Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

Calcific Tendonitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00983177
• Other study ID #: colchicine1
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2009
• Last updated: July 18, 2010
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: July 2010
• Source: Bnai Zion Medical Center
• Contact: Gleb Slobodin, MD
• Phone: 972-506267284
• Email: gleb.slobodin[@]b-zion.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Calcific Tendonitis
• Shoulder Pain

Intervention

Drug:
• Colchicine
0.5 mg twice daily for 4 months
• lactose
lactose capsules twice daily

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS for shoulder pain		4-8 months	No
Primary	shoulder range of motion		4-8 months	No
Primary	shoulder pain and disability index		4-8 months	No