Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:11 PM
Study NCT ID:
NCT06447493
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2024-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Spencer's Technique on Shoulder Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C092779', 'term': 'RE1-silencing transcription factor'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Two by Two cross-over trial. Measurements will be taken on both shoulders with only the dominant shoulder receiving osteopathic manipulative treatment (OMT). The order in which the measurements and OMT treatment is performed will be randomized. The cross-over design allows for the opportunity to estimate 3 components, the possible effect of ultrasound measurement on the outcomes even when OMT is not performed, the combined effect of OMT and ultrasound measurements on outcomes, and an adjusted estimate OMT treatment effect removing any ultrasound effects if those effects exist. Change scores for all outcomes will be calculated per shoulder and then a comparison between change scores will be conducted using a paired design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Stiffness', 'timeFrame': 'Day 1 Pre, Day 1 Post, Day 2', 'description': 'Using Shear Wave Elastography to measure muscle stiffness (kPa) of the supraspinatus, infraspinatus, posterior shoulder capsule, and coracoacromial ligament.'}, {'measure': 'Shoulder Mobility', 'timeFrame': 'Day 1 Pre, Day 1 Post, Day 2', 'description': 'Using Vicon motion capture system to calculate landmark coordinates and using morphometric canonical variate analysis to analyze mobility changes.'}, {'measure': 'Microvascular/capillary blood flow', 'timeFrame': 'Day 1 Pre, Day 1 Post, Day 2', 'description': 'Using ultrasound to capture blood flow of the supraspinatus, infraspinatus, posterior shoulder capsule, and coracoacromial ligament.'}, {'measure': 'Subjective Shoulder Stiffness (Visual Analogue Scale)', 'timeFrame': 'Day 1 Pre, Day 2', 'description': 'Using Visual Analogue scale to measure participant\'s subjective measure of shoulder stiffness. Scores range from 0 to 10, with 0 being "Not stiff at all" and 10 being "Very stiff."'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteopathic Physicians', 'Shoulder', 'Diagnostic Imaging', 'Motion Capture', 'Range of Motion, Articular', 'Blood Circulation', 'Pain'], 'conditions': ['Shoulder']}, 'referencesModule': {'references': [{'pmid': '12138953', 'type': 'BACKGROUND', 'citation': 'Knebl JA, Shores JH, Gamber RG, Gray WT, Herron KM. Improving functional ability in the elderly via the Spencer technique, an osteopathic manipulative treatment: a randomized, controlled trial. J Am Osteopath Assoc. 2002 Jul;102(7):387-96.'}, {'pmid': '33475581', 'type': 'BACKGROUND', 'citation': 'Iqbal M, Riaz H, Ghous M, Masood K. Comparison of Spencer muscle energy technique and Passive stretching in adhesive capsulitis: A single blind randomized control trial. J Pak Med Assoc. 2020 Dec;70(12(A)):2113-2118. doi: 10.5455/JPMA.23971.'}, {'type': 'BACKGROUND', 'citation': 'Haveela, B., Praveen Dowle, and P. Chandrasekhar.'}, {'pmid': '10717855', 'type': 'BACKGROUND', 'citation': 'Yamaguchi K, Sher JS, Andersen WK, Garretson R, Uribe JW, Hechtman K, Neviaser RJ. Glenohumeral motion in patients with rotator cuff tears: a comparison of asymptomatic and symptomatic shoulders. J Shoulder Elbow Surg. 2000 Jan-Feb;9(1):6-11. doi: 10.1016/s1058-2746(00)90002-8.'}, {'pmid': '31769543', 'type': 'BACKGROUND', 'citation': 'Kunz P, Mick P, Gross S, Schmidmaier G, Zeifang F, Weber MA, Fischer C. Contrast-Enhanced Ultrasound (CEUS) as Predictor for Early Retear and Functional Outcome After Supraspinatus Tendon Repair. J Orthop Res. 2020 May;38(5):1150-1158. doi: 10.1002/jor.24535. Epub 2019 Dec 2.'}, {'pmid': '16127127', 'type': 'BACKGROUND', 'citation': 'Matava MJ, Purcell DB, Rudzki JR. Partial-thickness rotator cuff tears. Am J Sports Med. 2005 Sep;33(9):1405-17. doi: 10.1177/0363546505280213.'}, {'pmid': '31246863', 'type': 'BACKGROUND', 'citation': 'Lawrence RL, Moutzouros V, Bey MJ. Asymptomatic Rotator Cuff Tears. JBJS Rev. 2019 Jun;7(6):e9. doi: 10.2106/JBJS.RVW.18.00149.'}, {'pmid': '8321574', 'type': 'BACKGROUND', 'citation': 'Coren S. Measurement of handedness via self-report: the relationship between brief and extended inventories. Percept Mot Skills. 1993 Jun;76(3 Pt 1):1035-42. doi: 10.2466/pms.1993.76.3.1035.