Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder
Primary Purpose
Shoulder Bursitis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Bursitis focused on measuring Shoulder, Impingement, Ultrasound, injection of glucocorticosteroid, exercise
Eligibility Criteria
Inclusion Criteria:
- Pain and reduced motion in the shoulder for more than four weeks
- Ultrasound verified swollenness of the bursa.
Exclusion Criteria:
- Bilateral pain in the shoulder joints
- Rupture of the rotator cuff or biceps tendons
- Generalised disease which can explain the shoulder pain
- OA in the shoulder joint
- Diabetes
- Positive compression test of the cervical spine
Sites / Locations
- The Parker Institute, Frederiksberg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Training of painful shoulder
Contralateral training
Arm Description
Steroid injection X 2 and 10 weeks exercise program of painful shoulder
Steroid injection X 2 and 10 weeks exercise program of asymptomatic shoulder
Outcomes
Primary Outcome Measures
Pain in the shoulder in both rest and motion (VAS)
Secondary Outcome Measures
Ultrasound
Strength
Clinical impingement
Shoulder function
Full Information
NCT ID
NCT01506804
First Posted
May 5, 2011
Last Updated
August 9, 2016
Sponsor
Frederiksberg University Hospital
Collaborators
Oak Foundation, The Danish Physiotherapy Foundation, Fund for Physiotherapy in Private Practice, Aase and Ejnar Danielsens Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01506804
Brief Title
Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder
Official Title
The Efficacy of Exercise Therapy Followed by Ultrasound Guided Injection in Patients With a Painful Shoulder - a Randomised Controlled Study With Blinded Observer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Frederiksberg University Hospital
Collaborators
Oak Foundation, The Danish Physiotherapy Foundation, Fund for Physiotherapy in Private Practice, Aase and Ejnar Danielsens Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Many patients experience an effect of steroid injection, however the effect is often short lasting and recurrence of symptoms is common. The short term effect of injection has been shown to be much better than exercise therapy; however over time the superior effect of injection compared to exercise does not last. Injection in combination with exercise therapy might be a more sufficient therapy than injection alone. The aim of this study is to investigate a combination of steroid injection and a 10 week exercise program. In addition, the study tests the validity of clinical impingement tests using ultrasound verified impingement as gold standard.
Detailed Description
For many patients unspecific pain and reduced motion in the shoulder is a common complaint. It is believed that the main reason for shoulder pain comes from inflammation of the bursa.
Many patients experience an effect of steroid injection, however the effect is often short lasting and recurrence of symptoms is common. Exercise therapy for the muscles around the shoulder joint is also common treatment for shoulder pain. The short term effect of injection has been shown to be much better than exercise therapy; however over time the superior effect of injection compared to exercise does not last. The anti-inflammatory and pain releasing effect of steroid injection in combination with exercise therapy increasing the strength and control of the muscles around the shoulder joint, might be a more sufficient therapy than injection alone. Thus, the aim of this study is to investigate a combination of steroid injection and a 10 week exercise program in patients with a painful shoulder.
Many different clinical tests are used to examine the pathological compression of the bursa during motion in the shoulder joint (impingement). However, it is actually not known if the pain in motion is caused by compression of the bursa. Part of this study therefore is to test the validity of clinical impingement tests using ultrasound verified impingement as gold standard.
Studies comparing injection given guided by ultrasound to blind injections have shown that the ultrasound guided injections are more likely to place the active stuff correctly in the swollen bursa. In this study all injections will be given ultrasound guided. In the ultrasound examination the thickness of the bursa will be measured in all patients in order to investigate if swollenness of the bursa can explained the pain and dysfunction of the shoulder joint
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Bursitis
Keywords
Shoulder, Impingement, Ultrasound, injection of glucocorticosteroid, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training of painful shoulder
Arm Type
Experimental
Arm Description
Steroid injection X 2 and 10 weeks exercise program of painful shoulder
Arm Title
Contralateral training
Arm Type
Placebo Comparator
Arm Description
Steroid injection X 2 and 10 weeks exercise program of asymptomatic shoulder
Intervention Type
Other
Intervention Name(s)
methylprednisolone
Intervention Description
Steroid injection X 2 and 10 weeks exercise program of painful shoulder vs exercise program of contralateral shoulder
Primary Outcome Measure Information:
Title
Pain in the shoulder in both rest and motion (VAS)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ultrasound
Time Frame
6 months
Title
Strength
Time Frame
6 months
Title
Clinical impingement
Time Frame
6 months
Title
Shoulder function
Time Frame
6 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:
Pain and reduced motion in the shoulder for more than four weeks
Ultrasound verified swollenness of the bursa.
Exclusion Criteria:
Bilateral pain in the shoulder joints
Rupture of the rotator cuff or biceps tendons
Generalised disease which can explain the shoulder pain
OA in the shoulder joint
Diabetes
Positive compression test of the cervical spine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henning Bliddal, Professor
Organizational Affiliation
The Parker Institute, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Parker Institute, Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
27262892
Citation
Ellegaard K, Christensen R, Rosager S, Bartholdy C, Torp-Pedersen S, Bandholm T, Danneskiold-Samsoe B, Bliddal H, Henriksen M. Exercise therapy after ultrasound-guided corticosteroid injections in patients with subacromial pain syndrome: a randomized controlled trial. Arthritis Res Ther. 2016 Jun 4;18(1):129. doi: 10.1186/s13075-016-1002-5.
Results Reference
derived
Links:
URL
http://www.parkerinst.dk
Description
The Parker Institute, Copenhagen
Learn more about this trial
Exercise Therapy and Ultrasound Guided Injections in Painful Shoulder
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