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Trial record 67 of 79996 for:    subjects

Effects of a Pectoralis Minor Muscle Stretching Protocol (PMISP)

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ClinicalTrials.gov Identifier: NCT01956240
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : February 12, 2015
Last Update Posted : May 19, 2015
Sponsor:
Collaborator:
Universidade Metodista de Piracicaba
Information provided by (Responsible Party):
Dayana Patricia Rosa, Universidade Federal de Sao Carlos

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Procedure: Stretching-Asymptomatic subjects Procedure: Stretching-Subjects with shoulder pain Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : January 2014

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.
Procedure: 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.

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.
Procedure: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Asymptomatic subjects were included if they did not have any positive test for SIS.

The subjects with shoulder pain were included if:

  1. they had history of shoulder, at least one week;
  2. 18 - 45 years;
  3. range of motion > 150° evaluated with digital inclinometer;
  4. 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;
  5. Individuals from both groups also had to present with shortened PM muscle length.

Exclusion Criteria:

Individuals from both groups were excluded if they:

  1. BMI (body mass index) > 28kg/m2;
  2. irradiated shoulder pain;
  3. scoliosis;
  4. history of shoulder pain with beginning traumatic;
  5. history of fracture or surgery in upper limb and rotator cuff;
  6. systemic illnesses;
  7. tape allergy;
  8. were pregnant;
  9. physiotherapy at least 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956240


Locations
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Brazil
UFSCar
São Carlos, São Paulo, Brazil, 13565-905
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Universidade Metodista de Piracicaba
Investigators
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Principal Investigator: Dayana Rosa, PT UNIMEP

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Responsible Party: Dayana Patricia Rosa, Universidade Federal de São Carlos, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01956240     History of Changes
Other Study ID Numbers: 100/12
First Posted: October 8, 2013    Key Record Dates
Results First Posted: February 12, 2015
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by Dayana Patricia Rosa, Universidade Federal de Sao Carlos:
shoulder
pectoralis minor
stretching
scapular kinematics

Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms