Treatment of chronic rotator cuff tendinopathy with local steroid injection or hypertermia. A Randomized, prospective, clinical study. - ND
- Conditions
- rotator cuff tendinopathyMedDRA version: 9.1Level: LLTClassification code 10013298Term: Disorders of bursae and tendons in shoulder region, unspecified
- Registration Number
- EUCTR2008-003952-31-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 - Worker?s 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method