Calcific TendonitisNCT00983177
Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis
A study testing Colchicine and lactose in people with Calcific Tendonitis, run by Bnai Zion Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcific Tendonitis
- What is being tested?
- Colchicine and lactose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic, more than 3 months duration, shoulder pain
- tendinous calcifications on shoulder X-rays
Who cannot join
- renal insufficiency
- liver insufficiency
- lactose intolerance
- hypersensitivity to colchicine
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa
Gleb Slobodin, MD, gleb.slobodin@b-zion.org.il
Gleb Slobodin, MD
About this study
Official title: Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis: Double Blind Placebo-controlled Study
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
- Being tested
- Colchicine, lactose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
0.5 mg twice daily for 4 months
lactoseDrug
lactose capsules twice daily
| Study group | Role | What they receive |
|---|---|---|
| colchicine | Active comparator | Not described Receives: Drug: Colchicine |
| Lactose capsule | Placebo comparator | Not described Receives: Drug: lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS for shoulder pain
Measured: 4-8 months
shoulder range of motion
Measured: 4-8 months
shoulder pain and disability index
Measured: 4-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startMar 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcific TendonitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Investigators
- Itzhak Rosner, MD, Study director, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983177
- Sponsor's protocol ID
- colchicine1
- Status last verified
- Jul 2010
- First submitted
- 22 Sep 2009
- Last updated
- 20 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine Treatment for Chronic Shoulder Pain Related to Calcific Tendonitis: Double Blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT00983177
- Acronym / sponsor ID
- colchicine1
- Conditions
- Calcific Tendonitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- Mar 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colchicine | Active comparator | Drug: Colchicine |
| Lactose capsule | Placebo comparator | Drug: lactose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic, more than 3 months duration, shoulder pain
- tendinous calcifications on shoulder X-rays
Key exclusion criteria (4 listed)
- renal insufficiency
- liver insufficiency
- lactose intolerance
- hypersensitivity to colchicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine0.5 mg twice daily for 4 months | Drug | colchicine |
| lactoselactose capsules twice daily | Drug | Lactose capsule |
Primary outcome
VAS for shoulder pain
Time frame: 4-8 months
shoulder range of motion
Time frame: 4-8 months
shoulder pain and disability index
Time frame: 4-8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itzhak Rosner, MD study director
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colchicine and lactose in people with Calcific Tendonitis, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gleb Slobodin, MD (972-506267284, gleb.slobodin@b-zion.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS for shoulder pain (time frame: 4-8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2010.