Back to resultsCombined Effects of Manual Therapy on the Shoulder
Primary Purpose
Range of Motion, Manual Therapies, Shoulder Joint Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
posterior glide mobilization
Sleeper stretch
thoracic manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Range of Motion focused on measuring shoulder, Glenohumeral Internal Rotation Deficit (GIRD), joint play, muscular activity
Eligibility Criteria
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.
Sites / Locations
- University of Hartford
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
sleeper stretch + thoracic manipulation
posterior glenohumeral (PG) mobilization + thoracic manipulation
Arm Description
The group will receive the sleeper stretch at session #1, and a thoracic manipulation followed by the sleeper stretch at session #2.
The group will receive a posterior glide mobilization at session #1, and a thoracic manipulation followed by posterior glide mobilization at session #2.
Outcomes
Primary Outcome Measures
Change in shoulder IR ROM
Shoulder IR ROM measured with a goniometer
Change in posterior shoulder translation (mm)
maximum posterior translation of the humeral head assessed with ultrasound imaging (mm)
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04777370
Brief Title
Combined Effects of Manual Therapy on the Shoulder
Official Title
Are There Differences in Range of Motion, Glenohumeral Translation, and Rotator Cuff Activity Following Shoulder Mobilization, Stretching, or Thoracic Manipulation?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hartford
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Range of Motion, Manual Therapies, Shoulder Joint Disorder
Keywords
shoulder, Glenohumeral Internal Rotation Deficit (GIRD), joint play, muscular activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
All participants will undergo a single intervention during the first session, and then combined thoracic manipulation and a repeat of the prior intervention at the second session.
Masking
Outcomes Assessor
Masking Description
Assessment of electromyographic (EMG) activity, IR ROM pre-post intervention, and glenohumeral translation via ultrasound will be performed by a blinded assessor.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sleeper stretch + thoracic manipulation
Arm Type
Experimental
Arm Description
The group will receive the sleeper stretch at session #1, and a thoracic manipulation followed by the sleeper stretch at session #2.
Arm Title
posterior glenohumeral (PG) mobilization + thoracic manipulation
Arm Type
Experimental
Arm Description
The group will receive a posterior glide mobilization at session #1, and a thoracic manipulation followed by posterior glide mobilization at session #2.
Intervention Type
Other
Intervention Name(s)
posterior glide mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sleeper stretch
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
thoracic manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in shoulder IR ROM
Description
Shoulder IR ROM measured with a goniometer
Time Frame
Pre intervention to immediate (within 5 minutes) post intervention
Title
Change in posterior shoulder translation (mm)
Description
maximum posterior translation of the humeral head assessed with ultrasound imaging (mm)
Time Frame
Pre intervention to immediate (within 5 minutes) post intervention
Title
Change in infraspinatus electromyographic activity (%MVIC)
Description
activity of the infraspinatus muscle during posterior translation, assessed as a percentage of the maximal voluntary isometric contraction (MVIC)
Time Frame
Pre intervention to immediate (within 5 minutes) post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Swanson, PT, DSc
Organizational Affiliation
University of Hartford
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hartford
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combined Effects of Manual Therapy on the Shoulder
We'll reach out to this number within 24 hrs