Disorder of ShoulderEarly Phase 1NCT01639651
The Acute Effect of a Mobilization With Movement Technique to Improve Internal Rotation of the Shoulder
A Early Phase 1 study testing Posterior capsule stretching and Mobilization with movement in people with Disorder of Shoulder and Other Musculoskeletal Disorder, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Disorder of Shoulder, Other Musculoskeletal Disorder, Contracture
- What is being tested?
- Posterior capsule stretching and Mobilization with movement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2012to Aug 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Previous surgeries of the shoulders.
- Unable to perform the evaluation or treatment due to pain.
- Performing physical therapy treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Principal Investigator
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.
Read more
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
- Being tested
- Posterior capsule stretching, Mobilization with movement
- Keywords
- Physical Therapy, Glenohumeral Internal Rotation Deficits, Joint Mobilization, Posterior capsule, Capsular contracture
- Medical subject headings
- Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior capsule stretchingOther
Also called Control group
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.
Mobilization with movementOther
Also called Experimental 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Not described Receives: Other: Posterior capsule stretching |
| Mobilization Group | Experimental | Not described Receives: Other: Mobilization with movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-intervention and four weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Rozenblit Soliaman, Federal University of São Paulo
- Investigators
- Renato R Soliaman, Principal investigator, Centro de Traumatologia do Esporte - CETE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639651
- Sponsor's protocol ID
- 02195112.7.0000.5505
- Status last verified
- Sep 2015
- First submitted
- 9 Jul 2012
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT01639651
- Acronym / sponsor ID
- 02195112.7.0000.5505
- Keywords
- Physical Therapy, Glenohumeral Internal Rotation Deficits, Joint Mobilization, Posterior capsule, Capsular contracture
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Posterior capsule stretching |
| Mobilization Group | Experimental | Other: Mobilization with movement |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Previous surgeries of the shoulders.
- Unable to perform the evaluation or treatment due to pain.
- Performing physical therapy treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior capsule stretchingAlso: Control groupControl 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. | Other | Control Group |
| Mobilization with movementAlso: Experimental GroupMobilization 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. | Other | Mobilization Group |
Primary outcome
Analyse the effectiveness of a mobilization with movement technique to improve internal rotation of the shoulder in throwers athletes with GIRD
Time frame: Immediately post-intervention and four weeks post-intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renato R Soliaman principal investigator
Centro de Traumatologia do Esporte - CETE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Posterior capsule stretching and Mobilization with movement in people with Disorder of Shoulder and Other Musculoskeletal Disorder, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyse the effectiveness of a mobilization with movement technique to improve internal rotation of the shoulder in throwers athletes with GIRD (time frame: Immediately post-intervention and four weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2015.