- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02463526
Effects of Mulligan's Technique in Subjects With Shoulder Impingement Syndrome
December 20, 2015 updated by: João Flávio Guimarães, Universidade Federal de Sao Carlos
The Effects of Mulligan's Technique on Range of Movement, Pressure Pain Threshold, Muscle Strength, and Functionality in Subjects With Shoulder Impingement Syndrome
Participants will be initially assessed for their suitability for inclusion in the study and will undergo a physical screening of the affected shoulder and cervical spine by an experienced physiotherapist.
After, participants will be attended 72 hours after data recording of the baseline measures (range of motion with a goniometer, pressure pain threshold with a algometer, and peak force with a dynamometer) for four sessions per week with 24 hours of interval between sessions.
At each experimental week session, each participant will receive one of the two treatment conditions (MWM or sham) and then will repeats the assessment.
In the following week, there will be a crossover condition of each individual and 24 hours after the last treatment session, the examiner will do the last assessment.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
27
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
-
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São Paulo
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São Carlos, São Paulo, Brazil, CEP 13565-905
- UFSCar
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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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- history of shoulder pain of >1-week duration, localized at the proximal anterolateral shoulder region consistent to Shoulder Impingement Syndrome (SIS);
- at least 1 positive impingement test (Jobe's test, Neer's test, Hawkins-Kennedy's Test) associated with painful range of motion during arm elevation; or pain during external rotation with the arm in 90 degrees of elevation in the coronal plane.
Exclusion Criteria:
- fibromyalgia (based on self-report),pregnancy, a history of onset of symptoms because of traumatic injury, other histories of shoulder injury, torn tendons, ligamentous laxity based on positive Sulcus test and apprehension test, numbness or tingling in the upper extremity, previous shoulder or neck surgery, systemic illnesses, body mass index > 28kg/m2, corticosteroid injection 3 months before evaluation, physical therapy 3 months before evaluation.
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: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 - MWM condition/Sham condition
Subjects will receive treatment for 4 times with Mulligan's Mobilization with Movement (MWM) condition, and after 72 hrs, will be treated 4 times with the sham condition.
|
The treatment condition consists in the application of a posterolateral glide (MWM) in the affected shoulder.
Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder.
One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the humerus head anterior aspect.
A posterior glide will be applied to the humeral head.
Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set.
Sham condition will replicate treatment condition except for the hand positioning.
The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder.
A simulated anterior glide will be performed.
The Sham condition consists in the application of a simulated anterior glide in the affected shoulder.
Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder.
The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder.
A simulated anterior glide will be performed.
Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set.
The treatment condition will replicate treatment condition except for the hand positioning.
The therapist will place one hand over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior humerus head.
A posterior glide will be applied to the humeral head.
|
Experimental: Group 2 - Sham condition/MWM condition
Subjects will receive treatment for 4 times with sham condition, and after 72 hrs, will be treated 4 times with the Mulligan's Mobilization with Movement (MWM) condition.
|
The treatment condition consists in the application of a posterolateral glide (MWM) in the affected shoulder.
Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder.
One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the humerus head anterior aspect.
A posterior glide will be applied to the humeral head.
Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set.
Sham condition will replicate treatment condition except for the hand positioning.
The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder.
A simulated anterior glide will be performed.
The Sham condition consists in the application of a simulated anterior glide in the affected shoulder.
Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder.
The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder.
A simulated anterior glide will be performed.
Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set.
The treatment condition will replicate treatment condition except for the hand positioning.
The therapist will place one hand over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior humerus head.
A posterior glide will be applied to the humeral head.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure Pain Threshold
Time Frame: 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
|
The pressure pain threshold will be assessed with a algometer and the unit of measure is the kilogram per square centimeter.
|
72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of Motion
Time Frame: 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
|
The range of motion will be assessed with a goniometer and the unit of measure is the degree
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72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
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Peak Force
Time Frame: 72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
|
The Peak Force will be assessed with a handheld dynamometer and the unit of measure is the kilogram.
|
72 hours before the treatment starts, 24 hours after the last MWM or Shaw treatment, and 24 hours after the last treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Francisco Alburquerque-Sendín, Professor, Universidade Federal de Sao Carlos
- Study Chair: Tania Salvini, Professor, Universidade Federal de Sao Carlos
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
April 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
April 30, 2015
First Submitted That Met QC Criteria
June 1, 2015
First Posted (Estimate)
June 4, 2015
Study Record Updates
Last Update Posted (Estimate)
December 22, 2015
Last Update Submitted That Met QC Criteria
December 20, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1154-7379
- 28898014.3.0000.5504 (Other Identifier: Plataforma Brasil)
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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