Supraespinatus TendinopathyNCT07699406
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.
An observational study of Supraespinatus Tendinopathy, run by University Hospital of the Nuestra Señora de Candelaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supraespinatus Tendinopathy
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Mar 2027
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients will be recruited from the outpatient clinics of the Department of Physical Medicine and Rehabilitation at Hospital Universitario Nuestra Señora 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Uncontrolled systemic disease.
- Other chronic rheumatologic or autoimmune diseases.
- Pregnancy or breastfeeding.
About this study
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.
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.
- Conditions
- Supraespinatus Tendinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
QuickDASH questionary
The QuickDASH is a validated patient-reported outcome measure used to evaluate changes in upper extremity symptoms and functional disability after treatment.
Measured: 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
Measured: 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.
Measured: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration
Secondary outcomes (3)
Secondary effects
Adverse events related to the procedure or the study treatment will be recorded throughout the study.
Measured: -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.
Measured: 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.
Measured: 12 weeks after second infiltration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraespinatus TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- University Hospital of the Nuestra Señora de Candelaria
- Sponsor type
- University, hospital or other
- Collaborators
- Fidia Farmaceutici s.p.a.
- Responsible party
- Principal investigator, Marcos Rufino Navarro, University Hospital of the Nuestra Señora de Candelaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699406
- Sponsor's protocol ID
- CHUNSC_2026_10
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07699406
- Acronym / sponsor ID
- CHUNSC_2026_10
- Conditions
- Supraespinatus Tendinopathy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital of the Nuestra Señora de CandelariaUniversity, hospital or other
- Collaborators
- Fidia Farmaceutici s.p.a.
- Study start
- Jul 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from the outpatient clinics of the Department of Physical Medicine and Rehabilitation at Hospital Universitario Nuestra Señora 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QuickDASH questionary
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Supraespinatus Tendinopathy, run by University Hospital of the Nuestra Señora de Candelaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QuickDASH questionary (time frame: 1. Before infiltrations 2. 4 weeks after second infiltration 3. 12 weeks after second infiltration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.