Subacromial Impingement SyndromeNCT01037673
Subacromial Impingement - The Need of Arthroscopic Subacromial Decompression After Eccentric Physical Therapy Exercises
A study testing Exercise program and Movement exercises in people with Subacromial Impingement Syndrome, run by Linkoeping University at 1 site in Sweden.
Trial summary
Objective: A randomized clinical trial in order to evaluate the efficacy of structured eccentric exercises tutored by a physical therapist (PT) for patients with subacromial impingement. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Exercise program and Movement exercises
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Jun 2011
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subacromial impingement verified with Neer impingement injection test
- At least 6 months duration
- Treated in primary care without satisfactory result for at least 6 months
- Three of these five must be positive:
- Neer impingement sign
- Hawkins-Kennedy impingement sign
Show all 9Show fewer
- Jobe supraspinatus test
- Patte maneuver
- Typical history and pain location (C5 dermatome)
Who cannot join
- Radiological finding of malignancy, osteoarthritis, fractures
- Polyarthritis or fibromyalgia
- Pathological hyper-laxity or dislocation of the any of the shoulder joints
- Cervical spine pathology
- Lack of communication skills that prevent the use of outcome measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Need of Arthroscopic Subacromial Decompression Change After Eccentric Physical Therapy Exercises in Patients With Subacromial Pain? - A Randomized Clinical Trial
Objective:
A randomized clinical trial in order to evaluate the efficacy of structured eccentric exercises tutored by a physical therapist (PT) for patients with subacromial impingement.
Read more
Hypothesis:
H1 The exercises has a satisfactory effect and the need of an arthroscopic subacromial decompression can be reconsidered.
H0 No difference between the two exercises (experimental and active control) and the patients still need surgery
Further the study objective is to evaluate predictors for a positive or negative treatment response after three months of rehabilitation as well as after 12 months.
Method:
Patients referred to the orthopedic unit for an arthroscopic subacromial decompression, are offered a three month rehabilitation program during the waiting time for surgery which is approximately 4-6 months. All patients must have tried conservative treatments for at least 6 months in primary care with unsatisfactory results. The patients will be randomized to either the structured eccentric exercises tutored by a physical therapist or control exercises with general movements for the neck and shoulders. All patients has an equal number of sessions with the PT to offer similar attention. After three months the following key-question has to be answered: due to your current experience of your shoulder problems do you still need this surgical intervention? A blinded orthopedic surgeon evaluates the following outcomes at baseline and after three and twelve months. Primary outcomes: Constant-Murley shoulder assessment, Disabilities of the Arm Shoulder and Hans and different aspects of pain. Secondary outcomes; EQ-5D, sick-leave and return to work. All patients are evaluated with a diagnostic ultrasound in order to reveal the condition of the rotator cuff. Also long-term results in those who go thorough with the surgery and those who decline will be assessed after 12 months.
Importance of the study results:
Since there is no consensus about which intervention that should be preferred for patients with subacromial impingement the results of the current study is warranted. If this exercise program is successful it can be implemented into clinical practice. Further, clinical characteristics of patients that really need an arthroscopic subacromial decompression can be identified.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Exercise program, Movement exercises
- 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.
Exercise programProcedure or surgery
Also called Eccentric, Rotator cuff, Exercises, Scapular stabilization
A progressive program where load and complexity increases during a 3 month period. Initially PT-tutored every week and then every other week.
Movement exercisesProcedure or surgery
Also called Exercises, posture
A program with the same movements to maintain flexibility in the neck and shoulder. Initially PT-tutored every week and then every other week.
| Study group | Role | What they receive |
|---|---|---|
| PT progressive exercises | Experimental | A progressive program of movement and strength exercises for the rotator cuff and scapular muscles combined with mobilisation of the joint capsule when needed Receives: Procedure: Exercise program |
| Movement exercises neck and shoulder | Active comparator | General movements for the neck and shoulder, Receives: Procedure: Exercise program; Procedure: Movement exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant-Murley shoulder assessment
Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength.
The score is summarized to a maximum of 100 for best available shoulder function.
Measured: Baseline and change after three months of exercises, 3 month follow-up
Constant_Murley shoulder assessment
Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength.
The score is summarized to a maximum of 100 for best available shoulder function.
Measured: Change from baseline to the 12-month follow-up
Secondary outcomes (2)
Health Related Quality of Life by EuroQol 5 dimensions
Measures different items related to heath related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It results in a health-state where an index of 1 is optimal.
Measured: Baseline and change aftert three months of exercises
Health Related Quality of Life by EuroQol 5 dimensions
Measures different items related to heath related quality of life: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. It results in a health-state where an index of 1 is optimal.
Measured: Change from baseline to the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startJan 2008
- Primary completionMar 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement SyndromeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Investigators
- Kajsa Johansson, PhD, RPT, Study chair, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037673
- Sponsor's protocol ID
- 88201401
- Status last verified
- Dec 2009
- First submitted
- 22 Dec 2009
- Last updated
- 17 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Holmgren T, Hallgren HB, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. Br J Sports Med. 2014 Oct;48(19):1456-7. doi: 10.1136/bjsports-2014-e787rep.
PubMed 25213604Hallgren HC, Holmgren T, Oberg B, Johansson K, Adolfsson LE. A specific exercise strategy reduced the need for surgery in subacromial pain patients. Br J Sports Med. 2014 Oct;48(19):1431-6. doi: 10.1136/bjsports-2013-093233. Epub 2014 Jun 26.
