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.
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).
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.
Parallel
Treatment
Procedure/SurgeryTreatment
Change in active Range of motion shoulder
Active Range of Motion (AROM) measure in angles (Deg) at the shoulder assesses joint mobility through voluntary movement by the patient. The healthcare professional instructs the patient to perform the following motions: Flexion: Arm moves forward and upward. Extension: Arm moves backward. Abduction: Arm lifts outward to the side. Adduction: Arm moves across the body. Internal Rotation: Arm rotates inward (e.g., hand behind back). External Rotation: Arm rotates outward (e.g., hand behind head). The clinician observes for range, quality, symmetry, and compensatory movements. A goniometer measures the motion in degrees, compared to normative or baseline values. AROM helps identify muscle strength, joint limitations, and functional deficits, providing a reliable outcome measure in rehabilitation.
Change in passive range of motion of shoulder
Passive Range of Motion (PROM), measured in angles (Deg) performed by a healthcare professional, assesses joint mobility in the shoulder. The clinician gently moves the shoulder through its full range while the patient remains relaxed, measuring: Flexion (forward arm movement) Extension (backward arm movement) Abduction (arm movement away from the body) Adduction (arm movement toward the body) Internal rotation (arm rotates inward) External rotation (arm rotates outward). A goniometer records the motion in degrees, compared to normative values or baseline measurements. PROM is essential for identifying joint stiffness, contractures, or spasticity and tracking mobility changes over time, making it a reliable outcome measure in rehabilitation.
Change in muscle tone muscles controlling the shoulder
Modified Ashworth scale, number in a scale from 0 to 4. score: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in nociceptive pain: Visual analogue scale
The Visual Analog Scale (VAS) measured in mm in a 100 mm bar, is a simple, widely used tool for assessing nociceptive pain intensity. Since you are using a vertical bar with the maximum pain at the top, the scale will appear as a straight vertical line, typically 10 centimeters long. It is anchored by two descriptors: At the bottom: "No Pain" At the top: "Worst Imaginable Pain" Patients are instructed to mark a point on the vertical line that corresponds to the intensity of their current pain. This mark reflects their subjective experience of pain at that moment. To quantify the pain level, measure the distance from the bottom of the line to the patient's mark, usually in centimeters or millimeters. This measurement provides a numerical value of pain intensity on a scale from 0 to 10.
Upper limb fonction - Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) measured in numbers in a scale 0-66. Upper Limb part is a standardized tool to measure changes in upper limb function after stroke or neurological injury. It evaluates motor recovery across shoulder, elbow, wrist, and hand movements. Components: Volitional Movement: Assess active motions (e.g., flexion, extension, abduction, and rotation) of the upper limb. Coordination/Speed: Perform finger-to-nose or repetitive tasks. Reflex Activity: Evaluate reflex presence at specific joints. Each item is scored on a 3-point scale: 0: Cannot perform. 1. Partial movement. 2. Full movement. The maximum score for the upper limb is 66 points. Higher scores indicate better motor function. The FMA is sensitive to functional changes over time, making it a reliable outcome measure in rehabilitation.
change in Quality of Life
The SF-36 (Short Form-36) is a standardized questionnaire used to measure changes in quality of life across 8 domains: Physical Functioning Role Limitations (Physical) Bodily Pain General Health Vitality Social Functioning Role Limitations (Emotional) Mental Health Patients rate their experiences over the past 4 weeks using Likert scales or yes/no responses. Scores for each domain are transformed into a 0-100 scale, with higher scores indicating better quality of life. The SF-36 provides a physical component summary (PCS) and a mental component summary (MCS), allowing for comprehensive evaluation of changes in overall health. It is widely used in clinical and research settings for tracking improvements or declines over time.
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