Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

Last updated: July 18, 2010
Sponsor: Bnai Zion Medical Center
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Sprains

Tendon Injuries

Treatment

N/A

Clinical Study ID

NCT00983177
colchicine1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • chronic, more than 3 months duration, shoulder pain

  • tendinous calcifications on shoulder X-rays

Exclusion

Exclusion Criteria:

  • renal insufficiency

  • liver insufficiency

  • lactose intolerance

  • hypersensitivity to colchicine

Study Design

Total Participants: 80
Study Start date:
March 01, 2010
Estimated Completion Date:
October 31, 2011

Connect with a study center

  • Bnai Zion Medical Center

    Haifa,
    Israel

    Active - Recruiting

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