NCT02353442

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 15, 2017

Completed
Last Updated

March 21, 2017

Status Verified

February 1, 2017

Enrollment Period

1.4 years

First QC Date

January 18, 2015

Results QC Date

August 26, 2016

Last Update Submit

February 14, 2017

Conditions

Keywords

PainRotator cuffStretchingMobilizationScapulaPosterior capsule

Outcome Measures

Primary Outcomes (2)

  • Scapular Kinematics at 4weeks (Pre and 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).

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

    4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)

Secondary Outcomes (3)

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

    4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)

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

    4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)

  • Pain and Function at 4weeks (Pre and Post Treatment)

    4 weeks: Baseline (pre-treatment), and 4 weeks (post-treatment)

Study Arms (2)

Control group

PLACEBO COMPARATOR

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 ultrasoundOther: Scapular squeezingOther: Upper trapezius stretching

Experimental group

ACTIVE COMPARATOR

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 mobilizationsOther: External rotators strengtheningOther: Posterior Capsule Stretching

Interventions

A second investigator performed 5min of posterior capsule shoulder mobilization for the experimental group, 3times/week during 4 weeks.

Experimental group

Individuals performed 3x10 repetitions of external rotators strengthening in sidelying position 3times/week during 4 weeks.

Experimental group

A second investigator performed 5min of placebo ultrassound for the control group, 3times/week during 4 weeks.

Control group

Individuals performed 3x10 repetitions scapular squeezing exercise 3times/week during 4 weeks.

Control group

Individuals performed 3x30s of upper trapezius stretching, 3times/week during 4 weeks.

Control group

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

Experimental group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UFSCar

São Carlos, São Paulo, 13565-905, Brazil

Location

MeSH Terms

Conditions

Shoulder PainPain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dayana Rosa
Organization
São Carlos Fedetal University

Study Officials

  • Dayana Rosa, Ms

    UFSCar

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Universidade Federal de São Carlos

Study Record Dates

First Submitted

January 18, 2015

First Posted

February 2, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 21, 2017

Results First Posted

February 15, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations