- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01639651
The Acute Effect of a Mobilization With Movement Technique to Improve Internal Rotation of the Shoulder
Principal Investigator
For many years researchers have been documented that the shoulder of the throwing athlete acquires a increase in external rotation of the dominant limb compared to the contralateral side.This fact is followed with a loss of the internal rotation of the shoulder, which is related with a higher rate of injuries in this joint and it´s known as Glenohumeral Internal Rotation Deficit (GIRD).
Among the approaches for this condition the literature is inconclusive due to the low methodological quality of clinical trials made,however, the manual therapy has been used with success to relief the pain and restore the range of motion.
The purpose of this study is to analyse the effectiveness of a mobilization with movement technique to improve the internal rotation of the shoulder in throwing athletes with GIRD.
It will be a randomized controlled trial with the CONSORT bases with 40 participants that will be divided into two groups:
- Control group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation)of both limbs, upper limb active movements to warm-up (five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) and revaluation immediately post-intervention and four weeks post-intervention.
- Mobilization group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation)of both limbs, upper limb active movements to warm-up(five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) plus a mobilization with movement technique to improve internal rotation of the dominant shoulder (three sets of 10 repetitions)and revaluation immediately post-intervention and four weeks post-intervention.
To evaluate the range of movement it will be use a standard goniometer with an attached customizes bubble inclinometer to ensure proper perpendicular alignment of the goniometer to the ground.
The investigators hypothesis is that both group will have improvements in the internal rotation of the dominant shoulder, however, the mobilization group will have a statistically significant difference compared to control group immediately post-intervention. Four weeks post-intervention this difference will equalize, because of the only intervention applied.
Results will be expressed as hazard ratios (HR) with their respective confidence intervals at 95% and adopting α = 0.05. All analyzes will be performed by SPSS version 17.0
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
-
São Paulo, Brazil, 04039-001
- Federal University of São Paulo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Athletes that practice at least 10 hours of throwing sports.
- Glenohumeral internal rotation deficits of the dominant shoulder compare to the non-dominant limb.
- Agree to participate and signing the informed consent approved for the Federal University of São Paulo ethics committee.
Exclusion Criteria:
- Previous surgeries of the shoulders.
- Unable to perform the evaluation or treatment due to pain.
- Performing physical therapy treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
|
Control group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation)for both limbs, upper limb active movements to warm-up (five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) and revaluation immediately post-intervention and four weeks post-intervention.
Other Names:
|
|
Experimental: Mobilization Group
|
Mobilization group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation) for both limbs, upper limb active movements to warm-up (five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) plus a mobilization with movement to improve internal rotation of the dominant shoulder (three sets of 10 repetitions)and revaluation immediately post-intervention and four weeks post-intervention.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Analyse the effectiveness of a mobilization with movement technique to improve internal rotation of the shoulder in throwers athletes with GIRD
Time Frame: Immediately post-intervention and four weeks post-intervention
|
The 40 patients will be divided in two groups of 20.
Both will perform a evaluation of the internal and external rotation of the shoulders to determine the individual internal rotation deficit of the dominant shoulder compared to the contralateral side.
One group (Control) will perform what the literature recommends (Stretch of the posterior capsule), and the other group (Mobilization) will add to the control intervention a mobilization with movement technique to improve the internal rotation deficit which was identified previously.
|
Immediately post-intervention and four weeks post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Renato R Soliaman, Centro de Traumatologia do Esporte - CETE
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02195112.7.0000.5505
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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