Shoulder Impingement SyndromePhase 3NCT01441830
Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain
A Phase 3 study testing Radial extracorporeal shock wave therapy in people with Shoulder Impingement Syndrome and Subacromial Shoulder Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine whether rESWT (radial extracorporeal shock wave therapy) combined with supervised exercises will improve function and reduce pain in subacromial shoulder pain compared with supervised exercises alone. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Shoulder Impingement Syndrome, Subacromial Shoulder Pain
- What is being tested?
- Radial extracorporeal shock wave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2011to May 2015
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dysfunction or pain on abduction
- Pain on one of two isometric tests (abduction or external rotation)
- Positive Hawkins sign
- Normal passive glenohumeral range of motion
Who cannot join
- Previous surgery on affected shoulder
- Instability
- Total rupture of the rotator cuff (evaluated clinically or by US)
- Clinical signs of a cervical syndrome
- Infection in the area
- Patients considered unable to fill out questionnaires or to go through the treatment
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- Use of anticoagulant drugs or bleeding disorder
- Pregnancy
- Previous experience of one of the study interventions
- Corticosteroid injection in the past 6 weeks.
- SPADI < 20
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation
Oslo, Oslo, 0450
About this study
Official title: Treatment of Subacromial Shoulder Pain
The purpose of this study is to determine whether rESWT (radial extracorporeal shock wave therapy) combined with supervised exercises will improve function and reduce pain in subacromial shoulder pain compared with supervised exercises alone.
- Being tested
- Radial extracorporeal shock wave therapy
- Keywords
- shoulder, subacromial, impingement, tendinopathy, rESWT, shock wave, ESWT, RSWT
- Medical subject headings
- Shoulder Impingement Syndrome, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial extracorporeal shock wave therapyDevice
Also called rESWT, ESWT, RSWT, shock wave therapy
The shockwave treatment will be administered once a week for four weeks on one to three specific points (supraspinatus, infraspinatus or subscapular tendon)and with a pressure between 1,5-3 Bar
| Study group | Role | What they receive |
|---|---|---|
| sham rESWT | Sham comparator | Not described Receives: Device: Radial extracorporeal shock wave therapy |
| rESWT | Active comparator | Not described Receives: Device: Radial extracorporeal shock wave 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: 24 weeks
Secondary outcomes (3)
Health-related quality of life (Eq-5d)
Measured: 24 weeks and 1 year
Return to work
Measured: 6 weeks, 12 weeks, 24 weeks and 1 year
Pain and function measured on a 11 point Likert type scale
Measured: 6 weeks, 12 weeks, 24 weeks and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2015 (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 Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441830
- Sponsor's protocol ID
- 2011/5347
- Status last verified
- Dec 2014
- First submitted
- 15 Sep 2011
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kvalvaag E, Anvar M, Karlberg AC, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Shoulder MRI features with clinical correlations in subacromial pain syndrome: a cross-sectional and prognostic study. BMC Musculoskelet Disord. 2017 Nov 21;18(1):469. doi: 10.1186/s12891-017-1827-3.
PubMed 29157224Kvalvaag E, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Effectiveness of Radial Extracorporeal Shock Wave Therapy (rESWT) When Combined With Supervised Exercises in Patients With Subacromial Shoulder Pain: A Double-Masked, Randomized, Sham-Controlled Trial. Am J Sports Med. 2017 Sep;45(11):2547-2554. doi: 10.1177/0363546517707505. Epub 2017 Jun 6.
PubMed 28586628Kvalvaag E, Brox JI, Engebretsen KB, Soberg HL, Bautz-Holter E, Roe C. Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial. BMC Musculoskelet Disord. 2015 Sep 11;16:248. doi: 10.1186/s12891-015-0712-1.
PubMed 26361756
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Subacromial Shoulder Pain
- ClinicalTrials.gov ID
- NCT01441830
- Acronym / sponsor ID
- 2011/5347
- Keywords
- shoulder, subacromial, impingement, tendinopathy, rESWT, shock wave, ESWT, RSWT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2015 (estimated)
- First posted
- 28 Sep 2011 (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 determine whether rESWT (radial extracorporeal shock wave therapy) combined with supervised exercises will improve function and reduce pain in subacromial shoulder pain compared with supervised exercises alone.
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 |
|---|---|---|
| sham rESWT | Sham comparator | Device: Radial extracorporeal shock wave therapy |
| rESWT | Active comparator | Device: Radial extracorporeal shock wave therapy |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dysfunction or pain on abduction
- Pain on one of two isometric tests (abduction or external rotation)
- Positive Hawkins sign
- Normal passive glenohumeral range of motion
Key exclusion criteria (11 listed)
- Previous surgery on affected shoulder
- Instability
- Total rupture of the rotator cuff (evaluated clinically or by US)
- Clinical signs of a cervical syndrome
- Infection in the area
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 |
|---|---|---|
| Radial extracorporeal shock wave therapyAlso: rESWT, ESWT, RSWT, shock wave therapyThe shockwave treatment will be administered once a week for four weeks on one to three specific points (supraspinatus, infraspinatus or subscapular tendon)and with a pressure between 1,5-3 Bar | Device | rESWT, sham rESWT |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: 24 weeks
3 secondary outcomes
Health-related quality of life (Eq-5d)
Time frame: 24 weeks and 1 year
Return to work
Time frame: 6 weeks, 12 weeks, 24 weeks and 1 year
Pain and function measured on a 11 point Likert type scale
Time frame: 6 weeks, 12 weeks, 24 weeks and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Derived from this study: PubMed 29157224Kvalvaag E, Anvar M, Karlberg AC, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Shoulder MRI features with clinical correlations in subacromial pain syndrome: a cross-sectional and prognostic study. BMC Musculoskelet Disord. 2017 Nov 21;18(1):469. doi: 10.1186/s12891-017-1827-3.
- Derived from this study: PubMed 28586628Kvalvaag E, Brox JI, Engebretsen KB, Soberg HL, Juel NG, Bautz-Holter E, Sandvik L, Roe C. Effectiveness of Radial Extracorporeal Shock Wave Therapy (rESWT) When Combined With Supervised Exercises in Patients With Subacromial Shoulder Pain: A Double-Masked, Randomized, Sham-Controlled Trial. Am J Sports Med. 2017 Sep;45(11):2547-2554. doi: 10.1177/0363546517707505. Epub 2017 Jun 6.
- Derived from this study: PubMed 26361756Kvalvaag E, Brox JI, Engebretsen KB, Soberg HL, Bautz-Holter E, Roe C. Is radial Extracorporeal Shock Wave Therapy (rEWST) combined with supervised exercises (SE) more effective than sham rESWT and SE in patients with subacromial shoulder pain? Study protocol for a double-blind randomised, sham-controlled trial. BMC Musculoskelet Disord. 2015 Sep 11;16:248. doi: 10.1186/s12891-015-0712-1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Radial extracorporeal shock wave therapy in people with Shoulder Impingement Syndrome and Subacromial Shoulder Pain, run by Oslo 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 4 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 18 Dec 2014. 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. Some participants in this study may receive a placebo. 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: 24 weeks). 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 NCT01441830, 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 18 Dec 2014.