Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT06194604
Status:
COMPLETED
Last Update Posted:
2024-10-28
First Post:
2023-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Instrument-Assısted Soft Tissue Mobılızatıon in Patients With Operated Distal Radius Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The Investigator and The outcomes assesor different persons'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2023-12-22', 'studyFirstSubmitQcDate': '2023-12-22', 'lastUpdatePostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale', 'timeFrame': 'Day 0', 'description': 'Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels. Activity and rest VAS will be evaluated.'}, {'measure': 'Visual analog scale', 'timeFrame': '4th week', 'description': 'Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels. Activity and rest VAS will be evaluated.'}, {'measure': 'Visual analog scale', 'timeFrame': '6th week', 'description': 'Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels. Activity and rest VAS will be evaluated.'}, {'measure': 'Wrist joint range of motion', 'timeFrame': 'Day 0', 'description': 'Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.'}, {'measure': 'Wrist joint range of motion', 'timeFrame': '4th week', 'description': 'Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.'}, {'measure': 'Wrist joint range of motion', 'timeFrame': '6th week', 'description': 'Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.'}, {'measure': 'Circumference (mm)', 'timeFrame': 'Day 0', 'description': 'Environmental Measurement; Both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.'}, {'measure': 'Circumference (mm)', 'timeFrame': '4th week', 'description': 'Environmental Measurement; Both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.'}, {'measure': 'Circumference (mm)', 'timeFrame': '6th week', 'description': 'Environmental Measurement; Both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Gross Grip Strength:', 'timeFrame': 'Day 0', 'description': 'Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength'}, {'measure': 'Gross Grip Strength:', 'timeFrame': '4th week', 'description': 'Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength'}, {'measure': 'Gross Grip Strength:', 'timeFrame': '6 th week', 'description': 'Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength'}, {'measure': 'Patient-Rated Wrist Evaluation (PRWE) questionnaire', 'timeFrame': 'Day 0', 'description': 'Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire.High scores indicate functional impairment designed to measure wrist pain and disability in activities of daily living.The maximum score that can be obtained from the pain subscale is 50 and the minimum is 0.\n\nThe maximum score that can be obtained from the function subscale is 50 and the minimum is 0.'}, {'measure': 'Patient-Rated Wrist Evaluation (PRWE) questionnaire', 'timeFrame': '4th week', 'description': 'Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire.High scores indicate functional impairment designed to measure wrist pain and disability in activities of daily living.The maximum score that can be obtained from the pain subscale is 50 and the minimum is 0.\n\nThe maximum score that can be obtained from the function subscale is 50 and the minimum is 0.'}, {'measure': 'Patient-Rated Wrist Evaluation (PRWE) questionnaire', 'timeFrame': '6 th week', 'description': 'Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire.High scores indicate functional impairment designed to measure wrist pain and disability in activities of daily living.The maximum score that can be obtained from the pain subscale is 50 and the minimum is 0.\n\nThe maximum score that can be obtained from the function subscale is 50 and the minimum is 0.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Instrument-assisted soft tissue mobilization', 'Distal Radius Fractures', 'edema', 'manuel therapy'], 'conditions': ['Distal Radius Fractures', 'Instrument-assisted Soft Tissue Mobilization']}, 'descriptionModule': {'briefSummary': 'Distal radius fractures are the most common fractures when looking at upper extremity fractures . The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, the annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of them are related to osteoporosis, and if appropriate treatment is not given, they cause loss of work capacity, permanent disability, and limitation in daily activities . There are publications showing that short immobilization and appropriate rehabilitation after surgery provide good clinical results. In cases that are not properly rehabilitated after surgery, there may be an average delay of 12 weeks in returning to normal life and returning to work. When patients who were given early mobilization and rehabilitation after surgery were examined, it was observed that there was a significant improvement