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| Name | Class |
|---|---|
| Fidia Farmaceutici s.p.a. | INDUSTRY |
This study aims to evaluate whether ultrasound-guided injections of low-molecular-weight hyaluronic acid (HyalotendĀ®) 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.
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| Measure | Description | Time Frame |
|---|---|---|
| QuickDASH questionary | The QuickDASH is a validated patient-reported outcome measure used to evaluate changes in upper extremity symptoms and functional disability after treatment. | 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 | 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. | 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary effects | Adverse events related to the procedure or the study treatment will be recorded throughout the study. | -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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited from the outpatient clinics of the Department of Physical Medicine and Rehabilitation at Hospital Universitario Nuestra SeƱora de Candelaria. Eligible participants will be patients referred to the department because of shoulder pain and/or impaired shoulder function. The diagnosis of chronic supraspinatus tendinopathy will be established by a rehabilitation physician based on the patient's medical history, physical examination, and ultrasound assessment, while excluding the presence of tendon calcifications and partial- or full-thickness tendon tears.
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| 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 |