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Changes in Subjects With Posterior Capsule Tightness

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Posterior shoulder mobilizations
External rotators strengthening
Placebo ultrasound
Scapular squeezing
Upper trapezius stretching
Posterior Capsule Stretching
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Pain, Rotator cuff, Stretching, Mobilization, Scapula, Posterior capsule

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UFSCar

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control group

Experimental group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
It was measured by a digital algometer in kPa pre and 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.

Full Information

First Posted
January 18, 2015
Last Updated
February 14, 2017
Sponsor
Universidade Federal de Sao Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT02353442
Brief Title
Changes in Subjects With Posterior Capsule Tightness
Official Title
Biomechanical and Neurophysiological Changes in Subjects With Posterior Capsule Tightness - Evaluation and Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Sao Carlos

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Pain, Rotator cuff, Stretching, Mobilization, Scapula, Posterior capsule

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Experimental group
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Posterior shoulder mobilizations
Intervention Description
A second investigator performed 5min of posterior capsule shoulder mobilization for the experimental group, 3times/week during 4 weeks.
Intervention Type
Other
Intervention Name(s)
External rotators strengthening
Intervention Description
Individuals performed 3x10 repetitions of external rotators strengthening in sidelying position 3times/week during 4 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo ultrasound
Intervention Description
A second investigator performed 5min of placebo ultrassound for the control group, 3times/week during 4 weeks.
Intervention Type
Other
Intervention Name(s)
Scapular squeezing
Intervention Description
Individuals performed 3x10 repetitions scapular squeezing exercise 3times/week during 4 weeks.
Intervention Type
Other
Intervention Name(s)
Upper trapezius stretching
Intervention Description
Individuals performed 3x30s of upper trapezius stretching, 3times/week during 4 weeks.
Intervention Type
Other
Intervention Name(s)
Posterior Capsule Stretching
Intervention Description
Individuals performed 3x30s of posterior capsule stretching, 3times/week during 4 weeks.
Primary Outcome Measure Information:
Title
Scapular Kinematics at 4weeks (Pre and Post Treatment)
Description
It was assessed in degrees with 3D system pre and post treatment.
Time Frame
4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)
Title
Humeral Translations at 4weeks (Pre and Post Treatment).
Description
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 Outcome Measure Information:
Title
Strength of the Shoulder External Rotators at 4weeks (Pre and Post Treatment).
Description
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)
Title
Pressure Pain Threshold at 4weeks (Pre and Post Treatment).
Description
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)
Title
Pain and Function at 4weeks (Pre and Post Treatment)
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dayana Rosa, Ms
Organizational Affiliation
UFSCar
Official's Role
Principal Investigator
Facility Information:
Facility Name
UFSCar
City
São Carlos
State/Province
São Paulo
ZIP/Postal Code
13565-905
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Changes in Subjects With Posterior Capsule Tightness

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