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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Shoulder Pain
Interventions Procedure: Stretching-Asymptomatic subjects
Procedure: Stretching-Subjects with shoulder pain
Enrollment 97
Recruitment Details Fliers posted in the local university setting and community were used to recruit symptomatic individuals, between february of 2012 and January of 2014. Asymptomatic individuals were recruited through personal contacts of the investigators.
Pre-assignment Details If participants did not come back to second evaluation, they were not assignments to groups.
Arm/Group Title Asymptomatic Subjects Subjects With Shoulder Pain
Hide Arm/Group 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.
Period Title: Overall Study
Started 48 49
Completed 25 25
Not Completed 23 24
Reason Not Completed
Lost to Follow-up             6             20
Adverse Event             17             4
Arm/Group Title Asymptomatic Subjects Subjects With Shoulder Pain Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 48 49 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 49 participants 97 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
48
 100.0%
49
 100.0%
97
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 49 participants 97 participants
Female
26
  54.2%
28
  57.1%
54
  55.7%
Male
22
  45.8%
21
  42.9%
43
  44.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 48 participants 49 participants 97 participants
48 49 97
1.Primary Outcome
Title Pectoralis Minor Length After Pectoralis Minor Stretching Protocol
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Asymptomatic Subjects Subjects With Shoulder Pain
Hide Arm/Group 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.
Overall Number of Participants Analyzed 48 49
Mean (Standard Deviation)
Unit of Measure: centimeters
16.38  (1.46) 16.87  (1.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asymptomatic Subjects, Subjects With Shoulder Pain
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments A 1-way repeated measures ANOVA was used to assess for possible differences among evaluations in each group separately for pectoralis minor length.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.51
Parameter Dispersion
Type: Standard Deviation
Value: 1.90
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Scapular Kinematics After Pectoralis Minor Stretching Protocol
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Asymptomatic Subjects Subjects With Shoulder Pain
Hide Arm/Group 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.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: degree
30  (5) 40  (5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asymptomatic Subjects, Subjects With Shoulder Pain
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments Separate 2-way repeated measures ANOVAs were used to test for interactions of angle x evaluation (1,2,3) and for main effects of evaluation.
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 5
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Asymptomatic Subjects Subjects With Shoulder Pain
Hide Arm/Group 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.
All-Cause Mortality
Asymptomatic Subjects Subjects With Shoulder Pain
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Asymptomatic Subjects Subjects With Shoulder Pain
Affected / at Risk (%) Affected / at Risk (%)
Total   23/48 (47.92%)   24/49 (48.98%) 
Social circumstances     
Desistance  [1]  23/48 (47.92%)  24/49 (48.98%) 
Indicates events were collected by systematic assessment
[1]
Forty seven participants left this study because personal reasons.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Asymptomatic Subjects Subjects With Shoulder Pain
Affected / at Risk (%) Affected / at Risk (%)
Total   15/48 (31.25%)   7/49 (14.29%) 
Musculoskeletal and connective tissue disorders     
No shortened pectoralis minor * [1]  15/48 (31.25%)  7/49 (14.29%) 
*
Indicates events were collected by non-systematic assessment
[1]
Fifteen participants did not present shortening of pectoralis minor.
  1. Participants may not have maximally elongated muscle;
  2. Linear measurements such as that used to quantify muscle length cannot represent real structural changes;
  3. Only chronic pain was evaluated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Ms Dayana Patricia Rosa
Organization: Methodist University of Piracicaba
Phone: +55 16 3306-6696
Responsible Party: Dayana Patricia Rosa, Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier: NCT01956240     History of Changes
Other Study ID Numbers: 100/12
First Submitted: September 21, 2013
First Posted: October 8, 2013
Results First Submitted: January 18, 2015
Results First Posted: February 12, 2015
Last Update Posted: May 19, 2015