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Effects of a Pectoralis Minor Muscle Stretching Protocol (PMISP)

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Stretching-Asymptomatic subjects
Stretching-Subjects with shoulder pain
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring shoulder, pectoralis minor, stretching, scapular kinematics

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UFSCar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stretching-Asymptomatic subjects

Stretching-Subjects with shoulder pain

Arm Description

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.

Outcomes

Primary Outcome Measures

Pectoralis Minor Length After Pectoralis Minor Stretching Protocol
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

Scapular Kinematics After Pectoralis Minor Stretching Protocol
The scapular kinematics will be evaluated with electromagnetic device. The changes in the scapular kinematics will be described in degrees.

Full Information

First Posted
September 21, 2013
Last Updated
May 17, 2015
Sponsor
Universidade Federal de Sao Carlos
Collaborators
Universidade Metodista de Piracicaba
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1. Study Identification

Unique Protocol Identification Number
NCT01956240
Brief Title
Effects of a Pectoralis Minor Muscle Stretching Protocol
Acronym
PMISP
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
Universidade Metodista de Piracicaba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
shoulder, pectoralis minor, stretching, scapular kinematics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stretching-Asymptomatic subjects
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching-Subjects with shoulder pain
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stretching-Asymptomatic subjects
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Stretching-Subjects with shoulder pain
Intervention Description
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 Measure Information:
Title
Pectoralis Minor Length After Pectoralis Minor Stretching Protocol
Description
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.
Time Frame
6 weeks after stretching
Secondary Outcome Measure Information:
Title
Scapular Kinematics After Pectoralis Minor Stretching Protocol
Description
The scapular kinematics will be evaluated with electromagnetic device. The changes in the scapular kinematics will be described in degrees.
Time Frame
6 weeks of stretching

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dayana Rosa, PT
Organizational Affiliation
UNIMEP
Official's Role
Principal Investigator
Facility Information:
Facility Name
UFSCar
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13565-905
Country
Brazil

12. IPD Sharing Statement

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Effects of a Pectoralis Minor Muscle Stretching Protocol

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