in wrist functions, range of motion, and grip strength . Instrumented soft tissue mobilization is a unique soft tissue mobilization combined with active mobility and stretching exercises that is prescribed to increase joint range of motion in patients with musculoskeletal injuries. The various sizes and beveled edges of the stainless steel instruments allow physical therapists to tailor the treatment to different muscle structures that experience myofascial restrictions. Instrumented soft tissue mobilization aims to reduce fascial limitations by increasing circulation. Increases in localized blood flow and soft tissue realignment promote muscle function, increased normal joint movement, and decreased pain.', 'detailedDescription': 'Instrument-assisted soft tissue mobilization (IATSM) has been studied in musculoskeletal system diseases of the upper extremity, lower extremity and spine. The first randomized controlled study examining the effect of the IASTM technique in trigger point treatment was conducted in 2014. A recent review reports that interest in the IASTM technique in musculoskeletal diseases has increased in recent years, but there is not enough evidence to support its use. It has been reported that randomized controlled studies have a high bias rate and are of low quality. In a recent article, IASTM was applied to cases with limited joint range of motion due to elbow fracture. Bhosale et al. They reported its effectiveness on pain, pain-related disability and joint range of motion .\n\nReducing pain and edema after Distal Radius fracture is an important part of postoperative rehabilitation. Various mobilization methods have been applied to this patient population in the postoperative period. There is no study in the literature evaluating the effectiveness of adding IASTM to the postoperative rehabilitation program in patients who underwent surgery for distal radius fractures.\n\nThis study aimed to evaluate the effect of adding IASTM to the postoperative rehabilitation program on pain, edema, joint range of motion and functionality in patients who underwent surgery due to distal radius fracture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having volar plate applied due to distal radius fracture being over 18 years old\n* No major postoperative complications (such as neurovascular injury, hematoma)\n\nExclusion Criteria:\n\n* presence of polytrauma\n* Surgical intervention other than volar plate\n* History of previous limb-related surgery\n* Hemiplegia in the involved limb\n* Contracture in the involved limb'}, 'identificationModule': {'nctId': 'NCT06194604', 'briefTitle': 'Effectiveness of Instrument-Assısted Soft Tissue Mobılızatıon in Patients With Operated Distal Radius Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Ahi Evran University Education and Research Hospital'}, 'officialTitle': 'Effectiveness of Instrument-Assısted Soft Tissue Mobılızatıon in Patients With Operated Distal Radius Fracture', 'orgStudyIdInfo': {'id': '118349'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'In addition to the routine physical therapy program, Instrument-assisted soft tissue mobilization will be applied 3 days a week, for a total of 18 sessions. Each session will last 5 minutes.', 'interventionNames': ['Device: Instrument-assisted soft tissue mobilization', 'Other: Routine rehabilitation programe']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Only the routine physical therapy program will be applied.', 'interventionNames': ['Other: Routine rehabilitation programe']}], 'interventions': [{'name': 'Instrument-assisted soft tissue mobilization', 'type': 'DEVICE', 'description': 'Instrumented soft tissue mobilization is a type of manual therapy method.Istrumented soft tissue mobilization aims to reduce fascial limitations by increasing circulation. Increases in localized blood flow and soft tissue realignment promote muscle function, increased normal joint movement, and decreased pain.', 'armGroupLabels': ['experimental group']}, {'name': 'Routine rehabilitation programe', 'type': 'OTHER', 'description': 'Routine rehabilitation programe consisting of stretching and strengthening exercises will be applied.', 'armGroupLabels': ['Control group', 'experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40100', 'city': 'Kırşehir', 'state': 'Kişrsehşr', 'country': 'Turkey (Türkiye)', 'facility': 'Kirsehir Research and Training Hospital', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}], 'overallOfficials': [{'name': 'Levent Horoz, Asst Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kirsehir Ahi Evran University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahi Evran University Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst Prof', 'investigatorFullName': 'Levent Horoz', 'investigatorAffiliation': 'Ahi Evran University Education and Research Hospital'}}}}