- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04777370
Combined Effects of Manual Therapy on the Shoulder
July 6, 2021 updated by: University of Hartford
Are There Differences in Range of Motion, Glenohumeral Translation, and Rotator Cuff Activity Following Shoulder Mobilization, Stretching, or Thoracic Manipulation?
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
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West Hartford, Connecticut, United States, 06117
- University of Hartford
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: sleeper stretch + thoracic manipulation
The group will receive the sleeper stretch at session #1, and a thoracic manipulation followed by the sleeper stretch at session #2.
|
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.
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.
|
EXPERIMENTAL: posterior glenohumeral (PG) mobilization + thoracic manipulation
The group will receive a posterior glide mobilization at session #1, and a thoracic manipulation followed by posterior glide mobilization at session #2.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in shoulder IR ROM
Time Frame: Pre intervention to immediate (within 5 minutes) post intervention
|
Shoulder IR ROM measured with a goniometer
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Pre intervention to immediate (within 5 minutes) post intervention
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Change in posterior shoulder translation (mm)
Time Frame: Pre intervention to immediate (within 5 minutes) post intervention
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maximum posterior translation of the humeral head assessed with ultrasound imaging (mm)
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Pre intervention to immediate (within 5 minutes) post intervention
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Change in infraspinatus electromyographic activity (%MVIC)
Time Frame: Pre intervention to immediate (within 5 minutes) post intervention
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 31, 2021
Primary Completion (ACTUAL)
June 30, 2021
Study Completion (ACTUAL)
June 30, 2021
Study Registration Dates
First Submitted
February 22, 2021
First Submitted That Met QC Criteria
February 25, 2021
First Posted (ACTUAL)
March 2, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 7, 2021
Last Update Submitted That Met QC Criteria
July 6, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO2021000105
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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