TendinopathyNCT07714811
Hyaluronic Acid Versus Platelet-Rich Plasma for Chronic Tendinopathy and Enthesopathy
A study testing Hyaluronic acid injection and Autologous Platelet-Rich Plasma Injection in people with Tendinopathy and Enthesopathy, run by Ortonika Orthopedic Medical Clinic in Lublin at 1 site in Poland.
Trial summary
Chronic tendinopathies and enthesopathies are common musculoskeletal conditions in orthopedics and sports medicine, frequently leading to pain, impaired function, and significantly reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tendinopathy, Enthesopathy, Achilles Tendinopathy
- What is being tested?
- Hyaluronic acid injection and Autologous Platelet-Rich Plasma Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jun 2026to Jun 2028
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic tendinopathy or enthesopathy of the Achilles tendon or tendon insertion in the elbow region (medial epicondylopathy, so-called golfer's elbow)
- Symptom duration exceeding 3 months
- Pain intensity of at least 40 millimeters (mm) on a 100-mm Visual Analog Scale (VAS)
- Age 18-65 years
- Signed written informed consent
Who cannot join
- Previous surgical treatment of the studied tendon or tendon insertion
- Prior injection of corticosteroids, platelet-rich plasma (PRP), or hyaluronic acid into the area being studied within 3 months before enrollment
- Active systemic or local infection at the planned injection site
- Systemic inflammatory or autoimmune disease involving the joints, including rheumatoid arthritis, spondyloarthritis, or systemic lupus erythematosus
- Pregnancy or breastfeeding
- Body mass index (BMI) of 40 kilograms per square meter (kg/m²) or greater
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Ortonika Orthopedic Medical Clinic in Lublin
Lublin, Lublin Voivodeship, 20-841
Tomasz Wnuk, MD, PhD, +48 538 360 332, tomashorto@gmail.com
Tomasz Wnuk, MD, PhD
About this study
Official title: Comparative Analysis of the Efficacy of Hyaluronic Acid and Platelet-Rich Plasma Injections in the Treatment of Chronic Tendinopathies and Enthesopathies: A Prospective, Randomized Comparative Study
Chronic tendinopathies and enthesopathies are common musculoskeletal conditions in orthopedics and sports medicine, frequently leading to pain, impaired function, and significantly reduced quality of life. Their pathogenesis involves tissue degeneration and ineffective repair response, often without an active inflammatory process.
Standard conservative management based on physiotherapy and activity modification is often prolonged and not always satisfactory. Minimally invasive injectable interventions supporting tendon and enthesis regeneration represent a promising alternative due to their favorable safety profile and outpatient feasibility.
Read more
Hyaluronic acid (HA) is a glycosaminoglycan naturally present in connective tissues. In the context of tendinopathy, it is thought to modulate inflammatory processes, provide mechanical protection by reducing friction and adhesion within the tendon sheath, and support the proper organization of collagen fibers in the tendon matrix.
Platelet-rich plasma (PRP) is an autologous concentrate of platelets providing high local concentrations of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor beta (TGF-β), and vascular endothelial growth factor (VEGF), which initiate and support repair processes, cellular proliferation, and angiogenesis.
This prospective, randomized, open-label, two-arm study aims to compare the clinical efficacy of hyaluronic acid (HA) and platelet-rich plasma (PRP) injections in 80 participants with chronic Achilles tendinopathy or medial epicondylopathy of the elbow. Participants will be randomly assigned in a 1:1 ratio to receive either two HA injections or two PRP injections administered two weeks apart under ultrasonographic guidance. Follow-up will continue for 12 months after the second injection. The primary outcomes are the changes from baseline to 6 months in pain intensity measured using a 100-millimeter (mm) Visual Analog Scale (VAS), upper-limb function measured using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in participants with medial epicondylopathy, and Achilles tendon symptoms and function measured using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire in participants with Achilles tendinopathy. The results will provide evidence to support the selection of injectable treatment for chronic tendinopathies and enthesopathies.
- Being tested
- Hyaluronic acid injection, Autologous Platelet-Rich Plasma Injection
- Keywords
- PRP, hyaluronic acid, tendinopathy, enthesopathy, Achilles tendon, epicondylopathy, platelet-rich plasma, intratendinous injection
- Medical subject headings
- Tendinopathy, Enthesopathy, Elbow Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid injectionDevice
Assigned to: Arm 1
Autologous Platelet-Rich Plasma InjectionDevice
Assigned to: Arm 2
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Hyaluronic Acid (HA) | Active comparator | Two peritendinous or intratendinous injections of hyaluronic acid (HA), containing 32 milligrams (mg) of sodium hyaluronate in 2 milliliters (mL) per injection, administered two weeks apart under ultrasonographic guidance. Receives: Device: Hyaluronic acid injection |
| Arm 2 - Platelet-Rich Plasma (PRP) | Experimental | Two peritendinous or intratendinous injections of autologous platelet-rich plasma (PRP), administered two weeks apart under ultrasonographic guidance. Receives: Device: Autologous Platelet-Rich Plasma Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months
Pain intensity will be measured using a 100-millimeter (mm) Visual Analog Scale (VAS), ranging from 0 mm, indicating no pain, to 100 mm, indicating the worst imaginable pain. The outcome will be the mean change in VAS score from baseline to 6 months after the second injection. A decrease in score indicates improvement.
