Cryoneurolysis for shoulder pain and spasticity management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.