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

Purpose

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	Intervention	Phase
Shoulder Pain	Procedure: Physical therapy method called Supervised Exercises Procedure: Radial Extracorporeal Shockwave Therapy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Shock

U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:

Shoulder Pain and Disability Index (SPADI) [ Time Frame: Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Enrollment:	104
Study Start Date:	July 2006
Estimated Study Completion Date:	December 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

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: 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):

Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Juel NG, Brox JI. Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial. Phys Ther. 2011 Jan;91(1):37-47. doi: 10.2522/ptj.20090338. Epub 2010 Nov 18.

Engebretsen K, Grotle M, Bautz-Holter E, Ekeberg OM, Brox JI. Predictors of shoulder pain and disability index (SPADI) and work status after 1 year in patients with subacromial shoulder pain. BMC Musculoskelet Disord. 2010 Sep 23;11:218. doi: 10.1186/1471-2474-11-218.

Engebretsen K, Grotle M, Bautz-Holter E, Sandvik L, Juel NG, Ekeberg OM, Brox JI. Radial extracorporeal shockwave treatment compared with supervised exercises in patients with subacromial pain syndrome: single blind randomised study. BMJ. 2009 Sep 15;339:b3360. doi: 10.1136/bmj.b3360.


Responsible Party:	University of Oslo, South Eastern Area Health Service
ClinicalTrials.gov Identifier:	NCT00653081 History of Changes
Other Study ID Numbers:	VT rESWT
Study First Received:	January 7, 2008
Last Updated:	April 3, 2008
Health Authority:	Norway:National Committee for Medical and Health Research Ethics Norway: Data Protection Authority

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

ClinicalTrials.gov processed this record on September 29, 2016

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