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Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Ullevaal University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
South Eastern Area Health Service
University of Oslo
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00653081
First received: January 7, 2008
Last updated: April 3, 2008
Last verified: January 2007
History of Changes

January 7, 2008
April 3, 2008
July 2006
September 2007   (final data collection date for primary outcome measure)
Shoulder Pain and Disability Index (SPADI) [ Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00653081 on ClinicalTrials.gov Archive Site
Pain intensity labelled "no pain" and "severe pain" at its extremes, are measured on nine point scales for activity and rest during last week. [ Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS
Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study

The purpose of this study is to compare Supervised Exercises with another non-operative frequently used treatment, Radial Extracorporeal Shockwave Therapy (rESWT), for patients with subacromial impingement syndrome.

Shoulder pain is, in succession to back, neck, and knee, the fourth most frequently localized musculoskeletal pain reported by patients to general practitioners and physical therapists. A majority of shoulder complaints lasts for more than three months and become chronic. Few of the different interventions for rehabilitation of chronic shoulder pain, have documented effect. Patients with shoulder pain are associated with significant disability and loss of quality of life which interfere with activities related to daily living.

Supervised exercises, a treatment method which has been compared to surgery and placebo laser, is one that has documented effect for both short (6 months) and long time (2½ years). The purpose of this study was to compare Supervised Exercises with another non-operative common used treatment method for these patients, radial Extracorporeal Shockwave Therapy (rESWT).

The study is designed as a randomised, single blind clinical controlled study.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Shoulder Pain
  • Procedure: Physical therapy method called Supervised Exercises
    Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
  • Procedure: Radial Extracorporeal Shockwave Therapy
    Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
  • Active Comparator: A
    Supervised Exercises performed at ulleval Hospital for patients with shoulder pain. Dosage: 45 minutes each time, max 2-3 times a week in max 12 weeks
    Intervention: Procedure: Physical therapy method called Supervised Exercises
  • Active Comparator: B
    Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
    Intervention: Procedure: Radial Extracorporeal Shockwave Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
104
December 2008
September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subacromial shoulder pain lasting for at least three months and age between 18 and 70 years.
  • Dysfunction or pain on abduction
  • Had a normal passive glenohumeral range of movement
  • Pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º)
  • Positive Hawkins-Kennedys test.

Exclusion Criteria:

  • Shoulder pain bilateral (both shoulders required treatment)
  • Earlier operated in affected shoulder
  • Had multidirectional instability
  • Had the cervical syndrome
  • Rheumatoid arthritis
  • Clinical and radiological findings indicating glenohumeral - or acromioclavicular joint pathology
  • Not able to understand spoken or written Norwegian
  • Considerable emotional distress
  • Needed anticoagulant medicine
  • Being pregnant
  • Had had Shock Wave Therapy or Supervised Exercises before.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00653081
VT, rESWT
Yes
University of Oslo, South Eastern Area Health Service
Ullevaal University Hospital
  • South Eastern Area Health Service
  • University of Oslo
Principal Investigator: Kaia Engebretsen, PhD Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway
Ullevaal University Hospital
January 2007

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