Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

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

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.

Study Overview

• Status: Unknown
• Conditions: Calcific Tendonitis
• Intervention / Treatment: Drug: Colchicine; Drug: lactose

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VAS for shoulder pain	4-8 months
shoulder range of motion	4-8 months
shoulder pain and disability index	4-8 months

Collaborators and Investigators

• Sponsor: Bnai Zion Medical Center
• Investigators: Study Director: Itzhak Rosner, MD, Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: September 22, 2009
• First Submitted That Met QC Criteria: September 22, 2009
• First Posted (Estimate): September 23, 2009

Study Record Updates

• Last Update Posted (Estimate): July 20, 2010
• Last Update Submitted That Met QC Criteria: July 18, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Arthralgia; Tendinopathy; Shoulder Pain; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: colchicine1