[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"shoulder-stiffness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:shoulder-stiffness":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100576220","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-100576220",false,"NCT06782464","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","Ultrasound Guided Cryoneurolysis to Treat Shoulder Pain and Functional Problems Related to Upper Limb Spasticity","spastiCRYO-UL","Inclusion Criteria:\n\n* Be over 18 years old.\n* Have a clinically and functionally stable condition.\n* Present spastic hemiplegia of the upper limb caused by a stroke, traumatic, or hypoxic brain event occurring more than 6 months before the study.\n* The paretic upper limb must present significant spastic plegia at the shoulder adductors and\u002For shoulder internal rotators (≥ 1+ on the Modified Ashworth Scale).\n* Have a Visual Analogue Scale (VAS) pain score \\> 40\u002F100 mm.\n* Have spasticity causing limitations in providing care.\n* 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.\n* Maintain any medications on a stable schedule.\n* Accept and have access to an interdisciplinary rehabilitation program and standardized evaluation sessions throughout the study.\n\nExclusion Criteria:\n\n* In the investigator's opinion, the subject will be exposed to unacceptable risk by participation.\n* Previous intervention or condition that altered the target neural anatomy of the upper limb.\n* Any injection (neurolytic, sclerosing, anesthesia, etc.) to the upper limb within the last 4 months.\n* Spasticity invasive treatment such as intrathecal baclofen during the trial.\n* Current enrollment in an investigational drug or device study targeting spasticity management.\n* Pregnancy or lactation.\n* Allergy or intolerance to local anesthesia\u002FBoNT-A.\n* Contraindications to BoNT-A administration, such as:\n\n  * Myasthenia Gravis\n  * Eaton-Lambert syndrome\n  * Possible drug interactions (e.g., aminoglycosides and BoNT-A)\n* Any local skin condition at the treatment site that may adversely affect treatment or outcomes.\n* Chronic medication use (prescription or over-the-counter) that, in the investigator's opinion, would affect study participation or subject safety.\n* Contraindications to cryoneurolysis, including:\n\n  * Diagnosis of cryoglobulinemia\n  * Paroxysmal cold hemoglobinuria\n  * Cold urticaria\n  * Raynaud's disease\n  * Any form of peripheral neuropathy\n  * Open and\u002For infected wounds on the affected limb\n* Diagnosis of concomitant progressive neurological diseases such as Amyotrophic Lateral Sclerosis.\n* 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).","ALL","18 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","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\".\n\nIt 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.\n\nTwo 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.\n\nTo 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.\n\nThe 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.\n\nSecondary 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.",[27,28,29,30,31,32,33,34],"Hemiplegia","Spasticity","Shoulder Spasticity","Shoulder Stiffness","Stroke","Multiple Sclerosis","Traumatic Brain Injury","Spinal Cord Injury",[36,37,38,39,40,41],"cryoneurolysis","spasticity","pain","stroke","traumatic brain injury","spinal cord injury","RECRUITING","2026-03-17",{"date":45,"type":46},"2026-03-19","ACTUAL",{"date":48,"type":46},"2024-12-12",{"date":50,"type":21},"2028-12-12",{"name":52,"class":53},"Centre National de Rééducation Fonctionnelle et de Réadaptation","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":65,"conditions":66,"keywords":72,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":54},"100622166","suprascapular-nerve-block-to-improve-tolerance-and-outcomes-of-shoulder-hydrodistension-in-adhesive-capsulitis-100622166","NCT07380087","Suprascapular Nerve Block to Improve Tolerance and Outcomes of Shoulder Hydrodistension in Adhesive Capsulitis","Efficacy of Suprascapular Nerve Block on the Tolerability and Effectiveness of Shoulder Hydrodistension in Patients With Adhesive Capsulitis: A Randomized Clinical Trial","SHINE","Inclusion Criteria\n\n* Adults aged 18 years or older\n* Clinical diagnosis of adhesive capsulitis of the shoulder\n* Persistent pain and functional limitation despite initial conservative treatment\n* Ability to understand study procedures\n* Ability to provide written informed consent\n\nExclusion Criteria\n\n* Known allergy or hypersensitivity to ropivacaine or methylprednisolone\n* Active infection (local or systemic)\n* Uncontrolled coagulopathy or ongoing therapeutic anticoagulation\n* Recent surgery of the affected shoulder\n* Neurological disease affecting the upper limb\n* Pregnancy",{"count":20,"type":21},[24],"Adhesive capsulitis (\"frozen shoulder\") causes significant pain and loss of shoulder mobility. Shoulder hydrodistension is an established treatment that can improve movement and reduce symptoms, but the procedure itself may be painful and difficult for some patients to tolerate.\n\nThis randomized clinical trial will evaluate whether performing a suprascapular nerve block with local anesthetic immediately before hydrodistension can reduce pain during the procedure, improve patient comfort, and potentially enhance clinical outcomes.\n\nParticipants will be randomly assigned to one of two groups:\n\nhydrodistension alone, or\n\nsuprascapular nerve block followed by hydrodistension.\n\nPain, shoulder mobility, functional ability, psychological measures, and quality of life will be assessed at baseline, 1 month, and 3 months after the procedure. The study aims to determine whether adding a suprascapular nerve block provides better tolerability and improved recovery for patients with adhesive capsulitis.",[67,68,69,70,71,30],"Adhesive Capsulitis","Adhesive Capsulitis of Unspecified Shoulder","Adhesive Capsulitis, Shoulder","Frozen Shoulder","Shoulder Pain",[73,74,71,75,76,77,78],"Shoulder Hydrodistension","Suprascapular Nerve Block","Shoulder Mobility","Randomized Clinical Trial","Pain Management","Rehabilitation","NOT_YET_RECRUITING","2026-01-26",{"date":82,"type":46},"2026-02-02",{"date":84,"type":21},"2026-03-01",{"date":86,"type":21},"2028-07-31",{"name":88,"class":53},"Universidade do Porto"]