Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder
Primary Purpose
Tendonitis, Bursitis
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Betamethasone Sodium Phosphate
1 cc - Betamethasone Sodium Phosphate
2 cc - Betamethasone Sodium Phosphate
Sponsored by
About this trial
This is an interventional treatment trial for Tendonitis focused on measuring shoulder, subacromion, corticosteroid, bursitis, tendinitis, calcific tendonitis, subacromial bursitis, rotator cuff tendinitis
Eligibility Criteria
Inclusion Criteria:
- subacromial bursitis
- tendinitis
- Calcific Tendonitis
Exclusion Criteria:
- rotator cuff tear
- osteoarthritis
- pregnancy
- local or systemic infection
- steroid or lidocaine sensitivity
Sites / Locations
- Haemek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1 cc - Betamethasone Sodium Phosphate
2 cc - Betamethasone Sodium Phosphate
Arm Description
1 cc - Betamethasone Sodium Phosphate
2 cc - Betamethasone Sodium Phosphate
Outcomes
Primary Outcome Measures
constant score
Secondary Outcome Measures
Full Information
NCT ID
NCT00914836
First Posted
May 17, 2009
Last Updated
June 21, 2015
Sponsor
HaEmek Medical Center, Israel
1. Study Identification
Unique Protocol Identification Number
NCT00914836
Brief Title
Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
difficulties in the department
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
HaEmek Medical Center, Israel
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The use of corticosteroid subacromial injections have been found to be effective for the treatment of shoulder pain. Higher doses may be better than lower doses for subacromial corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to compare 2 doses of corticosteroids.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendonitis, Bursitis
Keywords
shoulder, subacromion, corticosteroid, bursitis, tendinitis, calcific tendonitis, subacromial bursitis, rotator cuff tendinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 cc - Betamethasone Sodium Phosphate
Arm Type
Active Comparator
Arm Description
1 cc - Betamethasone Sodium Phosphate
Arm Title
2 cc - Betamethasone Sodium Phosphate
Arm Type
Active Comparator
Arm Description
2 cc - Betamethasone Sodium Phosphate
Intervention Type
Drug
Intervention Name(s)
Betamethasone Sodium Phosphate
Other Intervention Name(s)
diprospan
Intervention Description
1cc:2cc
Intervention Type
Drug
Intervention Name(s)
1 cc - Betamethasone Sodium Phosphate
Other Intervention Name(s)
diprospan
Intervention Description
Betamethasone Sodium Phosphate
Intervention Type
Drug
Intervention Name(s)
2 cc - Betamethasone Sodium Phosphate
Other Intervention Name(s)
diprospan
Intervention Description
Betamethasone Sodium Phosphate
Primary Outcome Measure Information:
Title
constant score
Time Frame
9 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subacromial bursitis
tendinitis
Calcific Tendonitis
Exclusion Criteria:
rotator cuff tear
osteoarthritis
pregnancy
local or systemic infection
steroid or lidocaine sensitivity
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
8762750
Citation
van der Heijden GJ, van der Windt DA, Kleijnen J, Koes BW, Bouter LM. Steroid injections for shoulder disorders: a systematic review of randomized clinical trials. Br J Gen Pract. 1996 May;46(406):309-16.
Results Reference
background
Learn more about this trial
Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder
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