Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-28 @ 8:18 PM
Study NCT ID:
NCT05064033
Status:
UNKNOWN
Last Update Posted:
2021-10-01
First Post:
2021-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pragmatic Posterior Capsular Stretch Versus Sleeper Stretch in Subject With Shoulder Pathologies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial(double-blind)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-03-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shoulder range of motion', 'timeFrame': '6 weeks', 'description': 'shoulder range of motion will be measured in degrees by using digital inclinometer'}, {'measure': 'shoulder pain', 'timeFrame': '6 weeks', 'description': 'shoulder pain will be measured by numeric pain rating scale'}], 'secondaryOutcomes': [{'measure': 'Shoulder related quality of life', 'timeFrame': '6 weeks', 'description': 'quality of life will be measured by using HHIRS quality of life questionnaire'}, {'measure': 'Shoulder disability', 'timeFrame': '6 weeks', 'description': 'Shoulder disability will be measured by Shoulder Pain And Disability Index Urdu (SPADI-U)'}, {'measure': 'satisfaction level of patient', 'timeFrame': '6 weeks', 'description': 'satisfaction level of patient will be measured by Questionnaire for satisfaction level of patient receving this intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleeper stretch', 'shoulder pathologies', 'Posterior capsular tightness', 'shoulder range of motion', 'pragmatic posterior capsular stretch', 'pragmatic intervention'], 'conditions': ['Shoulder Impingement', 'Shoulder Arthritis', 'Shoulder Injuries', 'Shoulder Capsulitis', 'Shoulder Bursitis', 'Shoulder Pain Chronic']}, 'referencesModule': {'references': [{'pmid': '12763431', 'type': 'BACKGROUND', 'citation': 'Michener LA, McClure PW, Karduna AR. Anatomical and biomechanical mechanisms of subacromial impingement syndrome. Clin Biomech (Bristol). 2003 Jun;18(5):369-79. doi: 10.1016/s0268-0033(03)00047-0.'}, {'pmid': '22802986', 'type': 'BACKGROUND', 'citation': 'Umer M, Qadir I, Azam M. Subacromial impingement syndrome. Orthop Rev (Pavia). 2012 May 9;4(2):e18. doi: 10.4081/or.2012.e18. Epub 2012 May 31.'}, {'pmid': '26537804', 'type': 'BACKGROUND', 'citation': 'Cools AM, Johansson FR, Borms D, Maenhout A. Prevention of shoulder injuries in overhead athletes: a science-based approach. Braz J Phys Ther. 2015 Sep-Oct;19(5):331-9. doi: 10.1590/bjpt-rbf.2014.0109. Epub 2015 Sep 1.'}, {'pmid': '16148361', 'type': 'BACKGROUND', 'citation': 'Lyons RP, Green A. Subscapularis tendon tears. J Am Acad Orthop Surg. 2005 Sep;13(5):353-63. doi: 10.5435/00124635-200509000-00009.'}, {'pmid': '29845083', 'type': 'BACKGROUND', 'citation': 'Johnson JE, Fullmer JA, Nielsen CM, Johnson JK, Moorman CT 3rd. Glenohumeral Internal Rotation Deficit and Injuries: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2018 May 22;6(5):2325967118773322. doi: 10.1177/2325967118773322. eCollection 2018 May.'}, {'pmid': '33062302', 'type': 'BACKGROUND', 'citation': 'Keramat KU, Naveed Babur M. Pragmatic posterior capsular stretch and its effects on shoulder joint range of motion. BMJ Open Sport Exerc Med. 2020 Sep 9;6(1):e000805. doi: 10.1136/bmjsem-2020-000805. eCollection 2020.'}, {'pmid': '18668168', 'type': 'BACKGROUND', 'citation': 'Laudner KG, Sipes RC, Wilson JT. The acute effects of sleeper stretches on shoulder range of motion. J Athl Train. 2008 Jul-Aug;43(4):359-63. doi: 10.4085/1062-6050-43.4.359.'