Subacromial Impingement SyndromeNCT02478567
Exercise Training Sequence for Subacromial Impingement Syndrome
A study testing Rotator Cuff Training and Scapular Training in people with Subacromial Impingement Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Randomized crossover trial evaluating the impact of exercise training sequence of axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Rotator Cuff Training and Scapular Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jan 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age
- diagnosis of Neer Stage I/II subacromial impingement with a primary pain complaint in the shoulder and/or upper arm
- presence of at least two of the following findings: painful arc, weakness in external rotation, positive impingement sign (Hawkins-Kennedy or Neer/Walsh tests), pain and/or weakness with resistance to internal rotation, external rotation, or scapular plane elevation.
Who cannot join
- concurrent medical co-morbidities including pregnancy, diabetes, and rheumatoid arthritis -
- osteoarthritis greater than grade 2 on the Kellgren-Lawrence scale
- current diagnosis and/or previous history of glenohumeral instability or dislocation
- full-thickness rotator cuff tear
- adhesive capsulitis
- fractures of the scapula, clavicle or humerus
Show all 9Show fewer
- scapulothoracic or rotator cuff paresis
- shoulder surgery in past year
- inability to speak the English language at a level sufficient to obtain informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Axioscapular and Rotator Cuff Exercise Training Sequence in Patients With Subacromial Impingement Syndrome: A Randomized Crossover Trial
Randomized crossover trial evaluating the impact of exercise training sequence of axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement syndrome.
Read the detailed description
While physical therapy is an effective element in the rehabilitation of rotator cuff (RC) disease, the most effective sequence of training interventions has not been defined. The purpose of this study is to determine if there is a difference in pain or function in patients who are given RC strengthening prior to or after initiating scapular stabilization exercises.
The study was a prospective randomized crossover design. 26 men and 14 women, mean age 51, diagnosed with subacromial impingement syndrome (SAIS) were randomly assigned to one of two groups for a comprehensive and standardized rehabilitation program over six visits at an orthopedic outpatient clinic. One group was prescribed a 4-week program of scapular stabilization exercises while the other group began with RC strengthening exercises. The crossover design had each group add the previously excluded four exercises to their second month of rehabilitation.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Rotator Cuff Training, Scapular 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.
Rotator Cuff TrainingOther
Also called exercise
four specific band-resisted strength training exercises for scapula
Scapular TrainingOther
Also called exercise
four specific band-resisted strength training exercises for rotator cuff
| Study group | Role | What they receive |
|---|---|---|
| Scapular Training | Experimental | Initiated scapular training exercise for the first 4 weeks followed by addition of rotator cuff exercises the next four weeks Receives: Other: Scapular Training |
| Rotator Cuff Training | Experimental | initiated rotator cuff training exercise for the first 4 weeks followed by addition of scapular training exercises the next four weeks. Receives: Other: Rotator Cuff Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder Elbow Surgeon's Outcome Score
self-report of function
Measured: 16 weeks
Numeric Pain Score
pain levels
Measured: 16 weeks
Global Rating of Change
patient satisfaction
Measured: 16 weeks
Global Percentage of Improvement
patient perception of status
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startAug 2012
- Primary completionAug 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ed Mulligan, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02478567
- Sponsor's protocol ID
- 052012-017
- Status last verified
- May 2016
- First submitted
- 16 Jun 2015
- Last updated
- 17 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Axioscapular and Rotator Cuff Exercise Training Sequence in Patients With Subacromial Impingement Syndrome: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT02478567
- Acronym / sponsor ID
- 052012-017
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Jun 2015 (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.
Randomized crossover trial evaluating the impact of exercise training sequence of axioscapular and rotator cuff exercises in patients diagnosed with subacromial impingement syndrome.
Detailed description
While physical therapy is an effective element in the rehabilitation of rotator cuff (RC) disease, the most effective sequence of training interventions has not been defined. The purpose of this study is to determine if there is a difference in pain or function in patients who are given RC strengthening prior to or after initiating scapular stabilization exercises.
The study was a prospective randomized crossover design. 26 men and 14 women, mean age 51, diagnosed with subacromial impingement syndrome (SAIS) were randomly assigned to one of two groups for a comprehensive and standardized rehabilitation program over six visits at an orthopedic outpatient clinic. One group was prescribed a 4-week program of scapular stabilization exercises while the other group began with RC strengthening exercises. The crossover design had each group add the previously excluded four exercises to their second month of rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scapular Training | Experimental | Other: Scapular TrainingInitiated scapular training exercise for the first 4 weeks followed by addition of rotator cuff exercises the next four weeks |
| Rotator Cuff Training | Experimental | Other: Rotator Cuff Traininginitiated rotator cuff training exercise for the first 4 weeks followed by addition of scapular training exercises the next four weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-80 years of age
- diagnosis of Neer Stage I/II subacromial impingement with a primary pain complaint in the shoulder and/or upper arm
- presence of at least two of the following findings: painful arc, weakness in external rotation, positive impingement sign (Hawkins-Kennedy or Neer/Walsh tests), pain and/or weakness with resistance to internal rotation, external rotation, or scapular plane elevation.
Key exclusion criteria (9 listed)
- concurrent medical co-morbidities including pregnancy, diabetes, and rheumatoid arthritis -
- osteoarthritis greater than grade 2 on the Kellgren-Lawrence scale
- current diagnosis and/or previous history of glenohumeral instability or dislocation
- full-thickness rotator cuff tear
- adhesive capsulitis
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 |
|---|---|---|
| Rotator Cuff TrainingAlso: exercisefour specific band-resisted strength training exercises for scapula | Other | Rotator Cuff Training |
| Scapular TrainingAlso: exercisefour specific band-resisted strength training exercises for rotator cuff | Other | Scapular Training |
Primary outcome
American Shoulder Elbow Surgeon's Outcome Score
Time frame: 16 weeks
self-report of function
Numeric Pain Score
Time frame: 16 weeks
pain levels
Global Rating of Change
Time frame: 16 weeks
patient satisfaction
Global Percentage of Improvement
Time frame: 16 weeks
patient perception of status
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 17 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotator Cuff Training and Scapular Training in people with Subacromial Impingement Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 9 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 17 May 2016. 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 United States. 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?
American Shoulder Elbow Surgeon's Outcome Score (time frame: 16 weeks). The study lists 4 primary outcomes in all. 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 17 May 2016.