Cryoneurolysis for shoulder pain and spasticity management
Ultrasound Guided Cryoneurolysis to Treat Shoulder Pain and Functional Problems Related to Upper Limb Spasticity
This study tests if a new cold treatment for shoulder pain can help people with hemiplegia feel better and move better compared to the usual botulinum injections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre National de Rééducation Fonctionnelle et de Réadaptation Academic / other |
| Locations | 1 site (Luxembourg) |
| Trial ID | NCT06782464 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of upper limb nerve cryoneurolysis compared to standard care, which involves botulinum neurotoxin injections, for treating shoulder pain and functional impairments caused by spasticity in patients with hemiplegia. The study aims to determine if cryoneurolysis is not only as effective as the usual care but also offers additional therapeutic benefits, particularly in terms of the duration of pain relief and functional improvement. Participants will undergo a thorough evaluation and receive interdisciplinary rehabilitation throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with spastic hemiplegia due to a stroke or similar brain injury, experiencing significant shoulder spasticity and pain.
Not a fit: Patients with conditions that do not involve spastic hemiplegia or those who are not cognitively able to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide longer-lasting relief from shoulder pain and improved function for patients with spasticity.
How similar studies have performed: While the specific approach of cryoneurolysis is novel, similar studies using neurotoxin injections have shown success in managing spasticity and pain.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Luxembourg
- Rehazenter, Centre National de Rééducation fonctionnelle et de Réadaptation — Luxembourg, Luxembourg (Recruiting)
Study contacts
- Study coordinator: José A Carvalho Pereira, M.D.
- Email: jose.pereira@rehazenter.lu
- Phone: +35226984010
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.