}]}, 'descriptionModule': {'briefSummary': 'The glenohumeral joint is an articulation between the glenoid of the scapula and the head of the humerus that is enclosed by a synovial capsule divided into three main components: anterior, posterior, and the axillary pouch. Symptoms of posterior capsule tightness are linked to altered shoulder biomechanics and impairments which includes glenohumeral internal rotation deficit, incomplete glenohumeral adduction, impaired inferior glenohumeral ligament (IGHL) function, and increased risk of impingement symptoms. In the literature the two techniques available for stretching posterior capsule are pragmatic posterior capsular stretch and sleeper stretch. Pragmatic posterior capsular stretch is therapist administered and sleeper stretch is patient-administered. The work on the pragmatic posterior capsular stretch is more specified and rational to mark the tightness in the posterior capsule.', 'detailedDescription': 'Shoulder pathologies have been reported as the third most popular musculoskeletal problem after knee and back problems and are relatively common in 1 in 3 individuals in their lifetime and reported shoulder pain once a year. The Popular shoulder complex disorders are tendinopathies, rotator cuff lesions, serratus anterior paralysis, subacromial impingement syndrome, and adhesive capsulitis among these 44-65 percent shoulder disorders, contributing to subacromial impingement syndrome.\n\nPosterior capsular tightness is more common in overhead activities which increases the force on shoulder joint which may cause posterior capsular tightness along with rotator cuff tear. The active stabilizer for shoulder is rotator cuff which avoid the superior translation of humeral head during shoulder abduction due to weakness of rotator cuff along with posterior inferior capsular tightness the humeral head may translate superiorly and ultimately lead to SAIS in which rotator cuff tendon long head of biceps and subacromial bursa impinge between acromion superiorly and greater tubercle of humeral head inferiorly. Tears of the subscapularis tendon are mostly the result of a degenerative process, but less commonly, traumatic injury can result in acute subscapularis tearing. The most common mechanisms of subscapularis injury are hyperextension and external rotation of the shoulder.6 The infraspinatus (ISP) muscle, one of the rotator cuff muscles. Pain in the infraspinatus is most likely caused by repetitive motion involving the shoulder. Swimmers, tennis players, painters, and carpenters get it more frequently. It also becomes more likely as you get older.\n\nThe serratus anterior play an important role in prevention of shoulder impingement by lifting the acromion process in overhead activities. The most common pathologies of serratus anterior is serratus anterior dysfunction which may cause scapula winging.8 In GHIRD glenohumeral internal rotation deficit there is 18 to 20 degree of limitation along with glenohumeral horizontal adduction and incomplete humeral rotation can lead to posterior capsular tightness. Therefore, posterior capsular stretch is more effective intervention for posterior capsular tightness.AC joint is responsible for shoulder disability and pain in inactive patient and athletic activities including skiing, cycling and mostly in contact sports which contribute 9 percent approximately of AC joint damage with shoulder injuries. Impairment of AC joint effects range of motion, pain and weakness along with poor posture and these leads to restriction in overhead activities.\n\nThe most frequent causes are posterior capsular tightness and rotator cuff tear involve overhead movements such as swimming and volleyball and basketball, which have high-velocity pressures on the joint shoulder.\n\nIn non-operative management of subacromial impingement, anti-inflammatory mediction,subacromial injection of steriods, ultrasound, lifestyle changes, and physical therapy management is normally given. Physical therapy is used to reduce the pain and enhance the functioning of the SIS. Patients should attempt to discontinue overhead movements unless symptoms diminish.