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Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

Information source: Bnai Zion Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Calcific Tendonitis

Intervention: Colchicine (Drug); lactose (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Bnai Zion Medical Center

Official(s) and/or principal investigator(s):
Itzhak Rosner, MD, Study Director, Affiliation: Bnai Zion Medical Center

Overall contact:
Gleb Slobodin, MD, Phone: 972-506267284, Email: gleb.slobodin@b-zion.org.il

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.

Clinical Details

Official title: Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis: Double Blind Placebo-controlled Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

VAS for shoulder pain

shoulder range of motion

shoulder pain and disability index

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Gleb Slobodin, MD, Phone: 972-506267284, Email: gleb.slobodin@b-zion.org.il

Bnai Zion Medical Center, Haifa, Israel; Recruiting
Gleb Slobodin, MD, Email: gleb.slobodin@b-zion.org.il
Gleb Slobodin, MD, Principal Investigator
Additional Information

Starting date: March 2010
Last updated: July 18, 2010

Page last updated: August 20, 2015

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