CompletedNCT02353442Updated Mar 21, 2017Results posted

Changes in Subjects With Posterior Capsule Tightness

An interventional study of Posterior shoulder mobilizations and External rotators strengthening in Shoulder Pain, sponsored by Universidade Federal de Sao Carlos. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-03-21.

Sponsored by Universidade Federal de Sao Carlos · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 59
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

To identify biomechanical and sensibility changes in people with posterior capsule tightness in people with and without shoulder pain.

Read the detailed description

Some studies have shown that posterior capsule tightness can be related with shoulder dysfunctions and kinematics alterations. This study will be divided in two studies. The purpose of study 1 will be to assess the scapular and humeral kinematics, the strength of the shoulder external rotators and the pressure pain threshold in subjects with posterior capsule tightness with and without shoulder pain. Study 2 will verify the effects of two different treatments in subjects with posterior capsule tightness and shoulder pain on the same variables of study 1. One-hundred subjects will participate in the first study and will be divided in 4 groups: Group 1 - 25 subjects with shoulder pain and posterior capsule tightness; Group 2 - 25 subjects with no shoulder pain and no posterior capsule tightness; Group 3 - 25 subjects with shoulder pain and no posterior capsule tightness; and group 4 - 25 subjects with no shoulder pain and no posterior capsule tightness. All subjects will complete the DASH and Shoulder Pain and Disability Index questionnaires. External and internal rotation range of motion, strength of the external rotators, scapular kinematics and humeral translations during arm elevation, and pressure pain threshold will be measured. For the second study 50 subjects with shoulder pain and posterior capsule tightness will be recruited. The subjects will be randomly divided in 2 groups: experimental group or control group. The experimental group will receive glenohumeral posterior mobilization, stretching of posterior capsule and strengthening of the shoulder external rotators. The control group will do ultrasound;, stretching for the upper trapezius and scapular squeezing. Both groups will receive intervention for 3x/week/4 weeks. All subjects will be supervised for one physiotherapist and same variables from study 1 will be analyzed at pre and post-intervention.

Conditions studied

Shoulder Pain

Browse trials for

Shoulder Pain 707

Keywords

Pain
Rotator cuff
Stretching
Mobilization
Scapula
Posterior capsule

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 59 is close to the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Universidade Federal de Sao Carlos is the lead sponsor of 85 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria: all subjects should have posterior capsule tightness and shoulder pain. So they should have:

low flexion test (flexion + internal rotation) > 7°, between arms;
symptoms consistent to shoulder impingement and arm elevation close to 150° as determined by digital inclinometer. The diagnosis for SIS was made based on a clinical examination and self-reported history. To be classified as having shoulder impingement, subjects had to present with at least 3 of the following: positive Neer test, positive Hawkins test, positive Jobe test, pain with passive or isometric resisted shoulder lateral rotation, pain with active shoulder elevation, and pain in the anterolateral shoulder region.

Exclusion Criteria: Individuals from both groups were excluded if they:

were pregnant;
had ligamentous laxity based on positive Sulcus test, Apprehension test or anterior drawer;
had history of clavicle, scapula or humerus fracture;
history of shoulder surgery or traumatic lesion; -had adhesive capsulitis or scoliosis; - had systemic illnesses;
transpore tape allergy;
body mass index > 28kg/m2;
physical therapy treatment in the last 6 months;
bilateral symptoms;
steroid injection in the last 6 weeks;
drugs with muscle relaxant in the last 72 hours.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 59 participants (actual)

Study arms

Placebo comparator
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).
Other: Placebo ultrasound · Other: Scapular squeezing · Other: Upper trapezius stretching
Active comparator
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).
Other: Posterior shoulder mobilizations · Other: External rotators strengthening · Other: Posterior Capsule Stretching

Interventions

OtherPosterior shoulder mobilizations
A second investigator performed 5min of posterior capsule shoulder mobilization for the experimental group, 3times/week during 4 weeks.
OtherExternal rotators strengthening
Individuals performed 3x10 repetitions of external rotators strengthening in sidelying position 3times/week during 4 weeks.
OtherPlacebo ultrasound
A second investigator performed 5min of placebo ultrassound for the control group, 3times/week during 4 weeks.
OtherScapular squeezing
Individuals performed 3x10 repetitions scapular squeezing exercise 3times/week during 4 weeks.
OtherUpper trapezius stretching
Individuals performed 3x30s of upper trapezius stretching, 3times/week during 4 weeks.
OtherPosterior Capsule Stretching
Individuals performed 3x30s of posterior capsule stretching, 3times/week during 4 weeks.

