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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Withdrawn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
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

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

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 17, 2009
Last Updated
June 21, 2015
Sponsor
HaEmek Medical Center, Israel
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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Withdrawn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

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Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder

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