Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis
Primary Purpose
Calcific Tendonitis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Colchicine
lactose
Sponsored by
About this trial
This is an interventional treatment trial for Calcific Tendonitis
Eligibility Criteria
Inclusion Criteria:
- chronic, more than 3 months duration, shoulder pain
- tendinous calcifications on shoulder X-rays
Exclusion Criteria:
- renal insufficiency
- liver insufficiency
- lactose intolerance
- hypersensitivity to colchicine
Sites / Locations
- Bnai Zion Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
colchicine
Lactose capsule
Arm Description
Outcomes
Primary Outcome Measures
VAS for shoulder pain
shoulder range of motion
shoulder pain and disability index
Secondary Outcome Measures
Full Information
NCT ID
NCT00983177
First Posted
September 22, 2009
Last Updated
July 18, 2010
Sponsor
Bnai Zion Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00983177
Brief Title
Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis
Official Title
Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis: Double Blind Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bnai Zion Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Chronic pain due to calcific tendonitis of shoulder is a prevalent condition usually treated with recurrent courses of NSAIDs, physical therapy or surgical interventions. Colchicine has been reported to be effective in the acute attack of shoulder tendonitis, however, has never been examined in controlled study in patients with chronic shoulder pain secondary to calcific tendonitis. Eighty patients with chronic shoulder pain (at least 3 months duration) due to calcific tendonitis will be randomized to receive colchicine 0.5 mg twice daily or placebo (lactose capsules) for 4 months. At the end of this blinded part of the study, patients who received placebo and did not improve, will be eligible to continue study in the open mode for additional 4 months with study drug. Efficacy (VAS for shoulder pain, shoulder range of motion and shoulder pain and disability index) and safety (blood tests) follow-ups will be scheduled bi-monthly for all patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcific Tendonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
colchicine
Arm Type
Active Comparator
Arm Title
Lactose capsule
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
0.5 mg twice daily for 4 months
Intervention Type
Drug
Intervention Name(s)
lactose
Intervention Description
lactose capsules twice daily
Primary Outcome Measure Information:
Title
VAS for shoulder pain
Time Frame
4-8 months
Title
shoulder range of motion
Time Frame
4-8 months
Title
shoulder pain and disability index
Time Frame
4-8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic, more than 3 months duration, shoulder pain
tendinous calcifications on shoulder X-rays
Exclusion Criteria:
renal insufficiency
liver insufficiency
lactose intolerance
hypersensitivity to colchicine
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gleb Slobodin, MD
Phone
972-506267284
Email
gleb.slobodin@b-zion.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itzhak Rosner, MD
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gleb Slobodin, MD
Email
gleb.slobodin@b-zion.org.il
First Name & Middle Initial & Last Name & Degree
Gleb Slobodin, MD
12. IPD Sharing Statement
Learn more about this trial
Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis
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