Please select the eligibility criteria that correspond to the clinical trial below.
Title: Treatment of Calcific Tendinitis of the Rotator Cuff - a Multi-centre, Randomized and Sham Controlled Trial (KALK Study)
Brief 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.


Options:
A: Inclusion Criteria:

* Subacromial shoulder pain lasting for at least three months and age between 18 and 70 years.
* Dysfunction or pain on abduction
* Had a normal passive glenohumeral range of movement
* Pain during two of three isometric tests (abduction, external- or internal rotation at 0º or 30º)
* Positive Hawkins-Kennedys test.

Exclusion Criteria:

* Shoulder pain bilateral (both shoulders required treatment)
* Earlier operated in affected shoulder
* Had multidirectional instability
* Had the cervical syndrome
* Rheumatoid arthritis
* Clinical and radiological findings indicating glenohumeral - or acromioclavicular joint pathology
* Not able to understand spoken or written Norwegian
* Considerable emotional distress
* Needed anticoagulant medicine
* Being pregnant
* Had had Shock Wave Therapy or Supervised Exercises before.
B: Inclusion Criteria:

* diagnosis of CRCP as evident by symptoms and signs including pain on active abduction or external rotation and positive impingement test;
* symptoms of pain in shoulder for \> 3 months;
* average movement pain \> 3 on a 10 cm visual analogue scale;
* aged ≥ 18 years;
* able to understand written and spoken English.

Exclusion Criteria:

* severe pain at rest, defined as \> 7 on a visual analogue scale;
* global restriction of shoulder movements;
* systemic inflammatory joint disease;
* x-ray evidence of shoulder osteoarthritis or fracture;
* calcification about the shoulder joint;
* reason to suspect a complete rotator cuff rupture (eg. weakness of arm elevation, a positive "drop arm sign", a high riding humerus visible on x-ray or a complete tear on ultrasound);
* previous shoulder surgery on affected arm;
* physiotherapy, corticosteroid injection or hydrodilatation for shoulder in past 3 months;
* commenced non-steroidal antiinflammatory medication (NSAIDs) or conservative intervention in past 2 weeks.
C: Inclusion Criteria:

* Sub-acromial pain of at least 3 month (tendinopathy and partial tear only).
* Diagnosed by a Consultant of tendinopathic pain or partial thickness rotator cuff tear
* Has had an MRI or Ultrasound Scan to rule out alternative pathology
* Eligible for surgery.
* Completed a conservative management programme previously including:

  * physiotherapy that includes a remedial exercise regimen and
  * at least x1 cortisone injection but not more than 3 injections.

Exclusion Criteria:

* Full thickness tear of the rotator cuff tendons evident on MRI or Ultrasound imaging
* Undergone previous surgery on affected shoulder
* Have RA or other inflammatory disorder
* Symptomatic cervical spine pathology
* Previous septic arthritis
* History of radiotherapy on same side as affected shoulder
* Patients who have a strong preference for one treatment over another to an extent that they would not participate if allocated to their non- preferred group.
D: Inclusion Criteria:

1. 30 years or older
2. 3 months or more of shoulder pain
3. Moderate to strong pain localized on the top and/or lateral side of the shoulder, exaggerated by activities above shoulder level
4. Painful arc
5. Positive Hawkin's test and/or Neer's sign for impingement
6. Finding of one or more calcifications ≥5 mm in size on a standard anteriorposterior radiograph, localized proximally to the greater tubercle, together with a sonographic finding of one or more calcifications ≥5 mm in size on the short or long axis view, localized in the supraspinatus or infraspinatus tendon
7. Morphological radiographic appearance of Molé type A, B or C12 (appendix 2) A: Dense, homogeneous with well-defined limits B: Dense, fragmented with well-defined limits C: Heterogeneous with poorly defined limits and sometimes with a punctuate appearance
8. Ability to understand written and spoken Norwegian (Swedish/English)
9. Existing signed informed consent and expected cooperation of the patients for the treatment and the follow-up

Exclusion criteria:

1. Clinical and radiological signs of a recent spontaneous release of the deposit such as a sudden change in size or density of the deposit on ultrasound together with an acute onset of extreme shoulder pain
2. Clinical signs of shoulder instability, glenohumeral arthritis, AC pathology, inflammatory arthropathy, fibromyalgia, frozen shoulder or cervical radiculopathy
3. Sonographic signs for a rotator cuff tear (full thickness or partial thickness) and of a tear or a dislocation of the long head of the biceps tendon
4. A history of surgical treatment of the relevant shoulder
5. A subacromial injection with a corticosteroid during the last 3 months before inclusion
6. Medical contraindications for any of the invasive procedures
7. One of the following contraindications for the use of Lidocaine 10 mg/ml: Patients with serious hypovolaemia, known cardiac conduction disturbances, epilepsy or porphyrias, patients with known serious dysfunction of the liver or the kidneys.
8. One of the following contraindications for the use of Triamcinolone 20 mg/ml: Patients with systemic infections unless specific anti-infective therapy is employed, patients with a local infection in the area of application, patients recently vaccinated with live vaccines, patients with known diabetes mellitus, renal or cardiac insufficiency, ulcerating colitis, gastric ulcer, psychosis, idiopathic thrombocytopenic purpura, or ocular herpes simplex.
9. Concomitant medication with one of the following medicinal products: Anti-arrythmics such as mexiletine or class III antiarrythmics (e.g. amiodarone), muscle relaxants (e.g. suxamethonium) or antipsychotics (e.g. pimozide, sertindole, olanzapine, quetiapine, zotepine, tropisetrone, dolasetron), antibiotics such as quinopristin/dalfopristin.
10. Any history of prior allergic/hypersensitivity reactions related to the study medication
11. Knowledge of an ongoing pregnancy (Fertile women not using contraception and who are uncertain whether they are pregnant or not will have to perform a pregnancy test)
12. Nursing women

Answer: D