What researchers measure

Primary outcomes

Scapular Kinematics at 4weeks (Pre and Post Treatment)
It was assessed in degrees with 3D system pre and post treatment.
Time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Humeral Translations at 4weeks (Pre and Post Treatment).
It was assessed in millimeters with 3D system pre and post treatment.
Time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)

Secondary outcomes

Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).
The strength was evaluated with digital dynamometer in Newton pre and post treatment.
Time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
It was measured by a digital algometer in kPa pre and post treatment.
Time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Pain and Function at 4weeks (Pre and 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.
Time frame: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)

Results

Posted Feb 15, 2017

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 flow — Overall Study
Milestone	Control Group	Experimental Group
Started	28	31
Completed	25	27
Not completed	3	4
Withdrew: Withdrawal by subject	3	4

Outcome measures

PrimaryScapular Kinematics at 4weeks (Pre and Post Treatment)

It was assessed in degrees with 3D system pre and post treatment.

Time frame:: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Reported as:: Mean · degrees

Scapular Kinematics at 4weeks (Pre and Post Treatment)
degrees	Control Group	Experimental Group
Pre Internal Rotation	34.58 ± 0.69	36.00 ± 0.68
Post Internal Rotation	34.76 ± 0.79	35.72 ± 0.77
Pre Upward Rotation	-18.12 ± 0.68	-16.47 ± 0.66
Post Upward Rotation	-17.85 ± 0.58	-14.37 ± 0.57
Pre Posterior Tilt	-3.23 ± 0.59	-2.41 ± 0.58
Post Posterior Tilt	-3.66 ± 0.60	-2.27 ± 0.59

PrimaryHumeral Translations at 4weeks (Pre and Post Treatment).

It was assessed in millimeters with 3D system pre and post treatment.

Time frame:: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Reported as:: Mean · Millimeters

Humeral Translations at 4weeks (Pre and Post Treatment).
Millimeters	Control Group	Experimental Group
Pre Anterior Translation	1.22 ± 0.36	0.85 ± 0.35
Post Anterior Translation	0.68 ± 0.32	0.96 ± 0.32
Pre Superior Translation	1.38 ± 0.28	1.21 ± 0.27
Post Superior Translation	1.12 ± 0.22	0.66 ± 0.22

SecondaryStrength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).

The strength was evaluated with digital dynamometer in Newton pre and post treatment.

Time frame:: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Reported as:: Mean · Newton

Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).
Newton	Control Group	Experimental Group
Pre External rotators strength	89.08 ± 32.86	90.96 ± 28.71
Post External rotators strength	88.98 ± 34.73	94.71 ± 27.59

SecondaryPressure Pain Threshold at 4weeks (Pre and Post Treatment).

It was measured by a digital algometer in kPa pre and post treatment.

Time frame:: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Reported as:: Mean · kPa

Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
kPa	Control Group	Experimental Group
Pre Upper Trapezius	287.40 ± 90.52	312.12 ± 135.02
Post Upper Trapezius	351.47 ± 174.59	355.82 ± 161.77
Pre Infraspinatus	351.33 ± 129.94	409.46 ± 198.58
Post Infraspinatus	403.25 ± 211.70	438.51 ± 189.71
Pre Supraspinatus	259.15 ± 86.68	321.07 ± 133.72
Post Supraspinatus	343.88 ± 159.75	353.40 ± 161.16
Pre Deltoid	301.78 ± 92.58	310.90 ± 147.84
Post Deltoid	338.00 ± 149.94	344.56 ± 143.10
Pre Levator Scapulae	256.63 ± 85.43	261.14 ± 125.89
Post Levator Scapulae	267.26 ± 108.97	269.25 ± 109.36
Pre Anterior Tibialis	711.31 ± 227.74	676.57 ± 270.60
Post Anterior Tibialis	714.12 ± 272.46	748.09 ± 256.98

SecondaryPain and Function at 4weeks (Pre and 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.

Time frame:: 4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Reported as:: Mean · scores on a scale

Pain and Function at 4weeks (Pre and Post Treatment)
scores on a scale	Control Group	Experimental Group
Pre SPADI score	46.01 ± 24.11	45.26 ± 23.22
Post SPADI score	27.10 ± 23.75	17.22 ± 15.04

Adverse events

Collected over 2 days after the pre and post evaluations.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Control Group	—	0/28 (0%)	0/28 (0%)
Experimental Group	—	0/31 (0%)	0/31 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Control Group	Experimental Group	Total
<=18 years	0	0	0
Between 18 and 65 years	28	31	59
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Control Group	Experimental Group	Total
Mean	40.08 ± 12.08	41.18 ± 12.84	40.63 ± 12.46

Sex: Female, Male
Sex: Female, Male(Participants)	Control Group	Experimental Group	Total
Female	13	8	21
Male	15	23	38

Region of Enrollment
Region of Enrollment(participants)	Control Group	Experimental Group	Total
Brazil	28	31	59

Study locations

1 site

UFSCar
São Carlos, São Paulo 13565-905, Brazil

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02353442
Lead sponsor: Universidade Federal de Sao Carlos
Responsible party: Dayana Patricia Rosa (Universidade Federal de São Carlos, Universidade Federal de Sao Carlos) — Principal investigator
First posted: Feb 2, 2015
Start date: Mar 2015
Primary completion: Aug 2016
Completion: Aug 2016
Results posted: Feb 15, 2017
Last update: Mar 21, 2017

Study contacts

Dayana Rosa, Ms

principal investigator · UFSCar

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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