E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Calcific tendinitis of the shoulder |
|
E.1.1.1 | Medical condition in easily understood language |
Calcific tendinitis of the shoulder |
Kalkschulter |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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 |
|
E.2.2 | Secondary objectives of the trial |
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)
Number of patients who need further treatment after study treatment was given and up to 2 year follow-up
To measure the change of the size of the calcification from baseline to 4 and 24 month follow-ups on x-rays |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change of the Oxford Shoulder Score from baseline to 4 month follow-up in the three study groups |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | 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
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
Change of the size of the calcification from baseline to 4 and 24 month follow-ups, measured on x-rays
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.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Two and 6 weeks, 4, 8, 12 and 24 month follow-ups
Safety data will be registered and evaluated continuously |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 6 |