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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04777370
Other study ID # PRO2021000105
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 31, 2021
Est. completion date June 30, 2021

Study information

Verified date July 2021
Source University of Hartford
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Interventions including glenohumeral mobilization, sleeper stretches, and thoracic manipulation have been proposed for individuals with loss of shoulder range of motion (ROM). However, the effect of these interventions on shoulder ROM, joint translation, and muscular activity have not been studied in combination.


Description:

Forty individuals with a loss of internal rotation (IR) ROM will be recruited and randomized to one of two interventions at the first session: either posterior glenohumeral mobilization or internal rotation "sleeper" stretching. At the second visit, all participants will undergo a thoracic manipulation (T3-4 segment) followed by a repeat of either the sleeper stretch or glenohumeral mobilization.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - loss of IR of 15 degrees of greater compared to contralateral shoulder Exclusion Criteria: - currently neck/upper back pain, - history of spinal fractures, - numbness/altered sensation of the arms or legs, - whiplash injury within the prior 6 weeks, - infections of the spine, - currently pregnant/possibly pregnant, - known osteoporosis, - Rheumatoid arthritis, - previous spine surgery, - currently receiving Workman's Compensation, - any pending litigation regarding a neck or shoulder injury, - history of oral corticosteroids in the prior 6 months, - history of shoulder fractures, - Current treatment for cancer, - Prior history of cancer involving the spine/shoulder, - any history of coagulation disorders. - Individuals with a history of shoulder surgery will reviewed on a case by case basis.

Study Design


Intervention

Other:
posterior glide mobilization
The participant will be positioned supine on a plinth, with their scapula stabilized against a firm wedge on the table, and the shoulder joint in the resting position (approx. 55 degrees abduction, 30 degrees horizontal adduction, and slight external rotation). With the extremity held in the same position, the researcher will then apply a grade III (into tissue stretch) PG mobilization. This will consist of five 30-second bouts of sustained gr III posterior glide mobilizations.
Sleeper stretch
All participants randomized to the stretching group will perform five 30-second holds of the sleeper stretch. This is performed by lying on the side to be stretched, elevating the upper arm to 90° on the support surface with the elbow bent 90°, then passively internally rotating the shoulder with force provided by with the opposite arm.
thoracic manipulation
Individuals will then undergo a single supine grade V thrust manipulation. All manipulations will take place at the T3-4 segment. If a cavitation ("pop") is not heard or felt by either the subject or examiner, a second thrust will be performed.

Locations

Country Name City State
United States University of Hartford West Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
University of Hartford

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in shoulder IR ROM Shoulder IR ROM measured with a goniometer Pre intervention to immediate (within 5 minutes) post intervention
Primary Change in posterior shoulder translation (mm) maximum posterior translation of the humeral head assessed with ultrasound imaging (mm) Pre intervention to immediate (within 5 minutes) post intervention
Primary Change in infraspinatus electromyographic activity (%MVIC) activity of the infraspinatus muscle during posterior translation, assessed as a percentage of the maximal voluntary isometric contraction (MVIC) Pre intervention to immediate (within 5 minutes) post intervention
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