- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01956240
Effects of a Pectoralis Minor Muscle Stretching Protocol (PMISP)
May 17, 2015 updated by: Dayana Patricia Rosa, Universidade Federal de Sao Carlos
Phase 4 Effects of a Stretching Protocol for the Pectoralis Minor Muscle on This Resting Length and on the 3D Kinematics of the Scapula During Arm Flexion in Asymptomatic Subjects and Patients With Impingement Syndrome
The purpose of this study is to verify the effects of a stretching protocol for the pectoralis minor muscle on its resting length and on the 3D kinematics of the scapula during arm flexion in asymptomatic subjects and patients with impingement syndrome with shortened pectoralis minor.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Fifty subjects (25 symptomatic and 25 asymptomatic for shoulder pain) will be recruited.
All of them will be initially assessed twice with one week between the assessments.
On each day, they will complete two questionnaires (DASH and SPADI) to assess pain and shoulder function.
The resting length of the pectoralis minor muscle and scapular kinematics data during arm flexion will also be measured using an electromagnetic tracking system.
Initially, the resting length of the pectoralis minor will be measured, and then 3 repetitions of arm elevation in the sagittal plane will be completed.
The stretching protocol will be performed daily for 6 weeks.
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface.
The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder.
This procedure will be done 4 times for 1 min and 30s interval between repetitions.
After the 6 weeks, the subject will have the same variables from the initial assessments reassessed.
For the questionnaires and length of pectoralis minor a two-way ANOVA for repeated measures will be used to check the main effects of group and evaluation and whether there is interaction between them.
For scapular internal/external rotation, upward/downward rotation, and tilt anterior/posterior a three-way ANOVA for repeated measures will use to analyze the main effects of group (symptomatic and asymptomatic), elevation angle of the arm (30°, 60°, 90° and 120°) and evaluation (1, 2 and 3) and whether there is evaluation x group x angle interaction.
A p value less than 0.05 will be considered significant.
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Phase 4
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
-
-
São Paulo
-
São Carlos, São Paulo, Brazil, 13565-905
- Ufscar
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Asymptomatic subjects were included if they did not have any positive test for SIS.
The subjects with shoulder pain were included if:
- they had history of shoulder, at least one week;
- 18 - 45 years;
- range of motion > 150° evaluated with digital inclinometer;
- one or more impingement tests positive - Neer (Neer, 1972), Hawkins (Hawkins and Kennedy, 1980) and Jobe (Jobe and Moynes, 1982) - associated with painful arc during arm elevation, or during external rotation with 90° of arm elevation;
- Individuals from both groups also had to present with shortened PM muscle length.
Exclusion Criteria:
Individuals from both groups were excluded if they:
- BMI (body mass index) > 28kg/m2;
- irradiated shoulder pain;
- scoliosis;
- history of shoulder pain with beginning traumatic;
- history of fracture or surgery in upper limb and rotator cuff;
- systemic illnesses;
- tape allergy;
- were pregnant;
- physiotherapy at least 6 months.
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stretching-Asymptomatic subjects
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface.
The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder.
This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface.
The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder.
This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
|
Experimental: Stretching-Subjects with shoulder pain
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface.
The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder.
This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface.
The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder.
This procedure will be done 4 times for 1 min and 30s interval between repetitions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pectoralis Minor Length After Pectoralis Minor Stretching Protocol
Time Frame: 6 weeks after stretching
|
The change of the pectoralis minor muscle will be evaluated with a tape measure and electromagnetic device.
The length of the muscle will be recorded in centimeters.
|
6 weeks after stretching
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Scapular Kinematics After Pectoralis Minor Stretching Protocol
Time Frame: 6 weeks of stretching
|
The scapular kinematics will be evaluated with electromagnetic device.
The changes in the scapular kinematics will be described in degrees.
|
6 weeks of stretching
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dayana Rosa, PT, UNIMEP
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
June 1, 2013
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
September 21, 2013
First Submitted That Met QC Criteria
October 4, 2013
First Posted (Estimate)
October 8, 2013
Study Record Updates
Last Update Posted (Estimate)
May 19, 2015
Last Update Submitted That Met QC Criteria
May 17, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100/12
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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