Shoulder PainPhase 3NCT00653081
Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS
A Phase 3 study testing Physical therapy method called Supervised Exercises and Radial Extracorporeal Shockwave Therapy in people with Shoulder Pain, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Physical therapy method called Supervised Exercises and Radial Extracorporeal Shockwave Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2006to Dec 2008
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subacromial shoulder pain lasting for at least three months and age between 18 and 70 years.
- Dysfunction or pain on abduction
- Had a normal passive glenohumeral range of movement
- Pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º)
- Positive Hawkins-Kennedys test.
Who cannot join
- Shoulder pain bilateral (both shoulders required treatment)
- Earlier operated in affected shoulder
- Had multidirectional instability
- Had the cervical syndrome
- Rheumatoid arthritis
- Clinical and radiological findings indicating glenohumeral - or acromioclavicular joint pathology
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- Not able to understand spoken or written Norwegian
- Considerable emotional distress
- Needed anticoagulant medicine
- Being pregnant
- Had had Shock Wave Therapy or Supervised Exercises before.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department for physical medicine and rehabilitation, Ullevaal University Hospital
Oslo, Oslo, 0407
About this study
Official title: Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
The purpose of this study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome.
Read the detailed description
Shoulder pain is, in succession to back, neck, and knee, the fourth most frequently localized musculoskeletal pain reported by patients to general practitioners and physical therapists. A majority of shoulder complaints lasts for more than three months and become chronic. Few of the different interventions for rehabilitation of chronic shoulder pain, have documented effect. Patients with shoulder pain are associated with significant disability and loss of quality of life which interfere with activities related to daily living.
Supervised exercises, a treatment method which has been compared to surgery and placebo laser, is one that has documented effect for both short (6 months) and long time (2½ years). The purpose of this study was to compare Supervised Exercises with another non-operative common used treatment method for these patients, radial Extracorporeal Shockwave Therapy (rESWT).
The study is designed as a randomised, single blind clinical controlled study.
- Conditions
- Shoulder Pain
- Being tested
- Physical therapy method called Supervised Exercises, Radial Extracorporeal Shockwave Therapy
- Keywords
- Shoulder pain, Supervised Exercises, Radial Shock Wave Therapy
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy method called Supervised ExercisesProcedure or surgery
Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
Radial Extracorporeal Shockwave TherapyProcedure or surgery
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Supervised Exercises performed at ulleval Hospital for patients with shoulder pain. Dosage: 45 minutes each time, max 2-3 times a week in max 12 weeks Receives: Procedure: Physical therapy method called Supervised Exercises |
| B | Active comparator | Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time. Receives: Procedure: Radial Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI)
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
Secondary outcomes (1)
Pain intensity labelled "no pain" and "severe pain" at its extremes, are measured on nine point scales for activity and rest during last week.
Measured: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startJul 2006
- Primary completionSep 2007
- Study completionDec 2008 (estimated)
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 Shoulder PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South Eastern Area Health Service, University of Oslo
- Investigators
- Kaia Engebretsen, PhD, Principal investigator, Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653081
- Sponsor's protocol ID
- VT
- Other IDs
- rESWT
- Status last verified
- Jan 2007
- First submitted
- 7 Jan 2008
- Last updated
- 4 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Juel NG, Brox JI. Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial. Phys Ther. 2011 Jan;91(1):37-47. doi: 10.2522/ptj.20090338. Epub 2010 Nov 18.
PubMed 21088117Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Brox JI. Predictors of shoulder pain and disability index (SPADI) and work status after 1 year in patients with subacromial shoulder pain. BMC Musculoskelet Disord. 2010 Sep 23;11:218. doi: 10.1186/1471-2474-11-218.
PubMed 20863369Engebretsen K, Grotle M, Bautz-Holter E, Sandvik L, Juel NG, Ekeberg OM, Brox JI. Radial extracorporeal shockwave treatment compared with supervised exercises in patients with subacromial pain syndrome: single blind randomised study. BMJ. 2009 Sep 15;339:b3360. doi: 10.1136/bmj.b3360.
PubMed 19755551
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
- ClinicalTrials.gov ID
- NCT00653081
- Acronym / sponsor ID
- VT
- Conditions
- Shoulder Pain
- Keywords
- Shoulder pain, Supervised Exercises, Radial Shock Wave Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- South Eastern Area Health Service, University of Oslo
- Study start
- Jul 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Dec 2008 (estimated)
- First posted
- 4 Apr 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 study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome.
Detailed description
Shoulder pain is, in succession to back, neck, and knee, the fourth most frequently localized musculoskeletal pain reported by patients to general practitioners and physical therapists. A majority of shoulder complaints lasts for more than three months and become chronic. Few of the different interventions for rehabilitation of chronic shoulder pain, have documented effect. Patients with shoulder pain are associated with significant disability and loss of quality of life which interfere with activities related to daily living.
Supervised exercises, a treatment method which has been compared to surgery and placebo laser, is one that has documented effect for both short (6 months) and long time (2½ years). The purpose of this study was to compare Supervised Exercises with another non-operative common used treatment method for these patients, radial Extracorporeal Shockwave Therapy (rESWT).
The study is designed as a randomised, single blind clinical controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Physical therapy method called Supervised ExercisesSupervised Exercises performed at ulleval Hospital for patients with shoulder pain. Dosage: 45 minutes each time, max 2-3 times a week in max 12 weeks |
| B | Active comparator | Procedure: Radial Extracorporeal Shockwave TherapyRadial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subacromial shoulder pain lasting for at least three months and age between 18 and 70 years.
- Dysfunction or pain on abduction
- Had a normal passive glenohumeral range of movement
- Pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º)
- Positive Hawkins-Kennedys test.
Key exclusion criteria (11 listed)
- Shoulder pain bilateral (both shoulders required treatment)
- Earlier operated in affected shoulder
- Had multidirectional instability
- Had the cervical syndrome
- Rheumatoid arthritis
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 |
|---|---|---|
| Physical therapy method called Supervised ExercisesPerformed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks | Procedure or surgery | A |
| Radial Extracorporeal Shockwave TherapyRadial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time. | Procedure or surgery | B |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
1 secondary outcome
Pain intensity labelled "no pain" and "severe pain" at its extremes, are measured on nine point scales for activity and rest during last week.
Time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2008.
- Derived from this study: PubMed 21088117Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Juel NG, Brox JI. Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial. Phys Ther. 2011 Jan;91(1):37-47. doi: 10.2522/ptj.20090338. Epub 2010 Nov 18.
- Derived from this study: PubMed 20863369Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Brox JI. Predictors of shoulder pain and disability index (SPADI) and work status after 1 year in patients with subacromial shoulder pain. BMC Musculoskelet Disord. 2010 Sep 23;11:218. doi: 10.1186/1471-2474-11-218.
- Derived from this study: PubMed 19755551Engebretsen K, Grotle M, Bautz-Holter E, Sandvik L, Juel NG, Ekeberg OM, Brox JI. Radial extracorporeal shockwave treatment compared with supervised exercises in patients with subacromial pain syndrome: single blind randomised study. BMJ. 2009 Sep 15;339:b3360. doi: 10.1136/bmj.b3360.
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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.
Kaia Engebretsen, PhD principal investigator
Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Physical therapy method called Supervised Exercises and Radial Extracorporeal Shockwave Therapy in people with Shoulder Pain, run by Ullevaal University Hospital at 1 site in Norway.
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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 4 Apr 2008. 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 Norway. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 Pain and Disability Index (SPADI) (time frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 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 NCT00653081, 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 4 Apr 2008.