We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00653081
Recruitment Status : Unknown
Verified January 2007 by Ullevaal University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 4, 2008
Last Update Posted : April 4, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Procedure: Physical therapy method called Supervised Exercises Procedure: Radial Extracorporeal Shockwave Therapy Phase 3

Detailed Description:

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With Subacromial Impingement Syndrome: A Single Blind Clinical Randomized Study
Study Start Date : July 2006
Primary Completion Date : September 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Procedure: Physical therapy method called Supervised Exercises
Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
Active Comparator: B
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
Procedure: Radial Extracorporeal Shockwave Therapy
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.


Outcome Measures

Primary Outcome Measures :
  1. Shoulder Pain and Disability Index (SPADI) [ Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653081


Locations
Norway
Department for physical medicine and rehabilitation, Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
South Eastern Area Health Service
University of Oslo
Investigators
Principal Investigator: Kaia Engebretsen, PhD Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oslo, South Eastern Area Health Service
ClinicalTrials.gov Identifier: NCT00653081     History of Changes
Other Study ID Numbers: VT
rESWT
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: April 4, 2008
Last Verified: January 2007

Keywords provided by Ullevaal University Hospital:
Shoulder pain
Supervised Exercises
Radial Shock Wave Therapy

Additional relevant MeSH terms:
Shoulder Pain
Shoulder Impingement Syndrome
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Shoulder Injuries
Wounds and Injuries