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Effects of a Pectoralis Minor Muscle Stretching Protocol (PMISP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 21, 2013
First Posted Date  ICMJE October 8, 2013
Results First Submitted Date  ICMJE January 18, 2015
Results First Posted Date  ICMJE February 12, 2015
Last Update Posted Date May 19, 2015
Study Start Date  ICMJE June 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2013)
Length of the pectoralis minor 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.
Change History Complete list of historical versions of study NCT01956240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2015)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2013)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of a Pectoralis Minor Muscle Stretching Protocol
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Shoulder Pain
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Stretching-Asymptomatic subjects
  • 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.
    Intervention: Procedure: Stretching-Subjects with shoulder pain
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2015)
97
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2013)
50
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01956240
Other Study ID Numbers  ICMJE 100/12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dayana Patricia Rosa, Universidade Federal de Sao Carlos
Study Sponsor  ICMJE Universidade Federal de Sao Carlos
Collaborators  ICMJE Universidade Metodista de Piracicaba
Investigators  ICMJE
Principal Investigator: Dayana Rosa, PT UNIMEP
PRS Account Universidade Federal de Sao Carlos
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP