NCT01639651

Brief Summary

For many years researchers have been documented that the shoulder of the throwing athlete acquires a increase in external rotation of the dominant limb compared to the contralateral side.This fact is followed with a loss of the internal rotation of the shoulder, which is related with a higher rate of injuries in this joint and it´s known as Glenohumeral Internal Rotation Deficit (GIRD). Among the approaches for this condition the literature is inconclusive due to the low methodological quality of clinical trials made,however, the manual therapy has been used with success to relief the pain and restore the range of motion. The purpose of this study is to analyse the effectiveness of a mobilization with movement technique to improve the internal rotation of the shoulder in throwing athletes with GIRD. It will be a randomized controlled trial with the CONSORT bases with 40 participants that will be divided into two groups:

  • Control group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation)of both limbs, upper limb active movements to warm-up (five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) and revaluation immediately post-intervention and four weeks post-intervention.
  • Mobilization group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation)of both limbs, upper limb active movements to warm-up(five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) plus a mobilization with movement technique to improve internal rotation of the dominant shoulder (three sets of 10 repetitions)and revaluation immediately post-intervention and four weeks post-intervention. To evaluate the range of movement it will be use a standard goniometer with an attached customizes bubble inclinometer to ensure proper perpendicular alignment of the goniometer to the ground. The investigators hypothesis is that both group will have improvements in the internal rotation of the dominant shoulder, however, the mobilization group will have a statistically significant difference compared to control group immediately post-intervention. Four weeks post-intervention this difference will equalize, because of the only intervention applied. Results will be expressed as hazard ratios (HR) with their respective confidence intervals at 95% and adopting α = 0.05. All analyzes will be performed by SPSS version 17.0

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jun 2012

Typical duration for early_phase_1

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

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 2, 2015

Status Verified

September 1, 2015

Enrollment Period

3.2 years

First QC Date

July 9, 2012

Last Update Submit

September 1, 2015

Conditions

Keywords

Physical TherapyGlenohumeral Internal Rotation DeficitsJoint MobilizationPosterior capsuleCapsular contracture

Outcome Measures

Primary Outcomes (1)

  • Analyse the effectiveness of a mobilization with movement technique to improve internal rotation of the shoulder in throwers athletes with GIRD

    The 40 patients will be divided in two groups of 20. Both will perform a evaluation of the internal and external rotation of the shoulders to determine the individual internal rotation deficit of the dominant shoulder compared to the contralateral side. One group (Control) will perform what the literature recommends (Stretch of the posterior capsule), and the other group (Mobilization) will add to the control intervention a mobilization with movement technique to improve the internal rotation deficit which was identified previously.

    Immediately post-intervention and four weeks post-intervention

Study Arms (2)

Control Group

ACTIVE COMPARATOR
Other: Posterior capsule stretching

Mobilization Group

EXPERIMENTAL
Other: Mobilization with movement

Interventions

Control group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation)for both limbs, upper limb active movements to warm-up (five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) and revaluation immediately post-intervention and four weeks post-intervention.

Also known as: Control group
Control Group

Mobilization group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation) for both limbs, upper limb active movements to warm-up (five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) plus a mobilization with movement to improve internal rotation of the dominant shoulder (three sets of 10 repetitions)and revaluation immediately post-intervention and four weeks post-intervention.

Also known as: Experimental Group
Mobilization Group

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Athletes that practice at least 10 hours of throwing sports.
  • Glenohumeral internal rotation deficits of the dominant shoulder compare to the non-dominant limb.
  • Agree to participate and signing the informed consent approved for the Federal University of São Paulo ethics committee.

You may not qualify if:

  • Previous surgeries of the shoulders.
  • Unable to perform the evaluation or treatment due to pain.
  • Performing physical therapy treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04039-001, Brazil

Location

MeSH Terms

Conditions

Contracture

Interventions

Control GroupsMovement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesMuscular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethodsPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Renato R Soliaman

    Centro de Traumatologia do Esporte - CETE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Acute Effect of a Mobilization With Movement Technique to Improve Internal Rotation of the Shoulder: a Randomized Controlled Trial

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 13, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-09

Locations