Trial Outcomes & Findings for Changes in Subjects With Posterior Capsule Tightness (NCT NCT02353442)
NCT ID: NCT02353442
Last Updated: 2017-03-21
Results Overview
It was assessed in degrees with 3D system pre and post treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Results posted on
2017-03-21
Participant Flow
The participation of all subjects was voluntary and no incentives were given to encourage enrollment. Fliers posted in the local university setting and surrounding community were used to recruit individuals from March 2015 to March 2016.
Participant milestones
| Measure |
Control Group
This group will perform during 4 weeks:
* placebo ultrasound during 5min ;
* scapular squeezing in the sitting position (3x10repetitions);
* upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
Experimental Group
This group will perform during 4 weeks:
* posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
* external rotators strengthening in sidelying positions with load (3x10repetitions);
* posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
31
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Control Group
This group will perform during 4 weeks:
* placebo ultrasound during 5min ;
* scapular squeezing in the sitting position (3x10repetitions);
* upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
Experimental Group
This group will perform during 4 weeks:
* posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
* external rotators strengthening in sidelying positions with load (3x10repetitions);
* posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
Baseline Characteristics
Changes in Subjects With Posterior Capsule Tightness
Baseline characteristics by cohort
| Measure |
Control Group
n=28 Participants
This group will perform during 4 weeks:
* placebo ultrasound during 5min ;
* scapular squeezing in the sitting position (3x10repetitions);
* upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
Experimental Group
n=31 Participants
This group will perform during 4 weeks:
* posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
* external rotators strengthening in sidelying positions with load (3x10repetitions);
* posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.08 years
STANDARD_DEVIATION 12.08 • n=5 Participants
|
41.18 years
STANDARD_DEVIATION 12.84 • n=7 Participants
|
40.63 years
STANDARD_DEVIATION 12.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
59 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)It was assessed in degrees with 3D system pre and post treatment.
Outcome measures
| Measure |
Control Group
n=25 Participants
This group will perform during 4 weeks:
* placebo ultrasound during 5min ;
* scapular squeezing in the sitting position (3x10repetitions);
* upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
Experimental Group
n=27 Participants
This group will perform during 4 weeks:
* posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
* external rotators strengthening in sidelying positions with load (3x10repetitions);
* posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
|---|---|---|
|
Scapular Kinematics at 4weeks (Pre and Post Treatment)
Pre Internal Rotation
|
34.58 degrees
Standard Error 0.69
|
36.00 degrees
Standard Error 0.68
|
|
Scapular Kinematics at 4weeks (Pre and Post Treatment)
Post Internal Rotation
|
34.76 degrees
Standard Error 0.79
|
35.72 degrees
Standard Error 0.77
|
|
Scapular Kinematics at 4weeks (Pre and Post Treatment)
Pre Upward Rotation
|
-18.12 degrees
Standard Error 0.68
|
-16.47 degrees
Standard Error 0.66
|
|
Scapular Kinematics at 4weeks (Pre and Post Treatment)
Post Upward Rotation
|
-17.85 degrees
Standard Error 0.58
|
-14.37 degrees
Standard Error 0.57
|
|
Scapular Kinematics at 4weeks (Pre and Post Treatment)
Pre Posterior Tilt
|
-3.23 degrees
Standard Error 0.59
|
-2.41 degrees
Standard Error 0.58
|
|
Scapular Kinematics at 4weeks (Pre and Post Treatment)
Post Posterior Tilt
|
-3.66 degrees
Standard Error 0.60
|
-2.27 degrees
Standard Error 0.59
|
PRIMARY outcome
Timeframe: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)It was assessed in millimeters with 3D system pre and post treatment.
Outcome measures
| Measure |
Control Group
n=25 Participants
This group will perform during 4 weeks:
* placebo ultrasound during 5min ;
* scapular squeezing in the sitting position (3x10repetitions);
* upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
Experimental Group
n=27 Participants
This group will perform during 4 weeks:
* posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
* external rotators strengthening in sidelying positions with load (3x10repetitions);
* posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
|---|---|---|
|
Humeral Translations at 4weeks (Pre and Post Treatment).
Pre Anterior Translation
|
1.22 Millimeters
Standard Error 0.36
|
0.85 Millimeters
Standard Error 0.35
|
|
Humeral Translations at 4weeks (Pre and Post Treatment).
Post Anterior Translation
|
0.68 Millimeters
Standard Error 0.32
|
0.96 Millimeters
Standard Error 0.32
|
|
Humeral Translations at 4weeks (Pre and Post Treatment).
Pre Superior Translation
|
1.38 Millimeters
Standard Error 0.28
|
1.21 Millimeters
Standard Error 0.27
|
|
Humeral Translations at 4weeks (Pre and Post Treatment).
Post Superior Translation
|
1.12 Millimeters
Standard Error 0.22
|
0.66 Millimeters
Standard Error 0.22
|
SECONDARY outcome
Timeframe: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)The strength was evaluated with digital dynamometer in Newton pre and post treatment.
Outcome measures
| Measure |
Control Group
n=25 Participants
This group will perform during 4 weeks:
* placebo ultrasound during 5min ;
* scapular squeezing in the sitting position (3x10repetitions);
* upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
Experimental Group
n=27 Participants
This group will perform during 4 weeks:
* posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
* external rotators strengthening in sidelying positions with load (3x10repetitions);
* posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
|---|---|---|
|
Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).
Pre External rotators strength
|
89.08 Newton
Standard Deviation 32.86
|
90.96 Newton
Standard Deviation 28.71
|
|
Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).
Post External rotators strength
|
88.98 Newton
Standard Deviation 34.73
|
94.71 Newton
Standard Deviation 27.59
|
SECONDARY outcome
Timeframe: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)It was measured by a digital algometer in kPa pre and post treatment.
Outcome measures
| Measure |
Control Group
n=25 Participants
This group will perform during 4 weeks:
* placebo ultrasound during 5min ;
* scapular squeezing in the sitting position (3x10repetitions);
* upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
Experimental Group
n=27 Participants
This group will perform during 4 weeks:
* posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
* external rotators strengthening in sidelying positions with load (3x10repetitions);
* posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
|---|---|---|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Pre Upper Trapezius
|
287.40 kPa
Standard Deviation 90.52
|
312.12 kPa
Standard Deviation 135.02
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Post Upper Trapezius
|
351.47 kPa
Standard Deviation 174.59
|
355.82 kPa
Standard Deviation 161.77
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Pre Infraspinatus
|
351.33 kPa
Standard Deviation 129.94
|
409.46 kPa
Standard Deviation 198.58
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Post Infraspinatus
|
403.25 kPa
Standard Deviation 211.70
|
438.51 kPa
Standard Deviation 189.71
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Pre Supraspinatus
|
259.15 kPa
Standard Deviation 86.68
|
321.07 kPa
Standard Deviation 133.72
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Post Supraspinatus
|
343.88 kPa
Standard Deviation 159.75
|
353.40 kPa
Standard Deviation 161.16
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Pre Deltoid
|
301.78 kPa
Standard Deviation 92.58
|
310.90 kPa
Standard Deviation 147.84
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Post Deltoid
|
338.00 kPa
Standard Deviation 149.94
|
344.56 kPa
Standard Deviation 143.10
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Pre Levator Scapulae
|
256.63 kPa
Standard Deviation 85.43
|
261.14 kPa
Standard Deviation 125.89
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Post Levator Scapulae
|
267.26 kPa
Standard Deviation 108.97
|
269.25 kPa
Standard Deviation 109.36
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Pre Anterior Tibialis
|
711.31 kPa
Standard Deviation 227.74
|
676.57 kPa
Standard Deviation 270.60
|
|
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Post Anterior Tibialis
|
714.12 kPa
Standard Deviation 272.46
|
748.09 kPa
Standard Deviation 256.98
|
SECONDARY outcome
Timeframe: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)For these measures, the SPADI (Shoulder Pain and Disabilities Index) questionnaire was used, pre and post treatment. The is a self-assessment questionnaire with 5 questions about pain and 8 about functional activities. The final score (0-100) of the questionnaire is provided in percentage and a maximum score of 100 implies the worst possible condition.
Outcome measures
| Measure |
Control Group
n=25 Participants
This group will perform during 4 weeks:
* placebo ultrasound during 5min ;
* scapular squeezing in the sitting position (3x10repetitions);
* upper trapezius stretching (in sitting position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
Experimental Group
n=27 Participants
This group will perform during 4 weeks:
* posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);
* external rotators strengthening in sidelying positions with load (3x10repetitions);
* posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).
Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group.
|
|---|---|---|
|
Pain and Function at 4weeks (Pre and Post Treatment)
Pre SPADI score
|
46.01 scores on a scale
Standard Deviation 24.11
|
45.26 scores on a scale
Standard Deviation 23.22
|
|
Pain and Function at 4weeks (Pre and Post Treatment)
Post SPADI score
|
27.10 scores on a scale
Standard Deviation 23.75
|
17.22 scores on a scale
Standard Deviation 15.04
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place