TendinitisPhase 2NCT00506038
Efficacy Study of Fine Needle Technique on Calcific Tendinitis
A Phase 2 study testing fine needle technique in people with Tendinitis, run by Hadassah Medical Organization.
Trial summary
Background: Calcific tendinitis of the rotator cuff may cause chronic pain at the shoulder. Sometimes the pain can lead to a serious impairment in the daily life. One of the most efficient treatments is percutaneous needle aspiration using ultrasound guidance. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tendinitis
- What is being tested?
- fine needle technique
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above.
- 6 months of pain in the shoulder.
- Positive IMPING and sensitivity on SST.
- Calcification above 1 cm in one of the dimensions by US or aray of the shoulder.
- Completed conservative treatment: physiotherapy or analgesics.
Who cannot join
- Diabetes, Nephrological diseases
- RC tear according to US.
- Prior operation in this shoulder
- Steroids injection in the last three months.
- A patient that is in the absorption phase of the tendinitis
- Pregnancy
- Coagulation System impairments
About this study
Official title: Phase 2 Study of the Fine Needle Technique on Calcific Tendinitis
Background: Calcific tendinitis of the rotator cuff may cause chronic pain at the shoulder. Sometimes the pain can lead to a serious impairment in the daily life.
One of the most efficient treatments is percutaneous needle aspiration using ultrasound guidance.
Read more
This treatment includes identification the tendonitis with US or screening , local anesthesia and then puncturing the calcium in the rotator cuff many times. The treatment is short 5-10 minutes, relatively cheap ,safe and usually with good outcomes. However in the literature there is a lack of controlled prospective trials.
Our goal is to set a study that will evaluate this treatment between two groups:
- Puncturing the calcium in the rotator cuff 15 times (the experiment group)
- Puncturing the calcium in the rotator cuff twice (the controlled group)
- Conditions
- Tendinitis
- Being tested
- fine needle technique
- Keywords
- Calcific Tendinitis
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fine needle techniqueProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinitisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Ori Safran, MD, Principal investigator, Hadassah Medical OrganizationCharles Milgrom, Prof., Study chair, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00506038
- Sponsor's protocol ID
- SAF01-HMO-CTIL
- Status last verified
- Nov 2008
- First submitted
- 24 Jul 2007
- Last updated
- 23 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Fine Needle Technique on Calcific Tendinitis
- ClinicalTrials.gov ID
- NCT00506038
- Acronym / sponsor ID
- SAF01-HMO-CTIL
- Conditions
- Tendinitis
- Keywords
- Calcific Tendinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 25 Jul 2007 (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.
Background: Calcific tendinitis of the rotator cuff may cause chronic pain at the shoulder. Sometimes the pain can lead to a serious impairment in the daily life.
One of the most efficient treatments is percutaneous needle aspiration using ultrasound guidance.
This treatment includes identification the tendonitis with US or screening , local anesthesia and then puncturing the calcium in the rotator cuff many times. The treatment is short 5-10 minutes, relatively cheap ,safe and usually with good outcomes. However in the literature there is a lack of controlled prospective trials.
Our goal is to set a study that will evaluate this treatment between two groups:
- Puncturing the calcium in the rotator cuff 15 times (the experiment group)
- Puncturing the calcium in the rotator cuff twice (the controlled group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and above.
- 6 months of pain in the shoulder.
- Positive IMPING and sensitivity on SST.
- Calcification above 1 cm in one of the dimensions by US or aray of the shoulder.
- Completed conservative treatment: physiotherapy or analgesics.
Key exclusion criteria (7 listed)
- Diabetes, Nephrological diseases
- RC tear according to US.
- Prior operation in this shoulder
- Steroids injection in the last three months.
- A patient that is in the absorption phase of the tendinitis
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 |
|---|---|---|
| fine needle technique | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
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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.
Ori Safran, MD principal investigator
Hadassah Medical Organization
Charles Milgrom, Prof. study chair
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fine needle technique in people with Tendinitis, run by Hadassah Medical Organization.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 23 Jun 2009.