Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified December 2014 by Oslo University Hospital.
Recruitment status was: Active, not recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01441830

First Posted: September 28, 2011

Last Update Posted: December 18, 2014

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Oslo University Hospital

Purpose

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.

Condition	Intervention	Phase
Shoulder Impingement Syndrome Subacromial Shoulder Pain	Device: Radial extracorporeal shock wave therapy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Treatment of Subacromial Shoulder Pain

Resource links provided by NLM:

MedlinePlus related topics: Shock

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:

Shoulder Pain and Disability Index (SPADI) [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	150
Study Start Date:	September 2011
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham Comparator: sham rESWT	Device: Radial extracorporeal 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 Other Names: rESWT ESWT RSWT shock wave therapy
Active Comparator: rESWT	Device: Radial extracorporeal 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 Other Names: rESWT ESWT RSWT shock wave therapy

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	25 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Exclusion criteria cont.
Patients considered unable to fill out questionnaires or to go through the treatment
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441830

Locations


Norway
Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation
Oslo, Norway, 0450

Sponsors and Collaborators

Oslo University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kvalvaag E, Brox JI, Engebretsen KB, Søberg HL, Bautz-Holter E, Røe 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.


Responsible Party:	Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT01441830 History of Changes
Other Study ID Numbers:	2011/5347
First Submitted:	September 15, 2011
First Posted:	September 28, 2011
Last Update Posted:	December 18, 2014
Last Verified:	December 2014

Keywords provided by Oslo University Hospital:


shoulder subacromial impingement tendinopathy	rESWT shock wave ESWT RSWT

Additional relevant MeSH terms:


Shoulder Pain Shoulder Impingement Syndrome Arthralgia Joint Diseases Musculoskeletal Diseases Pain	Neurologic Manifestations Nervous System Diseases Signs and Symptoms Shoulder Injuries Wounds and Injuries

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