Supraespinatus Tendinopathy
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
University Hospital of the Nuestra Señora de Candelaria
Fidia Farmaceutici s.p.a.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QuickDASH questionary | 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration | The QuickDASH is a validated patient-reported outcome measure used to evaluate changes in upper extremity symptoms and functional disability after treatment. |
| Constant-Murley questionary | 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration | 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 |
| Visual Analog Scale | 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary effects | -immediately after the first intervention -immediately after the second intervention -4 weeks after intervention -12 weeks after intervention | Adverse events related to the procedure or the study treatment will be recorded throughout the study. |
| Analgesic and nonsteroidal anti-inflammatory drug (NSAID) consumption will be recorded throughout the study. | 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. | 12 weeks after second infiltration | — |
Outcome results
None listed