COMPARISON BETWEEN INTRA-ARTICULAR INJECTION OF CORTICOSTEROIDS AND INTRA-ARTICULAR INJECTION OF HYALURONIC ACID IN THE TREATMENT OF ROTATOR CUFF TENDINOPATHY. A PROSPECTIVE CLINICAL TRIAL.

• Conditions: ROTATOR CUFF TENDINOPATHY; MedDRA version: 14.1Level: PTClassification code 10039227Term: Rotator cuff syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2011-003207-37-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-23
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

-Positive subacromial impingment tests (Neer’s test and Hawkin’s test)
-Degenerative changes of rotator cuff tendons with no loss of continuity and/or subacromial bursitis, investigated with a MRI study
-Signing an agreement disclosure form.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 61
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 31

Exclusion Criteria

-Full-thickness tear of rotator cuff
-Antero-superior cuff tear, involving the subscapularis tendon
-Labral pathology amenable to surgical repair (i.e. gleno-humeral instability associated to rotator cuff tendinopathy, SLAP lesions
-Os acromiale
-Degenerative arthritis of the glenohumeral joint,
-Symptomatic arthritis of acromioclavicular joint,
-Previous surgery on the same shoulder
-Workers’ Compensation claims
-Neurological diseases involving the shoulder girdle (i.e. axillary nerve tears, syringomyelia)
-Systemic inflammatory diseases
-Pathologies for which cortcosteroid are contraindicated (i.e. diabetes mellitus, hypercortisolism, peptic ulcer).
-Tumor or metastatic disease
-Heart diseases
-Active infection or bone TB
-Pregnancy.
-Acute skin disease
-Predictable poor compliance to treatment
-Difficulty in completing questionnaires.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to evaluate the differences between intra-articular injection with corticosteroids and hyaluronic acid in the treatment of rotator cuff tendinopathy at a short-term follow-up;Secondary Objective: Secondary outcomes of the study include:<br>-Evaluation of differences of the global health status of the affected shoulder with a specific scoring system (Constant-Murley score). <br>-Evaluation of differences in pain with a Visual Analogic Scale (VAS score).;Primary end point(s): Primary outcome will be measured with the validated Italian version of DASH questionnaire (Disability of Arm, Shoulder and Hand), in its shortened version (Quick-DASH).;Timepoint(s) of evaluation of this end point: 1-3-6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary outcome is the Constant Score, introduced by the ESSSE (European Society for Surgery of the Shoulder and the Elbow) to evaluate the function of the shoulder. The Constant score consists of four variables: pian, ADL, range of motion and strenght. Total score ranges from 0 to 100 points and it can be pondered for age and sex, based on specific conversion tables.<br>Other secondary outcome is the evaluation of pain using a Visual Analog Scale (VAS) based on a metric scale ranging from 0 (no pain) to 100 points (extreme pain). Patient assigns the score independently.;Timepoint(s) of evaluation of this end point: 1-3-6 months