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Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Bnai Zion Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00983177
First Posted: September 23, 2009
Last Update Posted: July 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bnai Zion Medical Center
  Purpose
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 Intervention
Calcific Tendonitis Drug: Colchicine Drug: lactose

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bnai Zion Medical Center:

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

Estimated Enrollment: 80
Study Start Date: March 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: colchicine Drug: Colchicine
0.5 mg twice daily for 4 months
Placebo Comparator: Lactose capsule Drug: lactose
lactose capsules twice daily

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


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

Locations
Israel
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
Investigators
Study Director: Itzhak Rosner, MD Bnai Zion Medical Center
  More Information

Responsible Party: Gleb Slobodin, Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT00983177     History of Changes
Other Study ID Numbers: colchicine1
First Submitted: September 22, 2009
First Posted: September 23, 2009
Last Update Posted: July 20, 2010
Last Verified: July 2010

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