Treatment of calcific tendinitis of the shoulder

Phase 1

• Conditions: Calcific tendinitis of the shoulder; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-002343-34-NO
• Lead Sponsor: Martina Hansens Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-06
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

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 C
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
9.Existing signed informed consent and expected cooperation of the patients for the treatment and the follow-up

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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.Any 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Four months after the intervention, measured by the Oxford shoulder score (PROM): To assess the supplementary therapeutic effect of removal of the calcific deposit compared to antiinflammatory treatement alone<br><br>Four months after the intervention, measured by the Oxford shoulder score: To compare the effekt of (1) removal of the calcific deposit and of (2) antiinflammatory treatment alone to placebo treatment ;Secondary Objective: The same objectives as given under Main effects but after 8, 12 and 24 months and on all other study scores (all study scores are PROMs)<br><br>Number of patients who need further treatment after study treatment was given and up to 2 year follow-up<br><br>To measure the change of the size of the calcification from baseline to 4 and 24 month follow-ups on x-rays;Primary end point(s): Change of the Oxford Shoulder Score from baseline to 4 month follow-up in the three study groups;Timepoint(s) of evaluation of this end point: Four month follow-up

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change of the Oxford shoulder score from baseline to 2 and 6 week, 8, 12 and 24 month follow-ups in the three study groups<br><br>Change of the other study scores (Quick-Dash, EQ-5D-5L, pain-VAS) from baseline to 2 and 6 week, 4, 8, 12 and 24 month follow-ups in the three study groups<br><br>Change of the size of the calcification from baseline to 4 and 24 month follow-ups, measured on x-rays <br><br>Safety data collected during the study (occurrence and nature of AEs, SAEs and SUSARs) will be presented and discussed in the safety evaluation part of the Clinical Study Report and will be compared between groups. <br>;Timepoint(s) of evaluation of this end point: Two and 6 weeks, 4, 8, 12 and 24 month follow-ups<br><br>Safety data will be registered and evaluated continuously