Treatment of Calcific Tendinitis of the Rotator Cuff

Summary

The purpose of this study is to determine whether the combination of removal of the calcification in calcific tendinitis of the shoulder (supraspinatus and/or infraspinatus tendon) by aspiration with a needle and syringe (barbotage) and a corticosteroid injection is more effective than corticosteroid or sham injection alone.

Conditions

• Shoulder Pain
• Tendonitis
• Calcinosis
• Shoulder Impingement Syndrome

Interventions

PROCEDURE

Barbotage

A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.

PROCEDURE

Corticosteroid injection

The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.

PROCEDURE

Lidocain injection (sham)

The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 10 ml of 1% Lidocain hydrochlorid will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.

Sponsors & Collaborators

• Helse Fonna

  collaborator OTHER

• Oslo University Hospital

  collaborator OTHER

• Sykehuset i Vestfold HF

  collaborator OTHER

• Haraldsplass Deaconess Hospital

  collaborator OTHER

• University Hospital, Linkoeping

  collaborator OTHER

• Martina Hansen's Hospital

  lead OTHER

Principal Investigators

• Stefan Moosmayer, MD, PhD · MHH Martine Hansens Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2022-04-30

Completion

2022-04-30

Countries

• Norway

Study Locations