[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dislocation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dislocation":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,68,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":38,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100646071","phase-1-regenerative-medicine-for-joint-hypermobility-and-instability-100646071",false,"NCT07688096","Regenerative Medicine for Joint Hypermobility and Instability","Regenerative Medicine for Joint Hypermobility and Instability: A Prospective, Open-Label, Single-Arm, Step-Care Clinical Study","Inclusion Criteria:\n\n* Adults age 18 years or older, any gender.\n* Symptomatic joint hypermobility or instability attributable to one of the following:\n\n  1. hEDS diagnosed using the 2017 International Classification of the Ehlers-Danlos Syndromes diagnostic criteria;\n  2. HSD classified using the 2017 framework (generalized, peripheral, localized, or historical HSD) with Beighton scoring; or\n  3. post-traumatic joint instability with ligamentous injury documented by examination and\u002For imaging.\n* Objective evidence of instability or clinically relevant hypermobility at one or more target joints, defined as at least one of:\n\n  1. a positive joint-specific instability provocation test on standardized physical examination;\n  2. generalized hypermobility (Beighton score ≥ 5\u002F9 for adults) or documented joint-specific hypermobility at the target joint; or\n  3. imaging evidence of ligamentous laxity or injury at the target joint (dynamic ultrasound, stress radiograph, or MRI).\n* Pain attributable to the target joint for at least 3 months.\n* Baseline pain score of 4 or greater on a 0-10 numeric rating scale.\n* Failure of conservative treatment, including at least 6 weeks of physical therapy directed at the affected joint(s).\n* Not currently using NSAIDs and willing to avoid NSAIDs during the active treatment period, when clinically appropriate.\n* Able to provide informed consent and to comply with study procedures and follow-up.\n\nAdditional eligibility for the Hyaluronic Acid (HA) alternative pathway - a participant may enter the HA pathway if ALL of the following apply, in addition to the inclusion criteria above:\n\n* Has completed at least one regenerative medicine phase (dextrose, PRP, or doxycycline) and either\n\n  1. was classified as an inadequate responder at the phase decision point (GPI \\\u003C 40%) and declined further regenerative rotation,\n  2. completed all available regenerative phases without adequate response, or\n  3. experienced an adverse reaction during a regenerative phase that, in the investigator's judgment, contraindicates further regenerative treatment.\n* A minimum waiting period of 4 weeks has elapsed since the last regenerative medicine treatment attempted, to allow resolution of post-injection effects before HA administration.\n* The target joint(s) have clinical or imaging features amenable to HA viscosupplementation (e.g., articular\u002Fosteoarthritic pain component identifiable on examination or imaging).\n* No contraindication to HA (see Exclusion Criteria).\n\nExclusion Criteria:\n\n* Impaired decision-making capacity that precludes valid informed consent.\n* Active local or systemic infection.\n* Known allergy or contraindication to study injections, local anesthetics, iodinated contrast (if fluoroscopy is planned), or required procedural materials.\n* Known hypersensitivity or intolerance to tetracycline-class antibiotics, including doxycycline (relevant to the doxycycline treatment phase).\n* Mast cell activation syndrome (MCAS) or other mast cell disorder that, in the investigator's judgment, elevates the risk of injection-related hypersensitivity or systemic reactions.\n* Active autoimmune or systemic inflammatory connective-tissue disease that, in the investigator's judgment, may confound the response to regenerative treatment or increase procedural risk.\n* Known hypersensitivity to sodium hyaluronate or to the specific HA product to be used (Visco-3); active skin disease or infection over the planned injection site; venous or lymphatic stasis in the limb of the planned injection.\n* Active malignancy or anticancer treatment within the prior 12 months; a prior malignancy in documented remission may be enrolled at the investigator's discretion with documented rationale.