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Changes in Subjects With Posterior Capsule Tightness

Biomechanical and Neurophysiological Changes in Subjects With Posterior Capsule Tightness - Evaluation and Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02353442
Enrollment
59
Registered
2015-02-02
Start date
2015-03-31
Completion date
2016-08-31
Last updated
2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

Pain, Rotator cuff, Stretching, Mobilization, Scapula, Posterior capsule

Brief summary

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

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.

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.

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.

Individuals performed 3x30s of posterior capsule stretching, 3times/week during 4 weeks.

Sponsors

Universidade Federal de Sao Carlos
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

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

Countries

Brazil

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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.
28
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.
31
Total59

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject34

Baseline characteristics

CharacteristicExperimental GroupControl GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
31 Participants28 Participants59 Participants
Age, Continuous41.18 years
STANDARD_DEVIATION 12.84
40.08 years
STANDARD_DEVIATION 12.08
40.63 years
STANDARD_DEVIATION 12.46
Region of Enrollment
Brazil
31 participants28 participants59 participants
Sex: Female, Male
Female
8 Participants13 Participants21 Participants
Sex: Female, Male
Male
23 Participants15 Participants38 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 280 / 31
serious
Total, serious adverse events
0 / 280 / 31

Outcome results

Primary

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)

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupHumeral Translations at 4weeks (Pre and Post Treatment).Pre Anterior Translation1.22 MillimetersStandard Error 0.36
Control GroupHumeral Translations at 4weeks (Pre and Post Treatment).Post Anterior Translation0.68 MillimetersStandard Error 0.32
Control GroupHumeral Translations at 4weeks (Pre and Post Treatment).Pre Superior Translation1.38 MillimetersStandard Error 0.28
Control GroupHumeral Translations at 4weeks (Pre and Post Treatment).Post Superior Translation1.12 MillimetersStandard Error 0.22
Experimental GroupHumeral Translations at 4weeks (Pre and Post Treatment).Post Superior Translation0.66 MillimetersStandard Error 0.22
Experimental GroupHumeral Translations at 4weeks (Pre and Post Treatment).Pre Anterior Translation0.85 MillimetersStandard Error 0.35
Experimental GroupHumeral Translations at 4weeks (Pre and Post Treatment).Pre Superior Translation1.21 MillimetersStandard Error 0.27
Experimental GroupHumeral Translations at 4weeks (Pre and Post Treatment).Post Anterior Translation0.96 MillimetersStandard Error 0.32
Primary

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)

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Pre Internal Rotation34.58 degreesStandard Error 0.69
Control GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Post Internal Rotation34.76 degreesStandard Error 0.79
Control GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Pre Upward Rotation-18.12 degreesStandard Error 0.68
Control GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Post Upward Rotation-17.85 degreesStandard Error 0.58
Control GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Pre Posterior Tilt-3.23 degreesStandard Error 0.59
Control GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Post Posterior Tilt-3.66 degreesStandard Error 0.6
Experimental GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Pre Posterior Tilt-2.41 degreesStandard Error 0.58
Experimental GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Pre Internal Rotation36.00 degreesStandard Error 0.68
Experimental GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Post Upward Rotation-14.37 degreesStandard Error 0.57
Experimental GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Post Internal Rotation35.72 degreesStandard Error 0.77
Experimental GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Post Posterior Tilt-2.27 degreesStandard Error 0.59
Experimental GroupScapular Kinematics at 4weeks (Pre and Post Treatment)Pre Upward Rotation-16.47 degreesStandard Error 0.66
Secondary

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)

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupPain and Function at 4weeks (Pre and Post Treatment)Pre SPADI score46.01 scores on a scaleStandard Deviation 24.11
Control GroupPain and Function at 4weeks (Pre and Post Treatment)Post SPADI score27.10 scores on a scaleStandard Deviation 23.75
Experimental GroupPain and Function at 4weeks (Pre and Post Treatment)Pre SPADI score45.26 scores on a scaleStandard Deviation 23.22
Experimental GroupPain and Function at 4weeks (Pre and Post Treatment)Post SPADI score17.22 scores on a scaleStandard Deviation 15.04
Secondary

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)

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Upper Trapezius287.40 kPaStandard Deviation 90.52
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Upper Trapezius351.47 kPaStandard Deviation 174.59
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Infraspinatus351.33 kPaStandard Deviation 129.94
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Infraspinatus403.25 kPaStandard Deviation 211.7
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Supraspinatus259.15 kPaStandard Deviation 86.68
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Supraspinatus343.88 kPaStandard Deviation 159.75
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Deltoid301.78 kPaStandard Deviation 92.58
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Deltoid338.00 kPaStandard Deviation 149.94
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Levator Scapulae256.63 kPaStandard Deviation 85.43
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Levator Scapulae267.26 kPaStandard Deviation 108.97
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Anterior Tibialis711.31 kPaStandard Deviation 227.74
Control GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Anterior Tibialis714.12 kPaStandard Deviation 272.46
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Anterior Tibialis676.57 kPaStandard Deviation 270.6
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Upper Trapezius312.12 kPaStandard Deviation 135.02
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Deltoid310.90 kPaStandard Deviation 147.84
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Upper Trapezius355.82 kPaStandard Deviation 161.77
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Levator Scapulae269.25 kPaStandard Deviation 109.36
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Infraspinatus409.46 kPaStandard Deviation 198.58
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Deltoid344.56 kPaStandard Deviation 143.1
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Infraspinatus438.51 kPaStandard Deviation 189.71
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Anterior Tibialis748.09 kPaStandard Deviation 256.98
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Supraspinatus321.07 kPaStandard Deviation 133.72
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Pre Levator Scapulae261.14 kPaStandard Deviation 125.89
Experimental GroupPressure Pain Threshold at 4weeks (Pre and Post Treatment).Post Supraspinatus353.40 kPaStandard Deviation 161.16
Secondary

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)

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupStrength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).Pre External rotators strength89.08 NewtonStandard Deviation 32.86
Control GroupStrength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).Post External rotators strength88.98 NewtonStandard Deviation 34.73
Experimental GroupStrength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).Pre External rotators strength90.96 NewtonStandard Deviation 28.71
Experimental GroupStrength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).Post External rotators strength94.71 NewtonStandard Deviation 27.59

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026