Shoulder Pain Clinical Trial
Official title:
Treatment of Calcific Tendinitis of the Rotator Cuff - a Multi-centre, Randomized and Sham Controlled Trial (KALK Study)
NCT number | NCT02419040 |
Other study ID # | KALK-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | April 2022 |
Verified date | October 2023 |
Source | Martina Hansen's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 220 |
Est. completion date | April 2022 |
Est. primary completion date | April 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Norway | Martina Hansen's Hospital | Sandvika |
Lead Sponsor | Collaborator |
---|---|
Martina Hansen's Hospital | Haraldsplass Deaconess Hospital, Helse Fonna, Oslo University Hospital, Sykehuset i Vestfold HF, University Hospital, Linkoeping |
Norway,
Moosmayer S, Ekeberg OM, Hallgren HB, Heier I, Kvalheim S, Blomquist J, Pripp AH, Juel NG, Kjellevold SH, Brox JI; KALK study group. KALK study: ultrasound guided needling and lavage (barbotage) with steroid injection versus sham barbotage with and without steroid injection - protocol for a randomized, double-blinded, controlled, multicenter study. BMC Musculoskelet Disord. 2017 Apr 4;18(1):138. doi: 10.1186/s12891-017-1501-9. — View Citation
Moosmayer S, Ekeberg OM, Hallgren HB, Heier I, Kvalheim S, Juel NG, Blomquist J, Pripp AH, Brox JI. Ultrasound guided lavage with corticosteroid injection versus sham lavage with and without corticosteroid injection for calcific tendinopathy of shoulder: — View Citation
Robinson DM, McInnis KC, Rhim HC, Tsitsilianos N. Lavage treatments for calcific rotator cuff tendinopathy. BMJ. 2023 Oct 11;383:p2248. doi: 10.1136/bmj.p2248. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Size of calcific deposits | Measured in millimeter AP radiographs | 4 and 24 months | |
Other | Volume of removed calcific deposit | Volume of removed calcific deposit in milliliter | Baseline | |
Primary | Oxford Shoulder Score | Shoulder pain and disability | 4 months | |
Secondary | Oxford Shoulder Score | Shoulder pain and disability | after 2 and 6 weeks, and 8, 12 and 24 months | |
Secondary | QuickDASH Disability of shoulder, arm and hand | Shoulder pain and disability | after 2 and 6 weeks, and 4, 8, 12 and 24 months | |
Secondary | EQ 5D-5L | Health related quality of life | 4, 8, 12 and 24 months | |
Secondary | Cross-over of patients | number of patients crossing over to other group or other treatment | 4, 8, 12 and 24 months | |
Secondary | Adverse-events | Patient reported adverse events | 2 and 6 weeks, and 4 months |
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