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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01441830
First received: September 15, 2011
Last updated: December 17, 2014
Last verified: December 2014
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Subacromial Shoulder Pain

Resource links provided by NLM:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life (Eq-5d) [ Time Frame: 24 weeks and 1 year ] [ Designated as safety issue: No ]
  • Return to work [ Time Frame: 6 weeks, 12 weeks, 24 weeks and 1 year ] [ Designated as safety issue: No ]
  • Pain and function measured on a 11 point Likert type scale [ Time Frame: 6 weeks, 12 weeks, 24 weeks and 1 year ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441830

Locations
Norway
Oslo University Hospital, Ulleval, department for physical medicine and rehabilitation
Oslo, Norway, 0450
Sponsors and Collaborators
Oslo University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01441830     History of Changes
Other Study ID Numbers: 2011/5347
Study First Received: September 15, 2011
Last Updated: December 17, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Oslo University Hospital:
shoulder
subacromial
impingement
tendinopathy
 rESWT
shock wave
ESWT
RSWT

Additional relevant MeSH terms:
Shoulder Impingement Syndrome
Shoulder Pain
Arthralgia
Joint Diseases
 Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on February 25, 2015