Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06271720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-01-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2024-01-19', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'pre treatment and after 4 weeks', 'description': 'pain intensity will be measured by a visual analog scale, the scale is marked from 0 to 10 while 0 represents no pain and 10 represents intolerable pain'}, {'measure': 'pain pressure threshold', 'timeFrame': 'pre treatment and after 4 weeks', 'description': 'pressure threshold measured by pressure algometer'}, {'measure': 'shoulder range of motion', 'timeFrame': 'pre treatment and after 4 weeks', 'description': 'shoulder flexion and abduction range of motion will be measured by inclinometer'}, {'measure': 'shoulder functional level', 'timeFrame': 'pre treatment and after 4 weeks', 'description': 'The functional level of the shoulder will be measured by shoulder pain and disability index. the index consists of subscales that measure how much shoulder pain interferes with the functional activity of daily living'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Impingement']}, 'descriptionModule': {'briefSummary': 'This study will be conducted To evaluate the effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome', 'detailedDescription': 'HYPOTHESES\n\nIt will be hypothesized that:\n\n1. There will be no statistically significant effect of Visceral Manipulation on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, or function in shoulder impingement syndrome\n2. There will be no statistically significant effect of the Integrated Neuromuscular Inhibition Technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, or function in shoulder impingement syndrome.\n3. There will be no statistically significant difference in the effect of visceral manipulation versus the integrated neuromuscular inhibition technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome.\n\nThis study will be conducted to answer the following questions:\n\nIs there an effect of Visceral Manipulation versus Integrated Neuromuscular Inhibition Technique on the upper fiber of the trapezius on pain intensity, pain threshold, shoulder range of motion, and function in shoulder impingement syndrome?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* -active myofascial trigger points in the upper trapezius muscle, and chronic Pain lasting more than 12 weeks\n* BMI between 25 and 30 Kg/m².\n\nExclusion Criteria:\n\n* a previous fracture in the cervical spine or shoulder surgery\n* acute inflammatory condition.\n* Malignant tumor.\n* Multiple osteophytes.\n* Cervical posture abnormalities.\n* Osteoporosis.'}, 'identificationModule': {'nctId': 'NCT06271720', 'briefTitle': 'Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Egyptian Chinese University'}, 'officialTitle': 'Impact of Visceral Manipulation Versus Integrated Neuromuscular Inhibition Technique in Shoulder Impingement Syndrome', 'orgStudyIdInfo': {'id': 'faculty of physical therapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'visceral manipulation', 'description': 'Palpation will be applied and the pressure will directly to the skin, into the direction of restriction just until resistance (tissue barrier) is felt. Once found, the collagenous barrier will be engaged for 90 to 120 seconds for each technique without sliding over the skin or forcing the tissue until the fascia complex starts to yield and a sensation of softening is achieved.', 'interventionNames': ['Other: visceral manipulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'integrated neuromuscular inhibition', 'description': 'The practitioner first identifies TrPs to be treated within the upper trapezius muscle. The subjects will be placed in a supine position. Their arm will be positioned in slight shoulder abduction with the elbow bent and their hand resting on their stomach. Using a pincer grasp, the practitioner will move throughout the fibers of the upper trapezius and make note of any active TrPs. Once the TrPs were identified, treatment began. The first technique applied will be ischemic compression. The therapist again utilized a pincer grasp, placing the thumb and index finger over the active TrP. Slow, increasing levels of pressure will be applied until the tissue resistance barrier is identified. The pressure will be maintained until a release of the tissue barrier is felt. At that time, pressure will again be applied until a new barrier is felt. This process will be repeated until tension or tenderness is unable to be identified or 90 seconds have elapsed.', 'interventionNames': ['Other: integrated neuromuscular inhibition']}], 'interventions': [{'name': 'visceral manipulation', 'type': 'OTHER', 'description': 'visceral manipulation: A palpation technique will be applied till the barrier is felt and it will be applied until release is felt.\n\nintegrated neuromuscular inhibition: ischemic compression will be applied to trigger point of upper trapezius', 'armGroupLabels': ['visceral manipulation']}, {'name': 'integrated neuromuscular inhibition', 'type': 'OTHER', 'description': 'It involves applying direct sustained digital pressure to the TrP with sufficient force over dedicated time duration, to slow down the blood supply and relieve the tension within the involved muscle. The pressure is gradually applied, maintained and the gradually released', 'armGroupLabels': ['integrated neuromuscular inhibition']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Noha Elserty', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Noha Elserty', 'investigatorAffiliation': 'Egyptian Chinese University'}}}}