Study on the Efficacy and Safety of Ultrasound-Guided Peritendinous Injection of Low-Molecular-Weight Hyaluronic Acid (Hyalotend®; 500-730 kDa) for Chronic Non-Calcific Supraspinatus Tendinopathy.

N/ANot Yet RecruitingNCT07699406

University Hospital of the Nuestra Señora de Candelaria30 enrolled

Overview

This study aims to evaluate whether ultrasound-guided injections of low-molecular-weight hyaluronic acid (Hyalotend®) can safely reduce pain and improve shoulder function in people with chronic non-calcific supraspinatus tendinopathy. Participants will receive two injections as part of their treatment and will be followed over time to assess changes in pain, shoulder function, medication use, treatment satisfaction, and any side effects. The information collected may help improve the treatment of this condition in future patients.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Supraespinatus Tendinopathy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years. * Clinical and ultrasound-confirmed diagnosis of chronic (\>12 weeks) supraspinatus tendinopathy. * No structural tendon tear, confirmed by ultrasound. * No tendon calcification, confirmed by ultrasound. * Previous failure of conservative treatment, including physical therapy and/or analgesic or anti-inflammatory medication. * Written informed consent provided. Exclusion Criteria: * Partial- or full-thickness supraspinatus tendon tear identified by ultrasound. * Calcific supraspinatus tendinopathy identified by ultrasound. * Subacromial-subdeltoid bursitis identified by ultrasound * Previous treatment with extracorporeal focus shock wave therapy within the last 3 months. * Previous corticosteroid or platelet-rich plasma (PRP) injection within the last 3 months. * History of hypersensitivity or allergy to hyaluronic acid or any of its components. * Uncontrolled systemic disease. * Other chronic rheumatologic or autoimmune diseases. * Pregnancy or breastfeeding.

Primary Outcomes

QuickDASH questionary

The QuickDASH is a validated patient-reported outcome measure used to evaluate changes in upper extremity symptoms and functional disability after treatment.

Time frame: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration

Constant-Murley questionary

The Constant-Murley Score is a validated shoulder-specific outcome measure used to assess changes in pain, activities of daily living, range of motion, and shoulder strength following treatment

Time frame: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration

Visual Analog Scale

Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS). Scores range from 0 (no pain) to 10 (worst imaginable pain), with lower scores indicating less pain.

Time frame: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration

Secondary Outcomes

Secondary effects

Adverse events related to the procedure or the study treatment will be recorded throughout the study.

Time frame: -immediately after the first intervention -immediately after the second intervention -4 weeks after intervention -12 weeks after intervention

Analgesic and nonsteroidal anti-inflammatory drug (NSAID) consumption will be recorded throughout the study.

Time frame: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration

Patient global satisfaction with the received treatment will be assessed.

Time frame: 12 weeks after second infiltration