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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Supraespinatus Tendinopathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Single-Arm Observational 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.
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.
Primary outcome measures
- QuickDASH questionary [Time frame: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration]
- Constant-Murley questionary [Time frame: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration]
- Visual Analog Scale [Time frame: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration]
Secondary outcome measures (3)
- Secondary effects [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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07699406 · CHUNSC_2026_10