffness and pain that have been stable for at least six months. Participants will receive either the cryoneurolysis treatment or the BoNT-A injection, followed by a rehabilitation program lasting 24 weeks. Throughout the trial, researchers will monitor changes in pain, movement, and overall quality of life. It’s important to know that this study is currently recruiting participants, and those interested should ensure they meet the eligibility criteria before signing up.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • In the investigator's opinion, the subject will be exposed to unacceptable risk by participation.
• • Previous intervention or condition that altered the target neural anatomy of the upper limb.
• • Any injection (neurolytic, sclerosing, anesthesia, etc.) to the upper limb within the last 4 months.
• • Spasticity invasive treatment such as intrathecal baclofen during the trial.
• • Current enrollment in an investigational drug or device study targeting spasticity management.
• • Pregnancy or lactation.
• • Allergy or intolerance to local anesthesia/BoNT-A.
• * Contraindications to BoNT-A administration, such as:
• • Myasthenia Gravis
• • Eaton-Lambert syndrome
• • Possible drug interactions (e.g., aminoglycosides and BoNT-A)
• • Any local skin condition at the treatment site that may adversely affect treatment or outcomes.
• • Chronic medication use (prescription or over-the-counter) that, in the investigator's opinion, would affect study participation or subject safety.
• * Contraindications to cryoneurolysis, including:
• • Diagnosis of cryoglobulinemia
• • Paroxysmal cold hemoglobinuria
• • Cold urticaria
• • Raynaud's disease
• • Any form of peripheral neuropathy
• • Open and/or infected wounds on the affected limb
• • Diagnosis of concomitant progressive neurological diseases such as Amyotrophic Lateral Sclerosis.
• • Any reason, in the investigator's opinion, that the subject may not be suitable for study participation (e.g., history of noncompliance, drug addiction, or any related upper limb injury).