PubMed 24970843Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.
PubMed 22349588
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Need of Arthroscopic Subacromial Decompression Change After Eccentric Physical Therapy Exercises in Patients With Subacromial Pain? - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01037673
- Acronym / sponsor ID
- 88201401
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- Jan 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Dec 2009 (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.
Objective:
A randomized clinical trial in order to evaluate the efficacy of structured eccentric exercises tutored by a physical therapist (PT) for patients with subacromial impingement.
Hypothesis:
H1 The exercises has a satisfactory effect and the need of an arthroscopic subacromial decompression can be reconsidered.
H0 No difference between the two exercises (experimental and active control) and the patients still need surgery
Further the study objective is to evaluate predictors for a positive or negative treatment response after three months of rehabilitation as well as after 12 months.
Method:
Patients referred to the orthopedic unit for an arthroscopic subacromial decompression, are offered a three month rehabilitation program during the waiting time for surgery which is approximately 4-6 months. All patients must have tried conservative treatments for at least 6 months in primary care with unsatisfactory results. The patients will be randomized to either the structured eccentric exercises tutored by a physical therapist or control exercises with general movements for the neck and shoulders. All patients has an equal number of sessions with the PT to offer similar attention. After three months the following key-question has to be answered: due to your current experience of your shoulder problems do you still need this surgical intervention? A blinded orthopedic surgeon evaluates the following outcomes at baseline and after three and twelve months. Primary outcomes: Constant-Murley shoulder assessment, Disabilities of the Arm Shoulder and Hans and different aspects of pain. Secondary outcomes; EQ-5D, sick-leave and return to work. All patients are evaluated with a diagnostic ultrasound in order to reveal the condition of the rotator cuff. Also long-term results in those who go thorough with the surgery and those who decline will be assessed after 12 months.
Importance of the study results:
Since there is no consensus about which intervention that should be preferred for patients with subacromial impingement the results of the current study is warranted. If this exercise program is successful it can be implemented into clinical practice. Further, clinical characteristics of patients that really need an arthroscopic subacromial decompression can be identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PT progressive exercises | Experimental | Procedure: Exercise programA progressive program of movement and strength exercises for the rotator cuff and scapular muscles combined with mobilisation of the joint capsule when needed |
| Movement exercises neck and shoulder | Active comparator | Procedure: Exercise program, Procedure: Movement exercisesGeneral movements for the neck and shoulder, |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subacromial impingement verified with Neer impingement injection test
- At least 6 months duration
- Treated in primary care without satisfactory result for at least 6 months
- Neer impingement sign
- Hawkins-Kennedy impingement sign
Key exclusion criteria (5 listed)
- Radiological finding of malignancy, osteoarthritis, fractures
- Polyarthritis or fibromyalgia
- Pathological hyper-laxity or dislocation of the any of the shoulder joints
- Cervical spine pathology
- Lack of communication skills that prevent the use of outcome measures
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 |
|---|---|---|
| Exercise programAlso: Eccentric, Rotator cuff, Exercises, Scapular stabilizationA progressive program where load and complexity increases during a 3 month period. Initially PT-tutored every week and then every other week. | Procedure or surgery | Movement exercises neck and shoulder, PT progressive exercises |
| Movement exercisesAlso: Exercises, postureA program with the same movements to maintain flexibility in the neck and shoulder. Initially PT-tutored every week and then every other week. | Procedure or surgery | Movement exercises neck and shoulder |
Primary outcome
Constant-Murley shoulder assessment
Time frame: Baseline and change after three months of exercises, 3 month follow-up
Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength. The score is summarized to a maximum of 100 for best available shoulder function.
Constant_Murley shoulder assessment
Time frame: Change from baseline to the 12-month follow-up
Measure a combination of self assessed and clinician assessed items; pain, range-of-motion (flexion and abduction), functional positions (hand in neck as well as hand in back), abduction strength. The score is summarized to a maximum of 100 for best available shoulder function.
2 secondary outcomes
Health Related Quality of Life by EuroQol 5 dimensions
Time frame: Baseline and change aftert three months of exercises
Health Related Quality of Life by EuroQol 5 dimensions
Time frame: Change from baseline to the 12-month follow-up
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 Jun 2011.
- Derived from this study: PubMed 25213604Holmgren T, Hallgren HB, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. Br J Sports Med. 2014 Oct;48(19):1456-7. doi: 10.1136/bjsports-2014-e787rep.
- Derived from this study: PubMed 24970843Hallgren HC, Holmgren T, Oberg B, Johansson K, Adolfsson LE. A specific exercise strategy reduced the need for surgery in subacromial pain patients. Br J Sports Med. 2014 Oct;48(19):1431-6. doi: 10.1136/bjsports-2013-093233. Epub 2014 Jun 26.
- Derived from this study: PubMed 22349588Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.
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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.
Kajsa Johansson, PhD, RPT study chair
Linkoeping 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 Exercise program and Movement exercises in people with Subacromial Impingement Syndrome, run by Linkoeping University at 1 site in Sweden.
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 9 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 17 Jun 2011. 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 Sweden. 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?
Constant-Murley shoulder assessment (time frame: Baseline and change after three months of exercises, 3 month follow-up). The study lists 2 primary outcomes in all. 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 NCT01037673, which also lists 3 linked publications.
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 Jun 2011.