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

NCT ID: NCT01441830

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Impingement Syndrome Subacromial Shoulder Pain

Keywords

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shoulder subacromial impingement tendinopathy rESWT shock wave ESWT RSWT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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sham rESWT

Group Type SHAM_COMPARATOR

Radial extracorporeal shock wave therapy

Intervention Type DEVICE

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

rESWT

Group Type ACTIVE_COMPARATOR

Radial extracorporeal shock wave therapy

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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rESWT ESWT RSWT shock wave therapy

Eligibility Criteria

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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
* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Oslo, Oslo County, Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 29157224 (View on PubMed)

Kvalvaag 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.

Reference Type DERIVED
PMID: 28586628 (View on PubMed)

Kvalvaag 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.

Reference Type DERIVED
PMID: 26361756 (View on PubMed)

Other Identifiers

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2011/5347

Identifier Type: -

Identifier Source: org_study_id