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to see the impact of a modified Spencer's technique on tissue stiffness, mobility, and blood flow of the shoulder joint. Spencer's technique is a well-known osteopathic manipulative treatment (OMT) that is common for treating adhesive capsulitis and is believed to help blood flow. There are studies that look at the clinical effects of the technique and/or compare it to other techniques; however, measuring the extent to which Spencer's technique, or this modified technique, improves tissue stiffness and blood flow has never been written in the literature. This study will serve as a proof of concept that this technique improves tissue stiffness, blood flow, and mobility of the shoulder join as well as the nearby areas. Using ultrasound, the investigators will measure tissue stiffness and blood flow and will analyze the mobility of the shoulder joint using a Vicon motion capture system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• male and female subjects 18-50 years old\n\nExclusion Criteria:\n\n* prior shoulder surgery or injury to the reported dominant throwing arm\n* shoulder pain in the reported dominant throwing arm within the last 6 months\n* diagnosis cervical radiculopathy or pinched nerve in the neck\n* connective tissue or muscle disorders\n* known pregnancy\n* tobacco use\n* known diabetes or prediabetes\n* allergy to ultrasound gel (propylene glycol)'}, 'identificationModule': {'nctId': 'NCT06447493', 'briefTitle': "Effects of Spencer's Technique on Shoulder Function", 'organization': {'class': 'OTHER', 'fullName': 'Edward Via Virginia College of Osteopathic Medicine'}, 'officialTitle': "Exploring the Effects of Spencer's Technique on Shoulder Function: A Pilot Study", 'orgStudyIdInfo': {'id': '2023-061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OMT Intervention, then Rest', 'description': '10 subjects will be randomized to begin with the dominant shoulder. Investigators will measure baseline outcomes on the dominant shoulder, apply OMT treatment, measure post treatment outcomes on dominant shoulder, a 5-minute rest period as a washout period, then proceed to measure baseline measures on non-dominant shoulder, a rest that is equivalent to the time needed for OMT treatment, ending with post measurements on the non-dominant shoulder.', 'interventionNames': ["Other: Osteopathic Manipulative Treatment-Spencer's Technique (Modified)", 'Other: Rest']}, {'type': 'EXPERIMENTAL', 'label': 'Rest, then OMT Intervention', 'description': '10 subjects will be randomized to begin with the non-dominant shoulder. Investigators will measure baseline outcomes on the non-dominant shoulder, a rest period equivalent to the time needed for OMT treatment, measure post treatment outcomes on non-dominant shoulder, a 5-minute rest period as a washout period, then proceed to measure baseline measures on dominant shoulder, provide OMT treatment, ending with post measurements on the dominant shoulder.', 'interventionNames': ["Other: Osteopathic Manipulative Treatment-Spencer's Technique (Modified)", 'Other: Rest']}], 'interventions': [{'name': "Osteopathic Manipulative Treatment-Spencer's Technique (Modified)", 'type': 'OTHER', 'description': 'Combination OMT approach utilizing Muscle Energy Technique (MET), Articulatory Technique (ART), and Myofascial Release (MFR). It is a series of direct OMT addressing the barrier of somatic dysfunction (SD) with the goal of restoring neurovascular balance and improved motion of the shoulder girdle and glenohumeral joint. Utilizing these three OMT techniques, the practitioner attempts restoration of glenohumeral joint motion using shoulder extension, flexion, circumduction with compression, circumduction with distraction, abduction, adduction, external rotation, internal rotation, and distraction in abduction. The study uses a modified version of the Spencer technique, done in the seated position for patient comfort, as well as adding to the treatment sequence: latissimus dorsi, pectoralis minor-major, serratus anterior, and rhomboid major-minor. Adding these muscles into treatment will help to address and correct sternoclavicular joint SD, acromioclavicular joint SD, and scapular SD.', 'armGroupLabels': ['OMT Intervention, then Rest', 'Rest, then OMT Intervention']}, {'name': 'Rest', 'type': 'OTHER', 'description': '10 minute rest period.', 'armGroupLabels': ['OMT Intervention, then Rest', 'Rest, then OMT Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36832', 'city': 'Auburn', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Cawley, DC, MSHS, MS', 'role': 'CONTACT', 'email': 'dcawley@auburn.vcom.edu', 'phone': '334-442-4105'}], 'facility': 'Edward Via College of Osteopathic Medicine-Auburn', 'geoPoint': {'lat': 32.60986, 'lon': -85.48078}}], 'centralContacts': [{'name': 'Daniel Cawley, DC, MSHS, MS', 'role': 'CONTACT', 'email': 'dcawley@auburn.vcom.edu', 'phone': '334-442-4105'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edward Via Virginia College of Osteopathic Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Daniel Cawley', 'investigatorAffiliation': 'Edward Via Virginia College of Osteopathic Medicine'}}}}