Shoulder Impingement SyndromePhase 2NCT00632996
Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome
A Phase 2 study testing Rehabilitation in people with Shoulder Impingement Syndrome, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purposes of this study are to: 1. determine if a rehabilitation program that consists of exercise and manual therapy reduces pain and improves quality of life in patients with shoulder subacromial impingement syndrome; 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2014
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of shoulder impingement syndrome as evidence by all 5 criteria:
- Reproduction of symptoms with impingement test: either Hawkins-Kennedy or Neer Test
- Pain during active shoulder elevation at or above 60 degrees
- Weakness of rotator cuff or pain during the Empty Can test or during resisted shoulder external rotation
- Shoulder disability: greater than or equal to 20/100 (0 = no disability)
- Able to understand written and spoken English
Who cannot join
- Severe pain; pain is > or equal to 7/10 on NPRS (0 = no pain)
- Shoulder surgery on affected shoulder
- Traumatic shoulder dislocation within the past 3 months
- Previous rehabilitation for this episode of shoulder pain
- Reproduction of shoulder pain with active or passive cervical motion
- Systemic inflammatory joint disease
- Global loss of passive shoulder ROM, indicative of adhesive capsulitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Effectiveness of Rehabilitation for Subacromial Impingement Syndrome
The purposes of this study are to:
- determine if a rehabilitation program that consists of exercise and manual therapy reduces pain and improves quality of life in patients with shoulder subacromial impingement syndrome;
- determine which patients are likely to respond to this rehabilitation program and which patients are not likely to respond to this rehabilitation program
The hypotheses are:
- the rehabilitation treatment program will result in significant changes in pain and quality of life
- there will be items from the history and examination that will identify those patients who respond favorably and those who do not respond favorably to rehabilitation at 6 weeks, 3, 6 and 12 months.
Read the detailed description
Subacromial impingement syndrome (SAIS) is the most frequent cause of shoulder pain. A variety of non-surgical treatments have been advocated to correct the impairments associated with SAIS. Clinical trials support the use of therapeutic exercise and joint mobilizations to improve pain and functional disability associated with SAIS. However, not all patients in these trials had a favorable outcome. Moreover, the effect sizes in these trials were small to moderate. Thus the purposes of this study are to 1. determine the effect of a multi-modal rehabilitation program consisting of strengthening, stretching, manual therapy to the shoulder and spine, patient education, posture, and functional re-training; and 2. identify those patients who are and who are not likely to respond to rehabilitation at the start of care.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Rehabilitation
- Keywords
- shoulder pain, shoulder impingement syndrome, manual therapy, rehabilitation
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Also called Physical Therapy, Manual Therapy
Exercise, manual therapy, patient education, posture, home exercise program
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder disability
Measured: 6 week and 3, 6, 12 months
Secondary outcomes (5)
Patient satisfaction
Measured: 6 weeks and 3, 6, 12 months
Quality of life
Measured: 6 weeks and 3, 6, 12 months
Pain with rest, normal activities, and strenuous activities
Measured: 6 weeks and 3, 6, 12 months
Patient perceived global rating of effect
Measured: 6 weeks and 3 months
Additional healthcare utilization and medication use
Measured: 6 weeks and 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Athletic Trainers' Association Research & Education Foundation (NATA Foundation), University of North Florida, Arcadia University
- Responsible party
- Sponsor
- Investigators
- Lori A Michener, PhD, PT, ATC, Principal investigator, Virginia Commonwealth UniversityPhillip W McClure, PhD, PT, Principal investigator, Arcadia UniversityAngela R Tate, PhD, PT, Study director, Arcadia UniversityIan A Young, PT, Study chair, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632996
- Sponsor's protocol ID
- HM10320
- Other IDs
- Proposal #:PT101875
- Status last verified
- Dec 2015
- First submitted
- 3 Mar 2008
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tate AR, McClure PW, Young IA, Salvatori R, Michener LA. Comprehensive impairment-based exercise and manual therapy intervention for patients with subacromial impingement syndrome: a case series. J Orthop Sports Phys Ther. 2010 Aug;40(8):474-93. doi: 10.2519/jospt.2010.3223.
PubMed 20710088
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Rehabilitation for Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT00632996
- Acronym / sponsor ID
- HM10320
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- shoulder pain, shoulder impingement syndrome, manual therapy, rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Athletic Trainers' Association Research & Education Foundation (NATA Foundation), University of North Florida, Arcadia University
- Study start
- Jan 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Mar 2008 (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 purposes of this study are to:
- determine if a rehabilitation program that consists of exercise and manual therapy reduces pain and improves quality of life in patients with shoulder subacromial impingement syndrome;
- determine which patients are likely to respond to this rehabilitation program and which patients are not likely to respond to this rehabilitation program
The hypotheses are:
- the rehabilitation treatment program will result in significant changes in pain and quality of life
- there will be items from the history and examination that will identify those patients who respond favorably and those who do not respond favorably to rehabilitation at 6 weeks, 3, 6 and 12 months.
Detailed description
Subacromial impingement syndrome (SAIS) is the most frequent cause of shoulder pain. A variety of non-surgical treatments have been advocated to correct the impairments associated with SAIS. Clinical trials support the use of therapeutic exercise and joint mobilizations to improve pain and functional disability associated with SAIS. However, not all patients in these trials had a favorable outcome. Moreover, the effect sizes in these trials were small to moderate. Thus the purposes of this study are to 1. determine the effect of a multi-modal rehabilitation program consisting of strengthening, stretching, manual therapy to the shoulder and spine, patient education, posture, and functional re-training; and 2. identify those patients who are and who are not likely to respond to rehabilitation at the start of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Rehabilitation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of shoulder impingement syndrome as evidence by all 5 criteria:
Key exclusion criteria (7 listed)
- Severe pain; pain is > or equal to 7/10 on NPRS (0 = no pain)
- Shoulder surgery on affected shoulder
- Traumatic shoulder dislocation within the past 3 months
- Previous rehabilitation for this episode of shoulder pain
- Reproduction of shoulder pain with active or passive cervical motion
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 |
|---|---|---|
| RehabilitationAlso: Physical Therapy, Manual TherapyExercise, manual therapy, patient education, posture, home exercise program | Other | 1 |
Primary outcome
Shoulder disability
Time frame: 6 week and 3, 6, 12 months
5 secondary outcomes
Patient satisfaction
Time frame: 6 weeks and 3, 6, 12 months
Quality of life
Time frame: 6 weeks and 3, 6, 12 months
Pain with rest, normal activities, and strenuous activities
Time frame: 6 weeks and 3, 6, 12 months
Patient perceived global rating of effect
Time frame: 6 weeks and 3 months
Additional healthcare utilization and medication use
Time frame: 6 weeks and 3, 6, 12 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 21 Dec 2015.
- Derived from this study: PubMed 20710088Tate AR, McClure PW, Young IA, Salvatori R, Michener LA. Comprehensive impairment-based exercise and manual therapy intervention for patients with subacromial impingement syndrome: a case series. J Orthop Sports Phys Ther. 2010 Aug;40(8):474-93. doi: 10.2519/jospt.2010.3223.
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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.
Lori A Michener, PhD, PT, ATC principal investigator
Virginia Commonwealth University
Phillip W McClure, PhD, PT principal investigator
Arcadia University
Angela R Tate, PhD, PT study director
Arcadia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rehabilitation in people with Shoulder Impingement Syndrome, run by Virginia Commonwealth University 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 6 inclusion and 7 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 21 Dec 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Shoulder disability (time frame: 6 week and 3, 6, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00632996, which also lists 1 linked publication.
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 21 Dec 2015.