[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"median-neuropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:median-neuropathy":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100637199","hydrodissection-with-neuroprolotherapy-versus-open-release-for-carpal-tunnel-syndrome-100637199",false,"NCT07576803","Hydrodissection With Neuroprolotherapy Versus Open Release for Carpal Tunnel Syndrome","Ultrasound-Guided Hydrodissection Combined With Neuroprolotherapy Versus Open Carpal Tunnel Release in Patients With Carpal Tunnel Syndrome: A Randomized, Parallel-Group, Non-Inferiority Trial","HN-CTS","Inclusion Criteria:\n\n* Adults aged 18 years or olde\n* Clinical diagnosis of carpal tunnel syndrome\n* Presence of symptoms for at least 3 months\n* Failure of conservative treatment, including splinting, medication, or physical therapy\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Previous carpal tunnel surgery in the affected limb\n* Severe thenar muscle atrophy\n* Cervical radiculopathy or proximal nerve compression\n* Pregnancy\n* Coagulopathy or current use of anticoagulants contraindicating procedures\n* Local infection at the intervention site\n* Inability to comply with follow-up","ALL","18 Years","70 Years",{"count":21,"type":22},72,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is a randomized controlled, parallel-group, non-inferiority trial designed to compare ultrasound-guided hydrodissection combined with neuroprolotherapy versus open carpal tunnel release in patients with carpal tunnel syndrome. Participants will be randomly allocated in a 1:1 ratio using a computer-generated sequence, with allocation concealment ensured by sequentially numbered, sealed, opaque envelopes. Outcome assessment and statistical analysis will be performed by blinded evaluators.\n\nThe experimental group will undergo a single session of ultrasound-guided hydrodissection with perineural injection of a solution composed of zero point nine percent sodium chloride and five percent dextrose, combined with local anesthetic and betamethasone, aiming to promote mechanical release of the median nerve and modulation of the inflammatory process. The control group will undergo standard open carpal tunnel release through surgical division of the transverse carpal ligament under sterile conditions.\n\nParticipants will be assessed at baseline, and at 1, 3, and 6 months after intervention. The primary outcome is the change in the Boston Carpal Tunnel Questionnaire score at 3 months. A non-inferiority margin of 0.5 points will be adopted. Secondary outcomes include pain intensity measured by visual analog scale, grip strength, pinch strength, median nerve cross-sectional area assessed by ultrasound, time to return to work, and procedure-related complications.\n\nStatistical analysis will follow the intention-to-treat principle, with complementary per-protocol analysis. Between-group comparisons will be conducted using analysis of covariance adjusted for baseline values, and repeated measures will be analyzed using mixed-effects models. The hypothesis is that the minimally invasive intervention is non-inferior to surgical decompression, with potential advantages in recovery and morbidity.",[28,29],"Carpal Tunnel Syndrome","Median Neuropathy",[31,32,33,28,34,35,36,37,38],"Hydrodissection","Perineural injection","Ultrasound-guided procedure","Median nerve decompression","Minimally invasive treatment","Open carpal tunnel release","Nerve entrapment","Functional outcomes","NOT_YET_RECRUITING","2026-05-04",{"date":42,"type":43},"2026-05-08","ACTUAL",{"date":45,"type":22},"2026-05-02",{"date":47,"type":22},"2027-08-31",{"name":49,"class":50},"Universidade Federal de Pernambuco","OTHER"]