Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06913920
Status:
RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015915', 'term': 'Motion Therapy, Continuous Passive'}, {'id': 'D048228', 'term': 'Intermittent Pneumatic Compression Devices'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to one of two parallel arms. The Mechanical Modality Group (MMG) receives both mechanical devices (CPM and IPC) integrated with standard therapy. The Standard Care Group (SCG) receives the same standard therapy without the addition of mechanical modalities.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edema Volume', 'timeFrame': 'Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.', 'description': 'Edema of the wrist/forearm will be quantitatively measured using a volumeter method. Lower volumes are indicative of reduced swelling.'}, {'measure': 'Pain Intensity', 'timeFrame': 'Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.', 'description': 'Pain is measured using the Numeric Pain Rating Scale (NPRS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).'}], 'secondaryOutcomes': [{'measure': 'Wrist/Forearm Range of Motion (ROM)', 'timeFrame': 'Measured at baseline, 6 weeks, and 3 months postoperatively.', 'description': 'Active ROM is measured using a standard goniometer. Improvements in ROM indicate better recovery of function.'}, {'measure': 'Grip Strength', 'timeFrame': 'Assessed at baseline, 6 weeks, and 3 months postoperatively.', 'description': 'Evaluated using a calibrated dynamometer. Increased grip strength is suggestive of improved functional recovery.'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'Continuously monitored from baseline to the 3-month follow-up.', 'description': 'All adverse events, including skin irritation or device intolerance, will be monitored and recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distal Radius Fractures']}, 'descriptionModule': {'briefSummary': 'This single-blinded, randomized controlled trial (RCT) will evaluate the added benefit of mechanical modalities (continuous passive motion (CPM) and intermittent pneumatic compression (IPC)) when integrated into standard therapy for managing postoperative edema and pain in patients undergoing distal radius fracture (DRF) fixation. The primary outcomes are edema volume (measured via volumeter) and pain intensity (Numeric Pain Rating Scale, NPRS) at 6 weeks post-operation. Secondary outcomes include wrist/forearm range of motion (ROM), grip strength, Patient-Rated Wrist Evaluation (PRWE), and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18 years or older. Undergoing surgical treatment for distal radius fracture with stable internal fixation.\n\nAble to initiate formal rehabilitation approximately 2 weeks postoperatively. Willing and able to attend in-clinic therapy sessions at the outpatient hand therapy center.\n\nExclusion Criteria:\n\nUnstable fixation or need for further surgical intervention. Pre-existing conditions that would significantly affect upper limb function (e.g., severe arthritis, neurological disorders).\n\nHistory of skin conditions or allergies that contraindicate the use of mechanical devices.\n\nAny contraindication to mechanical modalities (for example, severe peripheral vascular disease).\n\nInability to comply with study procedures or follow-up visits. Pregnant or breastfeeding individuals.'}, 'identificationModule': {'nctId': 'NCT06913920', 'briefTitle': 'Mechanical Modalities vs. Standard Care for Edema and Pain Management After DRF Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Al Hayah University In Cairo'}, 'officialTitle': 'A Two-Arm, Single-Blinded Randomized Controlled Trial Evaluating the Effectiveness of Mechanical Modalities Combined With Standard Therapy Versus Standard Therapy Alone for Edema and Pain Management After Distal Radius Fracture Fixation', 'orgStudyIdInfo': {'id': 'MMDRF2025-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mechanical Modality Group (MMG)', 'description': 'Participants in the MMG will undergo a combined intervention that utilizes mechanical modalities in addition to a standard rehabilitation program.', 'interventionNames': ['Device: Continuous Passive Motion (CPM)', 'Device: Intermittent Pneumatic Compression (IPC)', 'Behavioral: Standard Therapy Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care Group (SCG)', 'description': 'Participants in the SCG will receive the standard rehabilitation program alone without the application of mechanical devices.', 'interventionNames': ['Behavioral: Standard Therapy Program']}], 'interventions': [{'name': 'Continuous Passive Motion (CPM)', 'type': 'DEVICE', 'description': "Materials: A CPM device configured for wrist flexion-extension with an adjustable range of motion set between 0° and 30°.\n\nProcedure:\n\nThe participant's wrist is gently secured in the device. The CPM device is programmed to deliver 20 minutes of continuous, passive motion through the set range.\n\nDevice settings (e.g., speed) may be modified if the participant reports pain \\>4/10 on the NPRS.", 'armGroupLabels': ['Mechanical Modality Group (MMG)']}, {'name': 'Intermittent Pneumatic Compression (IPC)', 'type': 'DEVICE', 'description': 'Materials: An IPC sleeve designed for the forearm-to-hand region with a baseline compression setting of approximately 30 mmHg.\n\nProcedure:\n\nAfter CPM treatment, the IPC device is applied to the affected limb. The sleeve provides 15 minutes of intermittent compression with programmed intervals of inflation and deflation.\n\nCompression levels may be adjusted based on participant comfort and pain ratings.', 'armGroupLabels': ['Mechanical Modality Group (MMG)']}, {'name': 'Standard Therapy Program', 'type': 'BEHAVIORAL', 'description': 'Procedures:\n\nActive/active-assisted wrist/forearm range of motion exercises led by a certified hand/physical therapist.\n\nProgressive grip-strengthening exercises using resistance bands or putty. Manual edema management techniques, including gentle massage and manual lymphatic drainage, as well as scar mobilization if needed.', 'armGroupLabels': ['Mechanical Modality Group (MMG)', 'Standard Care Group (SCG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12311', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed ElMeligie, Ph.D', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@ahuc.edu.eg', 'phone': '01159880001', 'phoneExt': '+20'}], 'facility': 'Faculty of Physical Therapy, Al Hayah University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al Hayah University In Cairo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}