Measured: Baseline and 6 months after the second injection
Mean Change From Baseline in the Quick Disabilities of the Arm, Shoulder and Hand Score at 6 Months
Upper-limb symptoms and function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in participants with medial epicondylopathy. The total score ranges from 0 to 100 points, with higher scores indicating greater disability. The outcome will be the mean change from baseline to 6 months after the second injection. A decrease in score indicates improvement.
Measured: Baseline and 6 months after the second injection
Mean Change From Baseline in the Victorian Institute of Sport Assessment-Achilles Score at 6 Months
Symptoms and function associated with Achilles tendinopathy will be assessed using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire in participants with Achilles tendinopathy. The total score ranges from 0 to 100 points, with higher scores indicating better function and fewer symptoms. The outcome will be the mean change from baseline to 6 months after the second injection. An increase in score indicates improvement.
Measured: Baseline and 6 months after the second injection
Secondary outcomes (5)
Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 1, 3, and 12 Months
Pain intensity will be measured using a 100-millimeter (mm) Visual Analog Scale (VAS), ranging from 0 mm, indicating no pain, to 100 mm, indicating the worst imaginable pain. Mean changes from baseline will be assessed separately at 1, 3, and 12 months after the second injection. A decrease in score indicates improvement.
Measured: Baseline and 1, 3, and 12 months after the second injection
Mean Change From Baseline in the Quick Disabilities of the Arm, Shoulder and Hand Score at 1, 3, and 12 Months
Upper-limb symptoms and function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in participants with medial epicondylopathy. The total score ranges from 0 to 100 points, with higher scores indicating greater disability. Mean changes from baseline will be assessed separately at 1, 3, and 12 months after the second injection. A decrease in score indicates improvement.
Measured: Baseline and 1, 3, and 12 months after the second injection
Mean Change From Baseline in the Victorian Institute of Sport Assessment-Achilles Score at 1, 3, and 12 Months
Symptoms and function associated with Achilles tendinopathy will be assessed using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire in participants with Achilles tendinopathy. The total score ranges from 0 to 100 points, with higher scores indicating better function and fewer symptoms. Mean changes from baseline will be assessed separately at 1, 3, and 12 months after the second injection. An increase in score indicates improvement.
Measured: Baseline and 1, 3, and 12 months after the second injection
Time From the Second Injection to Return to the Pre-Injury Level of Physical Activity
The number of days from the second injection to the first documented return to the participant's pre-injury level of physical activity without activity restrictions will be recorded. Participants who do not return to their pre-injury activity level during follow-up will be considered not to have experienced the event by the end of the 12-month follow-up period.
Measured: From the second injection through 12 months of follow-up
Number of Participants With Adverse Events, Serious Adverse Events, or Adverse Device Effects
The number and percentage of participants experiencing one or more adverse events (AEs), serious adverse events (SAEs), or adverse device effects (ADEs) will be reported. Events will be assessed according to their type, severity, seriousness, and relationship to the administered intervention.
Measured: From the first injection through 12 months after the second injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start10 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel randomized study with a 1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ortonika Orthopedic Medical Clinic in Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Wnuk, MD, PhD, Ortonika Orthopedic Medical Clinic in Lublin
- Investigators
- Tomasz Wnuk, MD, PhD, Principal investigator, Ortonika Orthopedic Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714811
- Sponsor's protocol ID
- 1.0 13.04.2026
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of the Efficacy of Hyaluronic Acid and Platelet-Rich Plasma Injections in the Treatment of Chronic Tendinopathies and Enthesopathies: A Prospective, Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07714811
- Acronym / sponsor ID
- 1.0 13.04.2026
- Keywords
- PRP, hyaluronic acid, tendinopathy, enthesopathy, Achilles tendon, epicondylopathy, platelet-rich plasma, intratendinous injection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ortonika Orthopedic Medical Clinic in LublinUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 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.
Chronic tendinopathies and enthesopathies are common musculoskeletal conditions in orthopedics and sports medicine, frequently leading to pain, impaired function, and significantly reduced quality of life. Their pathogenesis involves tissue degeneration and ineffective repair response, often without an active inflammatory process.
Standard conservative management based on physiotherapy and activity modification is often prolonged and not always satisfactory. Minimally invasive injectable interventions supporting tendon and enthesis regeneration represent a promising alternative due to their favorable safety profile and outpatient feasibility.
Hyaluronic acid (HA) is a glycosaminoglycan naturally present in connective tissues. In the context of tendinopathy, it is thought to modulate inflammatory processes, provide mechanical protection by reducing friction and adhesion within the tendon sheath, and support the proper organization of collagen fibers in the tendon matrix.
