E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
rotator cuff tendinopathy |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013298 |
E.1.2 | Term | Disorders of bursae and tendons in shoulder region, unspecified |
|
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 |
To assess differences in disability specific quality of life in two groups of patients affected by chronic rotator cuff tendinopathy and treated with local steroid injections or hypertermia |
|
E.2.2 | Secondary objectives of the trial |
To assess differences in working capacity between the two groups of patients - To assess differences in the global function of the affected shoulder between the two groups of patients - To assess differences in residual pain between the two groups of patients |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Positive clinical signs for subacromial impingement (Neer test and Hawkins test) - Subacromial bursitis and/or degenerative/inflammatory rotator cuff tendinopathy without tendon tears, assessed by MRI examination. |
|
E.4 | Principal exclusion criteria |
Partial-thickness or full-thickness tears of rotator cuff. - Anterior-superior tears of rotator cuff involving subscapularis tendon. - Labral pathology amenable of a surgical repair (i.e. gleno-humeral instability associated to rotator cuff tendinophathy, SLAP lesion). - Os acromiale. - Degenerative arthritis of glenohumeral joint - Symptomatic arthritis of acromioclavicular joint - Rotator cuff arthropathy - Previous surgery to the same shoulder - Workers compensation claims - Neurological diseases affecting the upper limb (axillary nerve injuries, syringomiely). - Systemic inflammatory diseases. - Pathologies for which cortcosteroid are contraindicated (i.e. diabetes mellitus, hypercortisolism, peptic ulcer). - Tumors or metastasis at the shoulder recently treated with radiotherapy. - Cardiopathies. - Acute infections or osseous tuberculosis. - Pregnancy. - Skin diseases. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the difference in the clinical outcome at a short-term follow-up between local steroid injections and hypertermia in the treatment of rotator cuff tendinopathy. |
|
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 | Yes |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
ipertermia a 434 MHz (Sigma Hypert. Easytech) |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
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 | 1 |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |