- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02172079
Mobilization With Movement for Shoulder Impingement
June 23, 2014 updated by: César Fernández-de-las-Peñas
Effects of Mobilization-with-Movement on Pain and Range of Motion in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial
Controversy exists regarding the effectiveness of manual therapy techniques for the management of impingement syndrome.
However, no adequately powered clinical trials have examined the effects of mobilization-with-movement.
The purpose of the current study was to perform a randomized controlled trial comparing the effects of real MWM to a group receiving a sham intervention on shoulder pain at different moments and active shoulder range of motion in an adequately powered sample of patients with shoulder impingement syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
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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Salamanca, Spain, 37008
- Francisco Alburquerque Sendín
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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 > 3months duration
- pain localized at the proximal anterolateral shoulder region
- medical diagnosis of shoulder impingement syndrome
- at least 2 positive impingement tests including Neer, Hawking, or Jobe test
Exclusion Criteria:
- diagnosis of fibromyalgia
- pregnancy
- a history of traumatic onset of shoulder pain
- other histories of shoulder injury
- ligamentous laxity based on a positive Sulcus test and apprehension test
- numbness or tingling in the upper extremity
- previous shoulder or cervical spine surgery
- corticosteroid injection on the shoulder within 1 year of the study
- physical therapy 6 months prior to the study
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: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Real mobilization-with-movement (MWM)
For the MWM group, an accessory posterior-lateral gliding movement in the humeral head combined with a movement of active shoulder flexion will be applied.
One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior aspect of the head of the humerus
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Sham Comparator: Sham mobilization-with-movement (MWM)
The sham condition will replicate the treatment condition except for the hand positioning.
The therapist locates one hand over the belly of the pectoralis major muscle and the other over scapula without applying any pressure.
The patient will be asked to move the arm in a similar manner as in the MWM group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in the intensity of shoulder pain before and after the treatment
Time Frame: Baseline and one week after intervention
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Participants were asked to rate the intensity of their pain using an 11-point numerical pain rating scale (NPRS; 0: no pain; 10: maximum pain) for 3 scores of perceived pain: 1, the intensity of shoulder pain experienced in the last 24h; 2, the intensity of shoulder pain at night; 3, the intensity of shoulder pain during shoulder flexion.
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Baseline and one week after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in shoulder range of motion before and after the treatment
Time Frame: Baseline and one week after the intervention
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A universal goniometer was used to assess the participant's shoulder range of motion in the following motions:
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Baseline and one week after the intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Francisco Alburquerque Sendín, PT, PhD, University of Salamanca
- Study Chair: César Fernández de las Peñas, PT, PhD, Universidad Rey Juan 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
January 1, 2013
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
June 22, 2014
First Submitted That Met QC Criteria
June 23, 2014
First Posted (Estimate)
June 24, 2014
Study Record Updates
Last Update Posted (Estimate)
June 24, 2014
Last Update Submitted That Met QC Criteria
June 23, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- USAL201000048540
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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