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Trial record 1 of 1 for:    nct01441830
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Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain

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ClinicalTrials.gov Identifier: NCT01441830
Recruitment Status : Unknown
Verified December 2014 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2011
Last Update Posted : December 18, 2014
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE September 15, 2011
First Posted Date  ICMJE September 28, 2011
Last Update Posted Date December 18, 2014
Study Start Date  ICMJE September 2011
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2011)
Shoulder Pain and Disability Index (SPADI) [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radial Extracorporeal Shock Wave Therapy (rESWT) Treatment of Subacromial Shoulder Pain
Official Title  ICMJE Treatment of Subacromial Shoulder Pain
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Shoulder Impingement Syndrome
  • Subacromial Shoulder Pain
Intervention  ICMJE 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
Study Arms  ICMJE
  • Sham Comparator: sham rESWT
    Intervention: Device: Radial extracorporeal shock wave therapy
  • Active Comparator: rESWT
    Intervention: Device: Radial extracorporeal shock wave therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 27, 2011)
150
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01441830
Other Study ID Numbers  ICMJE 2011/5347
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oslo University Hospital
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP