Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis

NCT00983177 | Unknown

• 1 other identifier: colchicine1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Calcific Tendonitis

Outcome Measures

Primary Outcomes (3)

• VAS for shoulder pain

  4-8 months

• shoulder range of motion

  4-8 months

• shoulder pain and disability index

  4-8 months

Study Arms (2)

colchicine

ACTIVE COMPARATOR

Drug: Colchicine

Lactose capsule

PLACEBO COMPARATOR

Drug: lactose

Interventions

Colchicine DRUG

0.5 mg twice daily for 4 months

colchicine

lactose DRUG

lactose capsules twice daily

Lactose capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic, more than 3 months duration, shoulder pain
• tendinous calcifications on shoulder X-rays

You may not qualify if:

• renal insufficiency
• liver insufficiency
• lactose intolerance
• hypersensitivity to colchicine

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Interventions

Colchicine; Lactose

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Itzhak Rosner, MD

  Bnai Zion Medical Center

  STUDY DIRECTOR

Central Study Contacts

Gleb Slobodin, MD

CONTACT

972-506267284; gleb.slobodin@b-zion.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: March 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 20, 2010

Record last verified: 2010-07

Locations

IL (1)