Treatment of Calcific Tendinitis of the Rotator Cuff
Condition: Shoulder Pain; Tendonitis; Calcinosis; Shoulder Impingement Syndrome
MeSH terms: Shoulder Pain; Shoulder Impingement Syndrome; Tendinopathy; Calcinosis
Study type: Interventional

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.
    

Detailed description: 
      Barbotage is a sonographically guided percutaneous needle aspiration and lavage of the
      calcium deposit in calcific tendinitis of the shoulder. Persisting pain in cacific tendinitis
      is considered to be a consequence of increased tendon volume or changed tendon texture in the
      area of the calcification which leads to secondary impingement and inflammation.
      Consequently, removal of the deposit should be a causal treatment measure.

      Scientific evidence for the efficacy of the barbotage procedure in patients with persistent
      symptoms from calcific tendinitis is still limited. The cyclic often self-limiting course of
      the disease, and an anticipated placebo effect, questions about the method's efficacy can
      only be answered by high-quality randomized studies. In this trial the investigators want to
      randomize a cohort of patients to (1) Ultrasound guided needling, lavage and subacromial
      steroid injection, (2) Ultrasound guided subacromial steroid injection or (3) Ultrasound
      guided lidocain injection (sham). The investigators want to follow the patients over two
      years with repeated testing with a set of validated outcome measures together with radiologic
      re-examinations. The investigators want to find out whether the active treatments (1, 2) are
      more effective than the sham treatment and whether there are differences in outcome between
      the two active treatments. To increase the generalizability of the investigators' results,
      the investigators want to perform the study as a multi-centre study.
    

Intervention name(s): Barbotage; Corticosteroid injection; Lidocain injection (sham)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 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.; 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.; 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.
Other intervention name(s): 20 mg Triamcinolon/; 9 ml Lidocain 1%; 9 ml Lidocain 1%; 20 mg Triamcinolon/; 9 ml Lidocain 1%
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: shoulder pain; rotator cuff; calcific tendonitis; barbotage