Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT05566418
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2022-09-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immediate and Longterm Effects of Mulligan Mobilization With and Without Myofascial Release on Pain,Grip Strength and Function in Patients With Lateral Epicondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014464', 'term': 'Ultrasonic Therapy'}, {'id': 'D000089803', 'term': 'Myofascial Release Therapy'}], 'ancestors': [{'id': 'D003972', 'term': 'Diathermy'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study will be single blinded. Patients will be assessed by a senior Physiotherapist then divided into two groups for treatments. The assessor will be unaware of the treatment given to both groups'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel designed randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-01', 'studyFirstSubmitDate': '2022-09-28', 'studyFirstSubmitQcDate': '2022-10-01', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'change from baseline in grip strength at week 4th', 'timeFrame': 'baseline and 4th week', 'description': 'A handheld dynamometer will be used to assess the maximal grip strength.'}, {'measure': 'change from baseline in functional ability at week 4th', 'timeFrame': 'baseline and 4th week', 'description': 'The Patient-Rated Tennis Elbow Evaluation (PRTEE) is a strong, dependable, and sensitive outcome measure used to identify functional activity participation issues. It consists of 15 questions.'}], 'primaryOutcomes': [{'measure': 'change from baseline in pain at week 4th', 'timeFrame': 'baseline and 4th week', 'description': 'Numeric pain rating scale will be used to assess the pain level. A score of 0 means there is no pain, while a score of 10 means the worst pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lateral Epicondylitis']}, 'descriptionModule': {'briefSummary': 'This study will help to determine the immediate and long term effects of Mulligan mobilization with and without myofascial release on pain, grip strength and function in patients with lateral epicondylitis', 'detailedDescription': 'Tennis elbow patients usually experience diminished grip strength, decreased functional activities, and increased pain, all of which can have a significant impact on everyday activities. Tennis elbow can also be caused by excessive elbow use. The following is a description of the basic clinical manifestation of tennis elbow, as well as the most commonly reported symptoms of people suffering from the condition: Tennis elbow is easily identified and confirmed with a test that produces discomfort, palpable tenderness over the lateral epicondyle facet, resisted wrist extension, resisted middle finger extension, and passive wrist flexion. Tennis elbow is a common elbow disease caused by excessive use. Furthermore, despite some difficulty, the patient must be able to extend his or her wrist and middle finger. The goal of this study is to find out how Mulligan Mobilization with and without myofascial release affects pain, grip strength, and function in people with lateral epicondylitis in the short and long term.\n\nMulligan mobilisation and myofascial release have both been shown to be effective treatments for lateral epicondylitis. The purpose of this study is to look into the short-and long-term advantages of myofascial release and Mulligan mobilisation. No research has been conducted to evaluate whether mulligan mobilisation with or without myofascial release benefits people with lateral epicondylitis in terms of pain, grip strength, and overall function. This study will not only help therapists come up with treatment goals for lateral epicondylitis, also known as tennis elbow, but it will also add credibility to the existing body of literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age group 20 years to 40 years ,both males and females\n2. Diagnosed cases of lateral epicondylitis by senior physiotherapist\n3. Acute and sub-acute cases\n4. Numeric Pain Rating Scale 4 and above\n5. Positive cozen test, Mills test, middle finger extension test\n\nExclusion Criteria:\n\n* H/o\n\n 1. Active medications.\n 2. Dermatitis, malignancy or hazardous to myofascial release.\n 3. Recent trauma, fracture\n 4. Prior surgeries of elbow, tendon ruptures\n 5. Any Neurological conditions like nerve compression\n 6. Swelling around the elbow joint'}, 'identificationModule': {'nctId': 'NCT05566418', 'briefTitle': 'Immediate and Longterm Effects of Mulligan Mobilization With and Without Myofascial Release on Pain,Grip Strength and Function in Patients With Lateral Epicondylitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Lahore'}, 'officialTitle': 'Immediate and Long Term Effects of Mulligan Mobilization With and Without Myofascial Release on Pain, Grip Strength and Function in Patients With Lateral Epicondylitis', 'orgStudyIdInfo': {'id': '898'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group A', 'description': "Group A will get standard therapy and the Mulligan mobilization technique for 12 sessions. A Mulligan mobilization belt will be wrapped around the subject's proximal forearm, close to the elbow joint line, and then wrapped around the therapist's shoulder. This will be done with the therapist's other hand on the distal humerus. The belt will give the subject's forearm a 10-to 15-second lateral glide. The patient will be instructed to constantly extend their wrists while the therapist applies manual resistance to their attempts, and the therapist will continue to work on the patient. When the user can fully extend their wrist without discomfort, the lateral glide will be abolished. Three repeats will be performed, each separated by a fifteen-to twenty-second interval."}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'In addition to the standard treatment, Group B participants will receive 12 sessions of myofascial release technique and Mulligan mobilization. Participants will be instructed to lie supine on the plinth with the afflicted arm internally rotated, elbow slightly flexed and pronated, and palm of hand on the plinth. While standing on the side of the body affected by the ailment being treated, the therapist turned their body to face the affected hand. Myofascial release will be performed on the patient The therapeutic session will last five minutes and will be repeated twice.', 'interventionNames': ['Other: mulligan mobilization', 'Other: myofascial release']}], 'interventions': [{'name': 'mulligan mobilization', 'type': 'OTHER', 'otherNames': ['transcutaneous electric nerve stimulation,Cryo-therapy, Ultrasonic therapy, strengthening exercises'], 'description': "Mulligan mobilization belt will be wrapped around the subject's proximal forearm, close to the elbow joint line, and then wrapped around the therapist's shoulder. This will be done with the therapist's other hand on the distal humerus. The belt will give the subject's forearm a 10-to 15-second lateral glide.", 'armGroupLabels': ['Group B']}, {'name': 'myofascial release', 'type': 'OTHER', 'description': "Myofascial release will be performed on the patient, commencing at the common extensor origin and progressing all the way to the extensor retinaculum in the wrist. The periosteum will be engaged with the fingertips, with contact progressing inferiorly to the common extensor tendon and then to the wrist's extensor retinaculum", 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Sumra Riaz', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Sumra Riaz, MS-PTM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}