Hyaluronic Acid in Shoulder Tendinopathy

ConditionShoulder Tendinitis

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-65

SponsorCentre Hospitalier Departemental Vendee

About this trial

Multicentric, randomised study to compare the effectiveness on activity pain at 3 months of corticosteroid injection associated with hyaluronic acid with corticosteroids injection alone in patients with tendinopathy of the supraspinatus with clinical reevaluation at one, three and six months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Active patient aged between 18 and 65;

Patient suffering from pain compatible with supraspinatus tendinopathy for at least 2 months;

Patient with simple tendinopathy or partial tendon rupture;

Patient with tendinopathy confirmed by ultrasound or MRI;

Disqualifiers

Patient suffering from a transfixing tendon rupture;

Patients suffering from post-traumatic tendon rupture;

Patients suffering from calcific tendinopathy (calcification > 5 mm);

Patients with associated glenohumeral osteoarthritis;

Trial design

Design model

Parallel

Treatments tested in this trial

Hyaluronic acid injection
Drug
An injection of 2 ml of Acid hyaluronic
Corticosteroid injection
Drug
An injection of 1 ml of corticosteroids
Placebo injection
Drug
An injection of 2 ml of placebo (physiological serum)

Treatment groups

132 Participants

are divided into 2 treatment groups

Group A: Combination of corticosteroid and hyaluronic acid injectionExperimental treatment 2 interventions

Group B: Corticosteroid injection alonePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Visual analog scale pain on activity ranging from 0 to 100 mm at month 3.

Visual analog scale pain on activity ranging from 0 to 100 mm at month 3. Pain is defined by the worst pain felt during active examination: anterior elevation, abduction, internal and external rotation, etc.

Time frame

Month 3

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Departemental Vendee

Lead sponsor

Source ClinicalTrials.gov

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