Clinical Benefits and Safety of Tropho Tend in the Management of Painful Rotator Cuff Tendinopathy

The Primary Endpoint measure is the variation of VAS Visual Analogue Scale of pain and of function (VAS; 0-10 cm, where 0= no pain or no function impairment and 10= worse pain or function impairment) in the "Tropho Tend therapy group" compared with the "control group". A 40% reduction in mean VAS scores between the "Tropho Tend therapy group" and the "control group" is considered as reflecting meaningful clinical improvement for the patient.

SPADI Index is designed to measure current shoulder pain and function of daily tasks in an outpatient setting.

The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.

The pain dimension consists of five questions regarding the severity of an individual's pain.

Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.

The Primary Endpoint measure is also the change from baseline of the single assessment numeric evaluation (SANE), which was designed as a simple one-question: "how would you rate your shoulder today as a percentage of normal (0% to 100%, with 100% being normal)?"

Patient's satisfaction with the treatment using a 5-points Likert scale (1=very dissatisfied, 2=dissatisfied, 4=neutral, 4=satisfied, 5=highly satisfied). A final score of 2 points or more on the Likert scale at the last clinical investigation visit will be considered clinically significant.

A qualitative description of the ultrasound appearance of the tendon will be required to compare the final follow-up visit to that of an ultrasound performed at the baseline visit in both groups

The EQ-5D-3L descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems. The respondent is asked to indicate his / her health state by checking the box against the most appropriate statement in each of the five dimensions. The EQ VAS records the respondent's self-rated health on a vertical VAS where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents. The scale used for the answers is the EQ visual analogue scale (EQ VAS). It consists of a vertical 100 point visual analogue scale with two extreme endpoints (0= worst health status; 100=best health status).

Adverse events (AE) will be monitored throughout the trial. At each scheduled visit, a safety assessment has to be conducted by the investigator. The intensity (mild/moderate/severe) will be assessed according to the investigator's judgement. If a patient drops out of the clinical investigation, the possible reasons for drop-out, including no improvement in the tendinopathy or occurrence of unacceptable signs/symptoms, need to be documented.