💬In plain words
What the trial is, and whether it could suit you
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 hypothes
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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).
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