Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

Bnai Zion Medical Center

Status: Unknown

Conditions: Calcific Tendonitis

Treatments: Drug: Colchicine; Drug: lactose

Study type: Interventional

Funder types: Other

Identifiers

NCT00983177

colchicine1

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

colchicine

Active Comparator group

Treatment:

Drug: Colchicine

Lactose capsule

Placebo Comparator group

Treatment:

Drug: lactose