rotator cuff tendinopathy MedDRA version: 9.1 Level: LLT Classification code 10013298 Term: Disorders of bursae and tendons in shoulder region, unspecified
Conditions
Interventions
Trade Name: DEPOMEDROL+LID.*1F 1ML+1SIR
Pharmaceutical Form: Solution for injection
INN or Proposed INN: METILPREDNISOLONE
CAS Number: 83-43-2
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
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 - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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;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. | — |
Countries
Italy
Outcome results
None listed