Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

• Sponsor: Bnai Zion Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00983177
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 4.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Calcific Tendonitis	Drug: Colchicine; Drug: lactose	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis: Double Blind Placebo-controlled Study
• Study Start Date: Mar 1, 2010
• Anticipated Primary Completion Date: Oct 1, 2011
• Anticipated Study Completion Date: Oct 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. VAS for shoulder pain [4-8 months]

2. shoulder range of motion [4-8 months]

3. shoulder pain and disability index [4-8 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bnai Zion Medical Center	Haifa		Israel

Sponsors and Collaborators

• Bnai Zion Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00983177
• Other Study ID Numbers: colchicine1
• First Posted: Sep 23, 2009
• Last Update Posted: Jul 20, 2010
• Last Verified: Jul 1, 2010

• Additional relevant MeSH terms: Shoulder Pain; Tendinopathy; Colchicine

Study Results

No Results Posted as of Jul 20, 2010