Calcific Tendonitis
Conditions
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.
Interventions
DRUGColchicine
0.5 mg twice daily for 4 months
DRUGlactose
lactose capsules twice daily
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| 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 |
Countries
Israel
Contacts
Primary ContactGleb Slobodin, MD
Outcome results
None listed