Shoulder Impingement SyndromeNCT01090271
Effects of Eccentric Training for Shoulder Abductors in Subjects With Shoulder Impingement Syndrome
A study testing Isokinetic eccentric training in people with Shoulder Impingement Syndrome, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The aim of the study was to evaluate the effect of eccentric strength training for shoulder abductors on force steadiness in subjects with subacromial impingement syndrome (SIS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Isokinetic eccentric training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2007to Jun 2008
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- subjects diagnosed with Subacromial impingement syndrome by a physical therapist (the diagnosis was confirmed by an orthopaedic physician).
Who cannot join
- pregnancy
- torn rotator cuff or long head biceps tendons
- ligamentous laxity based on positive Sulcus test or a positive apprehension test
- previous shoulder or neck surgery
- hooked acromion
- systemic illnesses
- corticosteroid injection 3 months prior to evaluation
- physical therapy 6 months prior to evaluation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de Sao Carlos
São Carlos, São Paulo, 13565-905
About this study
Official title: Eccentric Training for Shoulder Abductors Improves Pain, Function and Isokinetic Performance Steadiness in Subjects With Shoulder Impingement Syndrome
The aim of the study was to evaluate the effect of eccentric strength training for shoulder abductors on force steadiness in subjects with subacromial impingement syndrome (SIS).
Read the detailed description
Although it is known that shoulder abduction in subjects with subacromial impingement syndrome (SIS) presents alterations in several parameters, as for example, in scapular and glenohumeral kinematics, the strengthening of the shoulder abductors as an intervention strategy is controversial in literature.
Strength training has been shown to be effective in reducing the fluctuations in force and had a positive effect on isometric steadiness in old adults and in healthy young subjects during bed rest. However, there are no studies that evaluated the effects of strength training on the force steadiness in subjects with SIS.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Isokinetic eccentric training
- Keywords
- Subacromial impingement syndrome, Muscle Strength, Resistance Training
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic eccentric trainingDevice
The eccentric training for the shoulder abductors was performed for 6 consecutive weeks, twice a week, on alternate days.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric training | Experimental | Not described Receives: Device: Isokinetic eccentric training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic evaluation
Measured: 2 months
Secondary outcomes (1)
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2010 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Tânia TS Salvini, PhD, Principal investigator, Universidade Federal de Sao Carlos (Sao Paulo - Brazil)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090271
- Sponsor's protocol ID
- UFSCar-214/2007
- Status last verified
- Sep 2007
- First submitted
- 18 Mar 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Training for Shoulder Abductors Improves Pain, Function and Isokinetic Performance Steadiness in Subjects With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT01090271
- Acronym / sponsor ID
- UFSCar-214/2007
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- Subacromial impingement syndrome, Muscle Strength, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Mar 2010 (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.
The aim of the study was to evaluate the effect of eccentric strength training for shoulder abductors on force steadiness in subjects with subacromial impingement syndrome (SIS).
Detailed description
Although it is known that shoulder abduction in subjects with subacromial impingement syndrome (SIS) presents alterations in several parameters, as for example, in scapular and glenohumeral kinematics, the strengthening of the shoulder abductors as an intervention strategy is controversial in literature.
Strength training has been shown to be effective in reducing the fluctuations in force and had a positive effect on isometric steadiness in old adults and in healthy young subjects during bed rest. However, there are no studies that evaluated the effects of strength training on the force steadiness in subjects with SIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eccentric training | Experimental | Device: Isokinetic eccentric training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- subjects diagnosed with Subacromial impingement syndrome by a physical therapist (the diagnosis was confirmed by an orthopaedic physician).
Key exclusion criteria (8 listed)
- pregnancy
- torn rotator cuff or long head biceps tendons
- ligamentous laxity based on positive Sulcus test or a positive apprehension test
- previous shoulder or neck surgery
- hooked acromion
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 |
|---|---|---|
| Isokinetic eccentric trainingThe eccentric training for the shoulder abductors was performed for 6 consecutive weeks, twice a week, on alternate days. | Device | Eccentric training |
Primary outcome
Isokinetic evaluation
Time frame: 2 months
1 secondary outcome
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Time frame: 2 months
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 19 Mar 2010.
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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.
Tânia TS Salvini, PhD principal investigator
Universidade Federal de Sao Carlos (Sao Paulo - Brazil)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic eccentric training in people with Shoulder Impingement Syndrome, run by Universidade Federal de Sao Carlos 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 1 inclusion and 8 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 19 Mar 2010. 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.
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?
Isokinetic evaluation (time frame: 2 months). 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 19 Mar 2010.