\n\nA pragmatic posterior capsular stretch (PPCS) is designed to stretch the posterior capsule when it is in torsion.Pragmatic Posterior capsular stretch can effectively improve the functional movements and shoulder ROM of healthy young adults.16 Another popular stretch is the "sleeper stretch". There is a significant increase in posterior shoulder flexibility by sleeper stretch.Scapular movement is restricted while performing the sleeper stretch and accomplished by lying on the side to be stretched, elevating the humerus to 90° on the support surface, then passively internally rotating the shoulder with the opposite arm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Limitation in range of motion abduction or internal rotation or external rotation or reaching up behind the back or reaching behind down the neck are only one of the limitations in comparison with the unaffected joint.\n\nA patient who fall in grade 1 and grade 2 of the shoulder mobility test of functional movement screening.\n\nExclusion Criteria:\n\n-Patient with shoulder ligamentous instability Functional movement Screening score 0 or 3. Cancerous growth around the shoulder girdle Rheumatoid arthritis patients The patient has a recent fracture of less than the 6th-week duration or shoulder dislocation.\n\nLong term use of steroids Cervical joint dysfunction, radicular pain. Systemic diseases.'}, 'identificationModule': {'nctId': 'NCT05064033', 'briefTitle': 'Pragmatic Posterior Capsular Stretch Versus Sleeper Stretch in Subject With Shoulder Pathologies', 'organization': {'class': 'OTHER', 'fullName': 'Helping Hand Institute of Rehabilitation Sciences'}, 'officialTitle': 'Pragmatic Posterior Capsular Stretch Versus Sleeper Stretch in Subject With Shoulder Pathologies: a Randomized Control Trial (RCT)', 'orgStudyIdInfo': {'id': 'Rec.letter/st./2021/20/03/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GROUP A', 'description': 'Pragmatic Set of intervention and posterior capsular stretch', 'interventionNames': ['Other: Pragmatic Set of intervention and posterior capsular stretch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP B', 'description': 'Pragmatic Set of intervention and Sleeper Stretch', 'interventionNames': ['Other: Pragmatic Set of intervention and Sleeper Stretch']}], 'interventions': [{'name': 'Pragmatic Set of intervention and posterior capsular stretch', 'type': 'OTHER', 'description': 'Group 1 will receive a pragmatic set of interventions, including Serratus Anterior Stretch,Rotator Cuff Facilitation,Acromilcalavicular joint Mobilization,Stretch of Pectoralis Major and Minor,Thoracic Manipulation and posterior capsular stretch.', 'armGroupLabels': ['GROUP A']}, {'name': 'Pragmatic Set of intervention and Sleeper Stretch', 'type': 'OTHER', 'description': 'Group 2 will receive a pragmatic set of interventions, including Serratus Anterior Stretch, Rotator Cuff Facilitation, Acromilcalavicular joint Mobilization, Stretch of Pectoralis Major and Minor, Thoracic Manipulation and sleeper stretch.', 'armGroupLabels': ['GROUP B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '213000', 'city': 'Mansehra', 'state': 'Khyber Pakhtunkhwa', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'keramat ullah keramat, Ph.D*', 'role': 'CONTACT', 'email': 'karamatjee@yahoo.com', 'phone': '+923330927670'}, {'name': 'Abdul Haseeb Bhutta, M.phil', 'role': 'CONTACT', 'email': 'abdul.haseeb@hhirs.edu.pk', 'phone': '+923479470947'}], 'facility': 'HHIRST', 'geoPoint': {'lat': 34.33023, 'lon': 73.19679}}], 'centralContacts': [{'name': 'keramat ullah karamat, Ph.D.*', 'role': 'CONTACT', 'email': 'karamatjee@yahoo.com', 'phone': '+923330927670'}, {'name': 'Abdul Haseeb Bhutta, M.Phil', 'role': 'CONTACT', 'email': 'abdul.haseeb@hhirs.edu.pk', 'phone': '+923479470947'}], 'overallOfficials': [{'name': 'keramat ullah karamat, Ph.D.*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HHIRST'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'As per the decision of the research ethics committee.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helping Hand Institute of Rehabilitation Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal HHIRS', 'investigatorFullName': 'Keramat Ullah', 'investigatorAffiliation': 'Helping Hand Institute of Rehabilitation Sciences'}}}}