Efficacy Study of Fine Needle Technique on Calcific Tendinitis

Hadassah Medical Center

Status and phase: Terminated; Phase 2

Conditions: Tendinitis

Treatments: Procedure: fine needle technique

Study type: Interventional

Funder types: Other

Identifiers

NCT00506038

SAF01-HMO-CTIL

Details and patient eligibility

About

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:

1. Puncturing the calcium in the rotator cuff 15 times (the experiment group)
2. Puncturing the calcium in the rotator cuff twice (the controlled group)

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 and above.
2. 6 months of pain in the shoulder.
3. Positive IMPING and sensitivity on SST.
4. Calcification above 1 cm in one of the dimensions by US or aray of the shoulder.
5. Completed conservative treatment: physiotherapy or analgesics.

Exclusion criteria

1. Diabetes, Nephrological diseases
2. RC tear according to US.
3. Prior operation in this shoulder
4. Steroids injection in the last three months.
5. A patient that is in the absorption phase of the tendinitis
6. Pregnancy
7. Coagulation System impairments

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind