Changes in Subjects With Posterior Capsule Tightness

February 14, 2017 updated by: Dayana Patricia Rosa, Universidade Federal de Sao Carlos

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 13565-905
        • UFSCar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
A second investigator performed 5min of placebo ultrassound for the control group, 3times/week during 4 weeks.
Other: Scapular squeezing
Individuals performed 3x10 repetitions scapular squeezing exercise 3times/week during 4 weeks.
Other: Upper trapezius stretching
Individuals performed 3x30s of upper trapezius stretching, 3times/week during 4 weeks.
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
A second investigator performed 5min of posterior capsule shoulder mobilization for the experimental group, 3times/week during 4 weeks.
Other: External rotators strengthening
Individuals performed 3x10 repetitions of external rotators strengthening in sidelying position 3times/week during 4 weeks.
Other: Posterior Capsule Stretching
Individuals performed 3x30s of posterior capsule stretching, 3times/week during 4 weeks.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Sao Carlos

Investigators

  • Principal Investigator: Dayana Rosa, Ms, UFSCar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 18, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Actual)

March 21, 2017

Last Update Submitted That Met QC Criteria

February 14, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 860.648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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