Shoulder Impingement SyndromeNCT00633451
Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome
A study testing Manual Therapy and Exercise and Exercise Only in people with Shoulder Impingement Syndrome, run by Proaxis Therapy at 1 site in United States.
Trial summary
The purpose of this randomized double-blind clinical trial is to determine the effectiveness of manual therapy for patients with subacromial impingement syndrome of the shoulder. 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?
- Manual Therapy and Exercise and Exercise Only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Sep 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms associated with athletic activity (35% of patients)
- Diagnosis of shoulder impingement syndrome as evidence by all 3 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: 25/100 (0 = no disability)
- Able to understand written and spoken
Who cannot join
- Severe pain; pain is > 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
Show all 13Show fewer
- Global loss of passive shoulder ROM, indicative of adhesive capsulitis
- Full-thickness rotator cuff tear, as evidenced by any one of the following:
- Markedly reduced shoulder external rotation strength
- Drop arm test
- External rotation lag sign
- Lift off test
- Positive findings on MRI or ultrasonography
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only
The purpose of this randomized double-blind clinical trial is to determine the effectiveness of manual therapy for patients with subacromial impingement syndrome of the shoulder. We hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and spine will be more effective in reducing pain and shoulder disability at short-term (6 wk) and long-term (3, 6, 12 months) as compared to therapeutic exercise only.
Read the detailed description
Subacromial impingement syndrome (SAIS) is a frequent cause of shoulder pain. Clinical trials investigating the effectiveness of manual therapy have demonstrated improvements in outcomes when manual therapy has been added to a program of therapeutic exercise. However, the these clinical trials (3) have significant limitations and generalizability. Two of the three 3 trials had a small number of subjects (14 \& 22 subjects) and all 3 trials had only short term follow up (<12 weeks) and used non-validated self report outcome measures. These limitations reduce the confidence with which clinicians can apply these results to the patients they treat with SAIS. Clear evidence is needed to justify the cost and clinician time required to perform manual therapy in the delivery of patient care. Therefore, the purpose of this randomized clinical trial is to examine the short-term and long-term effectiveness of manual therapy in addition to therapeutic exercise as compared to therapeutic exercise only in patients diagnosed with SAIS.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Manual Therapy and Exercise, Exercise Only
- 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.
Manual Therapy and ExerciseOther
Also called Manual Therapy and Therapeutic Exercise
Manual therapy to the thoracic spine and shoulder, and therapeutic exercise to the shoulder and spine applied in a prescribed progression of therapeutic exercise aimed at improving shoulder function.
Exercise OnlyOther
Also called Therapeutic Exercise
A prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Manual Therapy + Exercise Receives: Other: Manual Therapy and Exercise |
| 2 | Active comparator | Exercise Only Receives: Other: Exercise Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder disability and pain
Measured: 6 weeks and 3, 6,12 months
Secondary outcomes (2)
Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication
Measured: 6 weeks, and 3, 6, 12 months
Patient perceived global rating of effect
Measured: 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2012
- Study completionSep 2012
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proaxis Therapy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Virginia Commonwealth University, Arcadia University, National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
- Responsible party
- Principal investigator, Chuck Thigpen, Proaxis Therapy
- Investigators
- Charles A Thigpen, PhD, PT, ATC, Principal investigator, University of North FloridaLori A Michener, PhD, PT, ATC, Principal investigator, Virginia Commonwealth UniversityPhil McClure, PhD, PT, Principal investigator, Arcadia UniversityAngela R Tate, PhD, PT, Study director, Arcadia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633451
- Sponsor's protocol ID
- 07-173
- Status last verified
- Mar 2013
- First submitted
- 4 Mar 2008
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Rehabilitation for Subacromial Impingement Syndrome: A Comparison of Manual Therapy + Exercise to Exercise Only
- ClinicalTrials.gov ID
- NCT00633451
- Acronym / sponsor ID
- 07-173
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- shoulder pain, shoulder impingement syndrome, manual therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Proaxis TherapyIndustry (pharma, biotech, devices)
- Collaborators
- Virginia Commonwealth University, Arcadia University, National Athletic Trainers' Association Research & Education Foundation (NATA Foundation)
- Study start
- Feb 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 12 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 purpose of this randomized double-blind clinical trial is to determine the effectiveness of manual therapy for patients with subacromial impingement syndrome of the shoulder. We hypothesize that a combination of therapeutic exercise and manual therapy to the shoulder and spine will be more effective in reducing pain and shoulder disability at short-term (6 wk) and long-term (3, 6, 12 months) as compared to therapeutic exercise only.
Detailed description
Subacromial impingement syndrome (SAIS) is a frequent cause of shoulder pain. Clinical trials investigating the effectiveness of manual therapy have demonstrated improvements in outcomes when manual therapy has been added to a program of therapeutic exercise. However, the these clinical trials (3) have significant limitations and generalizability. Two of the three 3 trials had a small number of subjects (14 \& 22 subjects) and all 3 trials had only short term follow up (<12 weeks) and used non-validated self report outcome measures. These limitations reduce the confidence with which clinicians can apply these results to the patients they treat with SAIS. Clear evidence is needed to justify the cost and clinician time required to perform manual therapy in the delivery of patient care. Therefore, the purpose of this randomized clinical trial is to examine the short-term and long-term effectiveness of manual therapy in addition to therapeutic exercise as compared to therapeutic exercise only in patients diagnosed with SAIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Manual Therapy and ExerciseManual Therapy + Exercise |
| 2 | Active comparator | Other: Exercise OnlyExercise Only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Symptoms associated with athletic activity (35% of patients)
- Diagnosis of shoulder impingement syndrome as evidence by all 3 criteria:
- Shoulder disability: 25/100 (0 = no disability)
- Able to understand written and spoken
Key exclusion criteria (13 listed)
- Severe pain; pain is > 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 |
|---|---|---|
| Manual Therapy and ExerciseAlso: Manual Therapy and Therapeutic ExerciseManual therapy to the thoracic spine and shoulder, and therapeutic exercise to the shoulder and spine applied in a prescribed progression of therapeutic exercise aimed at improving shoulder function. | Other | 1 |
| Exercise OnlyAlso: Therapeutic ExerciseA prescribed progression of therapeutic exercise for the shoulder and spine aimed at improving shoulder function | Other | 2 |
Primary outcome
Shoulder disability and pain
Time frame: 6 weeks and 3, 6,12 months
2 secondary outcomes
Patient satisfaction Quality of life (SF-36) Additional healthcare utilization and medication
Time frame: 6 weeks, and 3, 6, 12 months
Patient perceived global rating of effect
Time frame: 6 weeks and 3 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 28 Mar 2013.
- Related InfoLink provided by the sponsor.
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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.
Charles A Thigpen, PhD, PT, ATC principal investigator
University of North Florida
Lori A Michener, PhD, PT, ATC principal investigator
Virginia Commonwealth University
Phil McClure, PhD, PT principal investigator
Arcadia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Exercise and Exercise Only in people with Shoulder Impingement Syndrome, run by Proaxis Therapy 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 7 inclusion and 13 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 28 Mar 2013. 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?
Shoulder disability and pain (time frame: 6 weeks 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?
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 28 Mar 2013.