search
Back to results

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

Primary Purpose

Shoulder Pain

Status
Unknown status
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Physical therapy method called Supervised Exercises
Radial Extracorporeal Shockwave Therapy
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder pain, Supervised Exercises, Radial Shock Wave Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department for physical medicine and rehabilitation, Ullevaal University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

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

Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.

Outcomes

Primary Outcome Measures

Shoulder Pain and Disability Index (SPADI)

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.

Full Information

First Posted
January 7, 2008
Last Updated
April 3, 2008
Sponsor
Ullevaal University Hospital
Collaborators
South Eastern Area Health Service, University of Oslo
search

1. Study Identification

Unique Protocol Identification Number
NCT00653081
Brief Title
Supervised Exercises Compared With Radial Extracorporal Shock Wave Therapy (rESWT) in Patients With SIS
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 Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ullevaal University Hospital
Collaborators
South Eastern Area Health Service, University of Oslo

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Shoulder pain, Supervised Exercises, Radial Shock Wave Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
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
Arm Title
B
Arm Type
Active Comparator
Arm Description
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
Intervention Type
Procedure
Intervention Name(s)
Physical therapy method called Supervised Exercises
Intervention Description
Performed at ullevaal Hospital, 45 min each time, 2-3 times pr week in max 12 weeks
Intervention Type
Procedure
Intervention Name(s)
Radial Extracorporeal Shockwave Therapy
Intervention Description
Radial Shock Wave therapy performed at ulleval Hospital, once a week, 4-6 times, 3-5 points each time.
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI)
Time Frame
Baseline, 6 weeks, 12 weeks, 18 weeks and 12 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaia Engebretsen, PhD
Organizational Affiliation
Dep of Physical Medicine and rehabilitation, Ullevaal University Hospital, Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for physical medicine and rehabilitation, Ullevaal University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
21088117
Citation
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.
Results Reference
derived
PubMed Identifier
20863369
Citation
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.
Results Reference
derived
PubMed Identifier
19755551
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs