Subacromial DecompressionNCT01054326
Effects of Supervised Physical Therapy With Early Activation of the Rotator Cuff Versus Home Exercises in Patients After Arthroscopic Subacromial Decompression
A study testing Exercises in people with Subacromial Decompression, run by Linkoeping University.
Trial summary
The objective of this study was to evaluate and compare two different post-surgical rehabilitation strategies, Rehabilitation supervised by a physical therapist including exercises with progressive early activation of the rotator cuff versus basic home exercises regarding shoulder function, pain, health related… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Subacromial Decompression
- What is being tested?
- Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jan 2007
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subacromial impingement verified with Neer impingement test
- At least 6 month duration of pain
- Treated in primary care without satisfactory results for at least three months.
- Typical history and pain location. Scheduled for surgery (subacromial decompression)
- Three of these four tests must be positive:
- Neer impingement test
- Hawkins-Kennedy impingement sign Jobe supraspinatus test
- Painful arc 60-120 degree
Who cannot join
- Radiological findings of malignancy osteoarthritis, fractures
- Polyarthritis or fibromyalgia
- Pathological hyper laxity
- Lack of communication skills that prevent the use of outcome measurements
- Cervical spine pathology
About this study
The objective of this study was to evaluate and compare two different post-surgical rehabilitation strategies, Rehabilitation supervised by a physical therapist including exercises with progressive early activation of the rotator cuff versus basic home exercises regarding shoulder function, pain, health related quality of life and return to work after arthroscopic subacromial decompression.
Read the detailed description
Patients scheduled for surgery (arthroscopic subacromial decompression)and in the age 25-65 were offered to participate in the study. After surgery they were randomized to either Supervised Physical therapy with early activation of the rotator cuff (PT-group) or to home exercises (H-group). Patients in the PT group met the physical therapist twice a week for exercises and in between these visits they did their exercises at home daily. The H-group did home exercises daily. Shoulder function and pain(primary outcomes)and health related quality of life, returning to work(secondary outcomes)were assessed before surgery, one week after(baseline), 1,2,3 and 6 months after surgery by an independent physical therapist.
- Conditions
- Subacromial Decompression
- Being tested
- Exercises
- Keywords
- arthroscopic subacromial decompression, exercise, physical therapy, rotator cuff, shoulder impingement syndrome, Subacromial impingement after arthroscopic subacromial decompression
- Medical subject headings
- Motor Activity, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
| Study group | Role | What they receive |
|---|---|---|
| Supervised physical therapy focusing of rotatorcuff exercises | Experimental | Patients did specific exercises supervised by a physical therapists twice a week during two months. Focus was on early activation of rotator cuff and scapula stabilizers following different phases in a rehabilitation program Assessments before surgery,1 week after as well as 1,2,3 and 6 months after surgery. Receives: Other: Exercises |
| Home exercises | Active comparator | Patients did home exercises following a programme during three months. Assessment considering shoulder function and pain was done before surgery, 1w after as well as 1,2,3 and 6 months after surgery, Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function and pain
Measured: before surgery, 1 w (baseline, 1,2,3 and 6 month after surgery
Secondary outcomes (1)
Health related quality of life and returning to work
Measured: before surhery and 1 w(baseline)1,2,3 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2003
- Primary completionJan 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial DecompressionStudies of the same condition, open and under way.
- More trials run by Linkoeping 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Kalmar County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054326
- Sponsor's protocol ID
- DNR 02-37
- Status last verified
- Jan 2006
- First submitted
- 21 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supervised Physical Therapy With Early Activation of the Rotator Cuff Versus Home Exercises in Patients After Arthroscopic Subacromial Decompression
- ClinicalTrials.gov ID
- NCT01054326
- Acronym / sponsor ID
- DNR 02-37
- Conditions
- Subacromial Decompression
- Keywords
- arthroscopic subacromial decompression, exercise, physical therapy, rotator cuff, shoulder impingement syndrome, Subacromial impingement after arthroscopic subacromial decompression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Kalmar County Hospital
- Study start
- Jan 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 22 Jan 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 objective of this study was to evaluate and compare two different post-surgical rehabilitation strategies, Rehabilitation supervised by a physical therapist including exercises with progressive early activation of the rotator cuff versus basic home exercises regarding shoulder function, pain, health related quality of life and return to work after arthroscopic subacromial decompression.
Detailed description
Patients scheduled for surgery (arthroscopic subacromial decompression)and in the age 25-65 were offered to participate in the study. After surgery they were randomized to either Supervised Physical therapy with early activation of the rotator cuff (PT-group) or to home exercises (H-group). Patients in the PT group met the physical therapist twice a week for exercises and in between these visits they did their exercises at home daily. The H-group did home exercises daily. Shoulder function and pain(primary outcomes)and health related quality of life, returning to work(secondary outcomes)were assessed before surgery, one week after(baseline), 1,2,3 and 6 months after surgery by an independent physical therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised physical therapy focusing of rotatorcuff exercises | Experimental | Other: ExercisesPatients did specific exercises supervised by a physical therapists twice a week during two months. Focus was on early activation of rotator cuff and scapula stabilizers following different phases in a rehabilitation program Assessments before surgery,1 week after as well as 1,2,3 and 6 months after surgery. |
| Home exercises | Active comparator | Other: ExercisesPatients did home exercises following a programme during three months. Assessment considering shoulder function and pain was done before surgery, 1w after as well as 1,2,3 and 6 months after surgery, |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subacromial impingement verified with Neer impingement test
- At least 6 month duration of pain
- Treated in primary care without satisfactory results for at least three months.
- Typical history and pain location. Scheduled for surgery (subacromial decompression)
- Three of these four tests must be positive:
Key exclusion criteria (5 listed)
- Radiological findings of malignancy osteoarthritis, fractures
- Polyarthritis or fibromyalgia
- Pathological hyper laxity
- Lack of communication skills that prevent the use of outcome measurements
- Cervical spine pathology
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 |
|---|---|---|
| Exercises | Other | Home exercises, Supervised physical therapy focusing of rotatorcuff exercises |
Primary outcome
Shoulder function and pain
Time frame: before surgery, 1 w (baseline, 1,2,3 and 6 month after surgery
1 secondary outcome
Health related quality of life and returning to work
Time frame: before surhery and 1 w(baseline)1,2,3 and 6 months after surgery
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 22 Jan 2010.
Related trials for Subacromial Decompression
Recruiting
The Effect of Arthroscopic Subacromial Decompression in Patients Who Are Non-responders to Non-operative Treatment.
Subacromial Impingement Syndrome
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.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Subacromial Decompression, run by Linkoeping University.
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 8 inclusion and 5 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 22 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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 function and pain (time frame: before surgery, 1 w (baseline, 1,2,3 and 6 month after surgery). 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 22 Jan 2010.