Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT07263256
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2025-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Median Nerve Decompression for Complex Regional Pain Syndrome: A Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}, {'id': 'D002607', 'term': 'Charcot-Marie-Tooth Disease'}, {'id': 'D012019', 'term': 'Reflex Sympathetic Dystrophy'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D015417', 'term': 'Hereditary Sensory and Motor Neuropathy'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment Group A: Lesion-specific correction Group B: Median nerve decompression'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-11-23', 'studyFirstSubmitQcDate': '2025-11-23', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain (VAS Score)', 'timeFrame': 'Baseline, 10-12 days post-op, 3 months post-op', 'description': 'Change in pain intensity measured using the visual analogue scale (0-10) to evaluate the clinical effect of surgical intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complex Regional Pain Syndrome', 'CRPS Type I', 'Neuropathic Pain', 'Median Nerve Decompression', 'Peripheral Nerve Surgery', 'Upper Limb Pain', 'Nerve Entrapment', 'Chronic Pain', 'Hand Surgery'], 'conditions': ['Complex Regional Pain Syndrome I (CRPS I)', 'Nerve Entrapment Syndrome']}, 'referencesModule': {'references': [{'pmid': '19557864', 'type': 'BACKGROUND', 'citation': 'Oaklander AL, Fields HL. Is reflex sympathetic dystrophy/complex regional pain syndrome type I a small-fiber neuropathy? Ann Neurol. 2009 Jun;65(6):629-38. doi: 10.1002/ana.21692.'}, {'type': 'BACKGROUND', 'citation': 'Goebel A, Barker CH, Turner-Stokes L, et al. Complex regional pain syndrome in adults: UK guidelines for diagnosis, referral and management. Rheumatology (Oxford). 2018;57(8):1405-1436. PMID: 29648652'}, {'pmid': '20493633', 'type': 'BACKGROUND', 'citation': 'Harden NR, Bruehl S, Perez RSGM, Birklein F, Marinus J, Maihofner C, Lubenow T, Buvanendran A, Mackey S, Graciosa J, Mogilevski M, Ramsden C, Chont M, Vatine JJ. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010 Aug;150(2):268-274. doi: 10.1016/j.pain.2010.04.030. Epub 2010 May 20.'}]}, 'descriptionModule': {'briefSummary': 'This clinical study evaluates the effectiveness of surgical treatment in patients with upper-limb complex regional pain syndrome (CRPS) diagnosed according to the Budapest criteria. Seventy-four patients were assessed between 2014 and 2023. Patients with identifiable structural pathology underwent lesion-specific surgical correction, while those without detectable lesions but with neuropathic nocturnal pain underwent decompression of the median nerve. Pain intensity was measured using the visual analogue scale (VAS) preoperatively, at 10-12 days, and at three months. The study aims to determine the speed and magnitude of pain improvement after targeted surgical intervention.', 'detailedDescription': 'Complex regional pain syndrome (CRPS) is a multifactorial neuropathic pain disorder that can occur after trauma or surgery and is often resistant to conservative treatment. Increasing evidence suggests that in a subset of patients, peripheral mechanical factors contribute significantly to symptom generation. This prospective clinical study evaluated the outcomes of targeted surgical treatment in patients with CRPS of the upper limb who met the Budapest diagnostic criteria.\n\nFrom 2014 to 2023, seventy-four patients were examined. Thirty-eight patients presented with identifiable structural pathology, such as hardware impingement, neuroma, tendon adhesion, or scar tethering, and underwent lesion-specific surgical correction. Thirty-six patients had no detectable structural lesion but reported nocturnal neuropathic pain suggestive of median nerve irritation; these patients underwent decompression of the median nerve. Pain intensity was measured using the visual analogue scale (VAS) before surgery, at suture removal (10-12 days), and at three months postoperatively.\n\nPatients with identifiable mechanical pathology demonstrated substantial improvement, with an average 7.2-point VAS reduction after six months. Patients who underwent median nerve decompression showed rapid and marked pain reduction, improving by 7.1 points within 10-12 days and 8.6 points within three months. Acute CRPS cases improved more than chronic ones, indicating an early therapeutic window before central sensitization becomes dominant. Only one chronic case failed to improve. The results suggest that timely surgical assessment and correction of peripheral nerve or soft-tissue factors may lead to rapid and significant clinical recovery in selected CRPS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed Complex Regional Pain Syndrome (CRPS) according to Budapest criteria\n* Age ≥ 18 years\n* Persistent symptoms despite previous conservative treatment\n* Ability to understand the study information and provide informed consent\n* Ability to adhere to postoperative follow-up\n\nExclusion Criteria:\n\n* Active local or systemic infection\n* Severe uncontrolled psychiatric illness\n* Coagulopathy or anticoagulation therapy contraindicating surgery\n* Pregnancy\n* Previous extensive surgical interventions on the same site interfering with planned procedure\n* Inability to comply with follow-up\n* Any other condition that, in the opinion of the investigator, makes participation unsafe'}, 'identificationModule': {'nctId': 'NCT07263256', 'acronym': 'CRPS-SURG', 'briefTitle': 'Median Nerve Decompression for Complex Regional Pain Syndrome: A Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'Charles University, Czech Republic'}, 'officialTitle': 'Surgical Treatment of Complex Regional Pain Syndrome by Median Nerve Decompression and Lesion-Specific Correction: A Clinical Study', 'orgStudyIdInfo': {'id': 'CRPS-MND-2014-2023'}, 'secondaryIdInfos': [{'id': 'MH CZ-DRO-VFN64165', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Health of the Czech Republic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm A - Lesion-Specific Surgical Correction', 'description': 'Surgical correction of identifiable structural pathology, including hardware impingement, neuroma, tendon adhesion, scar tethering, or other mechanical causes of CRPS.', 'interventionNames': ['Procedure: Lesion-Specific Surgical Correction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B - Median Nerve Decompression', 'description': 'Open decompression of the median nerve performed in patients without identifiable lesions but with nocturnal neuropathic pain suggestive of median nerve irritation.', 'interventionNames': ['Procedure: Median Nerve Decompression']}], 'interventions': [{'name': 'Lesion-Specific Surgical Correction', 'type': 'PROCEDURE', 'description': 'Surgical correction of identifiable structural pathology, including hardware impingement, neuroma, tendon adhesion, scar tethering, or other mechanical causes of complex regional pain syndrome of the upper limb.', 'armGroupLabels': ['Arm A - Lesion-Specific Surgical Correction']}, {'name': 'Median Nerve Decompression', 'type': 'PROCEDURE', 'description': 'Surgical correction of identifiable structural pathology, including hardware impingement, neuroma, tendon adhesion, scar tethering, or other mechanical causes of complex regional pain syndrome of the upper limb.', 'armGroupLabels': ['Arm B - Median Nerve Decompression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '592 31', 'city': 'Nové Město na Moravě', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Hospital Nové Město Na Moravě', 'geoPoint': {'lat': 49.56144, 'lon': 16.07418}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jitka Fricova', 'class': 'OTHER'}, 'collaborators': [{'name': 'Charles University, Czech Republic', 'class': 'OTHER'}, {'name': 'Ministry of Health, Czech Republic', 'class': 'OTHER_GOV'}, {'name': 'General University Hospital, Prague', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Pain Management Center,MD, PhD. Ass.prof.', 'investigatorFullName': 'Jitka Fricova', 'investigatorAffiliation': 'Charles University, Czech Republic'}}}}