Treatment of Calcific Tendinitis of the Rotator Cuff

• Register: ClinicalTrials.gov
• Last refreshed on: 6 November 2023
• Main ID: NCT02419040
• Date of registration: 10/04/2015
• Prospective Registration: No
• Primary sponsor: Martina Hansen's Hospital
• Public title: Treatment of Calcific Tendinitis of the Rotator Cuff
• Scientific title: Treatment of Calcific Tendinitis of the Rotator Cuff - a Multi-centre, Randomized and Sham Controlled Trial (KALK Study)
• Date of first enrolment: April 2015
• Target sample size: 220
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02419040
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Stefan Moosmayer, MD, PhD
• Affiliation: MHH Martine Hansens Hospital

Key inclusion & exclusion criteria

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



Age minimum: 30 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Calcinosis

Shoulder Pain

Tendonitis

Shoulder Impingement Syndrome

Intervention(s)

Procedure: Corticosteroid injection

Procedure: Lidocain injection (sham)

Procedure: Barbotage

Primary Outcome(s)

Oxford Shoulder Score [Time Frame: 4 months]

Secondary Outcome(s)

Adverse-events [Time Frame: 2 and 6 weeks, and 4 months]

Oxford Shoulder Score [Time Frame: after 2 and 6 weeks, and 8, 12 and 24 months]

Cross-over of patients [Time Frame: 4, 8, 12 and 24 months]

EQ 5D-5L [Time Frame: 4, 8, 12 and 24 months]

QuickDASH Disability of shoulder, arm and hand [Time Frame: after 2 and 6 weeks, and 4, 8, 12 and 24 months]

Secondary ID(s)

KALK-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sykehuset i Vestfold HF

Oslo University Hospital

Haraldsplass Deaconess Hospital

Helse Fonna

University Hospital, Linkoeping