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Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

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ClinicalTrials.gov Identifier: NCT00983177
Recruitment Status : Unknown
Verified July 2010 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
First Posted : September 23, 2009
Last Update Posted : July 20, 2010
Information provided by:
Bnai Zion Medical Center

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.

Condition or disease Intervention/treatment
Calcific Tendonitis Drug: Colchicine Drug: lactose

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis: Double Blind Placebo-controlled Study
Study Start Date : March 2010
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: colchicine Drug: Colchicine
0.5 mg twice daily for 4 months
Placebo Comparator: Lactose capsule Drug: lactose
lactose capsules twice daily

Primary Outcome Measures :
  1. VAS for shoulder pain [ Time Frame: 4-8 months ]
  2. shoulder range of motion [ Time Frame: 4-8 months ]
  3. shoulder pain and disability index [ Time Frame: 4-8 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983177

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

Bnai Zion Medical Center Recruiting
Haifa, Israel
Contact: Gleb Slobodin, MD       gleb.slobodin@b-zion.org.il   
Principal Investigator: Gleb Slobodin, MD         
Sponsors and Collaborators
Bnai Zion Medical Center
Study Director: Itzhak Rosner, MD Bnai Zion Medical Center

Responsible Party: Gleb Slobodin, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT00983177     History of Changes
Other Study ID Numbers: colchicine1
First Posted: September 23, 2009    Key Record Dates
Last Update Posted: July 20, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Tendon Injuries
Wounds and Injuries
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents