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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06447493
Other study ID # 2023-061
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2023
Est. completion date July 15, 2025

Study information

Verified date June 2024
Source Edward Via Virginia College of Osteopathic Medicine
Contact Daniel Cawley, DC, MSHS, MS
Phone 334-442-4105
Email dcawley@auburn.vcom.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date July 15, 2025
Est. primary completion date July 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: • male and female subjects 18-50 years old Exclusion Criteria: - prior shoulder surgery or injury to the reported dominant throwing arm - shoulder pain in the reported dominant throwing arm within the last 6 months - diagnosis cervical radiculopathy or pinched nerve in the neck - connective tissue or muscle disorders - known pregnancy - tobacco use - known diabetes or prediabetes - allergy to ultrasound gel (propylene glycol)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Osteopathic Manipulative Treatment-Spencer's Technique (Modified)
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.
Rest
10 minute rest period.

Locations

Country Name City State
United States Edward Via College of Osteopathic Medicine-Auburn Auburn Alabama

Sponsors (1)

Lead Sponsor Collaborator
Edward Via Virginia College of Osteopathic Medicine

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

Haveela, B., Praveen Dowle, and P. Chandrasekhar.

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Stiffness Using Shear Wave Elastography to measure muscle stiffness (kPa) of the supraspinatus, infraspinatus, posterior shoulder capsule, and coracoacromial ligament. Day 1 Pre, Day 1 Post, Day 2
Primary Shoulder Mobility Using Vicon motion capture system to calculate landmark coordinates and using morphometric canonical variate analysis to analyze mobility changes. Day 1 Pre, Day 1 Post, Day 2
Primary Microvascular/capillary blood flow Using ultrasound to capture blood flow of the supraspinatus, infraspinatus, posterior shoulder capsule, and coracoacromial ligament. Day 1 Pre, Day 1 Post, Day 2
Primary Subjective Shoulder Stiffness (Visual Analogue Scale) 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." Day 1 Pre, Day 2
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