\n* Uncontrolled diabetes mellitus, defined as HbA1c ≥ 8.5% on the most recent value within the prior 3 months; the investigator may also exclude for other objectively documented diabetes-related procedural or healing risk.\n* Prior joint replacement at the target joint.\n* Planned surgery during study participation.\n* Corticosteroid injection to the target joint(s) within the prior 6 weeks.\n* Concurrent enrollment in another interventional study for the same pain condition.\n* Active litigation or disability claim related to the target condition (to limit secondary-gain confounding of self-reported outcomes).\n* Pregnancy, or unwillingness to undergo pregnancy testing when fluoroscopy is planned (persons of childbearing potential).\n* Inability to comply with study procedures or follow-up.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This clinical trial is designed to evaluate whether a stepwise injection-based treatment approach can reduce pain and improve function in adults with joint hypermobility, connective tissue laxity, and joint instability.\n\nJoint hypermobility occurs when joints move beyond their normal range, often because of looser connective tissue. For some patients, this can contribute to chronic pain, recurrent instability, reduced function, and disability. This study focuses on adults with hypermobile Ehlers-Danlos syndrome (hEDS), hypermobility spectrum disorder (HSD), or joint instability after injury who have already completed physical therapy without adequate relief.\n\nThe main question this study aims to answer is whether the first treatment step, dextrose prolotherapy, can reduce pain by 40% or more two weeks after the second injection.\n\nParticipants will receive treatment in a step-by-step sequence, based on their response:\n\nStep 1: Dextrose prolotherapy A dextrose-based injection used to stimulate a healing response in ligament, tendon, or joint-supporting tissue.\n\nStep 2: Platelet-rich plasma (PRP) An injection prepared from the participant's own blood, designed to support tissue repair and recovery.\n\nStep 3: Doxycycline injections A low-dose injectable treatment used in this study to help protect joint-supporting tissue. It is not being used to treat infection.\n\nAlternative option: Hyaluronic acid injections An injection into the joint that may be offered if the earlier treatment steps do not provide enough improvement.\n\nEach treatment step begins with two injections, given approximately two weeks apart. If a participant improves by 40% or more, they may continue with that treatment pathway. If they do not improve enough, they may be offered the next step in the study.\n\nParticipants will be followed for up to 12 months, with study visits used to monitor pain, function, treatment response, and safety.",[27,28,29,30,31,32,33,34,35,36,37],"Ehlers-Danlos Syndrome Hypermobility Type (hEDS)","Ehlers-Danlos Syndrome (EDS)","Joint Hypermobility","Joint Instability","Hypermobility Spectrum Disorder","Chronic Pain Syndrome","Musculoskeletal Pain","Sprain","Subluxation","Dislocation","Craniocervical Disfunction",[39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,35,54,37,55],"prolotherapy","dextrose prolotherapy","platelet-rich plasma","PRP","doxycycline","regenerative medicine","joint hypermobility","hEDS","hypermobile Ehlers-Danlos syndrome","viscosupplementation","hyaluronic acid","step-care","ligament instability","MMP inhibition","dislocation","CCI","Craniocervical instability","NOT_YET_RECRUITING","2026-07-08",{"date":59,"type":60},"2026-07-10","ACTUAL",{"date":62,"type":20},"2026-07-15",{"date":64,"type":20},"2028-12-31",{"name":66,"class":67},"Manhattan Pain Medicine, PLLC","OTHER",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100377494","phase-2-intranasal-dexmedetomidine-plus-ketamine-for-procedural-sedation-100377494","NCT04195256","Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation","Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation in Children: an Adaptive Randomized Controlled Non-inferiority Multicenter Trial","Ketodex","INCLUSION CRITERIA\n\nGeneral Criteria\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Deemed by treating physician to require procedural sedation\n\nSpecific criteria\n\n1. Children presenting to the paediatric EDs of participating sites age 2-17 years\n2. Weighing up to and including 100 kg\n3. One of the following injuries:\n\n   * Closed forearm fracture\n   * Metacarpal or phalangeal fracture\n   * Dislocation of a shoulder or elbow\n   * Type II supracondylar fracture\n4. Expected to not require more than one dose of IV sedative medication if they were not in the trial (as determined by the procedure physician and not including cast or splint application).