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

Shoulder Impingement Syndrome Clinical Trial

Official title:

Treatment of Subacromial Shoulder Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01441830
• Other study ID #: 2011/5347
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 15, 2011
• Last updated: December 17, 2014
• Start date: September 2011

Study information

• Verified date: December 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Shoulder Pain
• Subacromial Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index (SPADI)		24 weeks	No
Secondary	Health-related quality of life (Eq-5d)		24 weeks and 1 year	No
Secondary	Return to work		6 weeks, 12 weeks, 24 weeks and 1 year	No
Secondary	Pain and function measured on a 11 point Likert type scale		6 weeks, 12 weeks, 24 weeks and 1 year	No