\n5. Both nares are fully patent\n6. Physician plans to sedate patient\n\nEXCLUSION CRITERIA\n\n1. Previous hypersensitivity reaction to ketamine or dexmedetomidine including rash, difficulty breathing, hypotension, apnea, or laryngospasm;\n2. Suspected globe rupture;\n3. Concomitant traumatic brain injury with intracranial hemorrhage;\n4. Uncontrolled hypertension;\n5. Nasal bone deformity or septal deviation;\n6. Poor English or French fluency in the absence of native language interpreter;\n7. American Society of Anesthesiologists (ASA) class 3 or greater;\n8. Previous diagnosis of schizophrenia or active psychosis as per the treating physician\n9. Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction;\n10. More than one fracture or dislocation requiring reduction;\n11. Hemodynamic compromise as per the treating physician;\n12. Glasgow coma score \\\u003C 15;\n13. Previous sedation with ketamine or hematoma block within 24 hours;\n14. Fracture is comminuted or associated with a dislocation;\n15. Participant has undergone a hematoma block within 24 hours;\n16. Obstructive sleep apnea\n17. Previous enrollment in the trial;\n18. Suspected pregnancy\n19. Congenital heart disease or known cardiac dysrhythmia\n20. Known or suspected hepatic impairment\n21. Known renal insufficiency\n22. Uncorrected mineralocorticoid deficiency","2 Years","17 Years",{"count":79,"type":20},400,[24,81],"PHASE3","Orthopedic injuries comprise more than 10% of ED visits in children and 25 to 50% of children will sustain a fracture before age 16 years. Distal radius fractures account for 20-32% of fractures in children, making them the most common fracture type. Between 20 and 40% of extremity fractures in children require a closed reduction, often necessitating procedural sedation and analgesia (PSA). Intravenous (IV) ketamine is the most commonly used sedative agent used to perform a closed reduction. However, children rate IV insertion as the most painful hospital experience, second only to the injury itself. IV insertion can be more technically difficult in children because of smaller veins and lack of cooperation, often leading to multiple IV attempts. A combination of intranasal (IN) dexmedetomidine plus ketamine (IN Ketodex) may provide effective sedation for children undergoing a closed reduction without the distress and pain related to IV insertion. A less painful experience has been found to correlate with child satisfaction which may reduce caregiver anxiety and improve the therapeutic relationship with the health care team. This study is a multi-centre, two-arm, randomized, blinded, controlled, non-inferiority trial designed to test the hypothesis that IN Ketodex is non-inferior to intravenous (IV) ketamine with respect to depth of sedation as measured using the Pediatrics Sedation State Scale (PSSS).",[84,36],"Fracture","RECRUITING","2024-11-01",{"date":88,"type":60},"2024-11-05",{"date":90,"type":60},"2020-03-11",{"date":92,"type":20},"2026-12",{"name":94,"class":67},"Naveen Poonai",6,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":76,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100548810","virtual-reality-in-the-management-of-painful-or-anxiety-provoking-procedures-in-emergency-departments-100548810","NCT06425835","Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments","Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments: (Open Prospective Observational Study)","VR","Inclusion Criteria:\n\n* Patients aged 09 and 24 years\n* suturing a wound\n* changing a dressing\n* lumbar puncture,\n* peripheral venous line\n* blood test\n* intramuscular injection\n* reduction of a fracture\n* casting or plastering.\n\nExclusion Criteria:\n\n* impaired consciousness\n* epilepsy\n* wound\u002Finfection covering the helmet area\n* headache\n* intellectual\u002Fmental retardation\n* nausea, vomiting\n* patient already included in the protocol\n* pain requiring immediate medical attention. analgesic (VAS \\>5 and described as intolerable).","9 Years","24 Years",{"count":107,"type":20},300,"OBSERVATIONAL","Study and evaluate the effectiveness of virtual reality in pain management.",[111,36,112],"Pain and Anxiety","Suture","2024-05-21",{"date":115,"type":60},"2024-05-22",{"date":117,"type":20},"2024-08-15",{"date":119,"type":20},"2026-12-15",{"name":121,"class":67},"University of Monastir"]