Platelet-rich plasma (PRP) is an autologous concentrate of platelets providing high local concentrations of growth factors, including platelet-derived growth factor (PDGF), transforming growth factor beta (TGF-β), and vascular endothelial growth factor (VEGF), which initiate and support repair processes, cellular proliferation, and angiogenesis.
This prospective, randomized, open-label, two-arm study aims to compare the clinical efficacy of hyaluronic acid (HA) and platelet-rich plasma (PRP) injections in 80 participants with chronic Achilles tendinopathy or medial epicondylopathy of the elbow. Participants will be randomly assigned in a 1:1 ratio to receive either two HA injections or two PRP injections administered two weeks apart under ultrasonographic guidance. Follow-up will continue for 12 months after the second injection. The primary outcomes are the changes from baseline to 6 months in pain intensity measured using a 100-millimeter (mm) Visual Analog Scale (VAS), upper-limb function measured using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in participants with medial epicondylopathy, and Achilles tendon symptoms and function measured using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire in participants with Achilles tendinopathy. The results will provide evidence to support the selection of injectable treatment for chronic tendinopathies and enthesopathies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm parallel randomized study with a 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Hyaluronic Acid (HA) | Active comparator | Device: Hyaluronic acid injectionTwo peritendinous or intratendinous injections of hyaluronic acid (HA), containing 32 milligrams (mg) of sodium hyaluronate in 2 milliliters (mL) per injection, administered two weeks apart under ultrasonographic guidance. |
| Arm 2 - Platelet-Rich Plasma (PRP) | Experimental | Device: Autologous Platelet-Rich Plasma InjectionTwo peritendinous or intratendinous injections of autologous platelet-rich plasma (PRP), administered two weeks apart under ultrasonographic guidance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic tendinopathy or enthesopathy of the Achilles tendon or tendon insertion in the elbow region (medial epicondylopathy, so-called golfer's elbow)
- Symptom duration exceeding 3 months
- Pain intensity of at least 40 millimeters (mm) on a 100-mm Visual Analog Scale (VAS)
- Age 18-65 years
- Signed written informed consent
Key exclusion criteria (6 listed)
- Previous surgical treatment of the studied tendon or tendon insertion
- Prior injection of corticosteroids, platelet-rich plasma (PRP), or hyaluronic acid into the area being studied within 3 months before enrollment
- Active systemic or local infection at the planned injection site
- Systemic inflammatory or autoimmune disease involving the joints, including rheumatoid arthritis, spondyloarthritis, or systemic lupus erythematosus
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic acid injectionAssigned to: Arm 1 | Device | Arm 1 - Hyaluronic Acid (HA) |
| Autologous Platelet-Rich Plasma InjectionAssigned to: Arm 2 | Device | Arm 2 - Platelet-Rich Plasma (PRP) |
Primary outcome
Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months
Time frame: Baseline and 6 months after the second injection
Pain intensity will be measured using a 100-millimeter (mm) Visual Analog Scale (VAS), ranging from 0 mm, indicating no pain, to 100 mm, indicating the worst imaginable pain. The outcome will be the mean change in VAS score from baseline to 6 months after the second injection. A decrease in score indicates improvement.
Mean Change From Baseline in the Quick Disabilities of the Arm, Shoulder and Hand Score at 6 Months
Time frame: Baseline and 6 months after the second injection
Upper-limb symptoms and function will be assessed using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire in participants with medial epicondylopathy. The total score ranges from 0 to 100 points, with higher scores indicating greater disability. The outcome will be the mean change from baseline to 6 months after the second injection. A decrease in score indicates improvement.
Mean Change From Baseline in the Victorian Institute of Sport Assessment-Achilles Score at 6 Months
Time frame: Baseline and 6 months after the second injection
Symptoms and function associated with Achilles tendinopathy will be assessed using the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire in participants with Achilles tendinopathy. The total score ranges from 0 to 100 points, with higher scores indicating better function and fewer symptoms. The outcome will be the mean change from baseline to 6 months after the second injection. An increase in score indicates improvement.
5 secondary outcomes
Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 1, 3, and 12 Months
Time frame: Baseline and 1, 3, and 12 months after the second injection
Mean Change From Baseline in the Quick Disabilities of the Arm, Shoulder and Hand Score at 1, 3, and 12 Months
Time frame: Baseline and 1, 3, and 12 months after the second injection
Mean Change From Baseline in the Victorian Institute of Sport Assessment-Achilles Score at 1, 3, and 12 Months
Time frame: Baseline and 1, 3, and 12 months after the second injection
Time From the Second Injection to Return to the Pre-Injury Level of Physical Activity
Time frame: From the second injection through 12 months of follow-up
Number of Participants With Adverse Events, Serious Adverse Events, or Adverse Device Effects
Time frame: From the first injection through 12 months after the second injection
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 20 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Tomasz Wnuk, MD, PhD principal investigator
Ortonika Orthopedic Medical Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid injection and Autologous Platelet-Rich Plasma Injection in people with Tendinopathy and Enthesopathy, run by Ortonika Orthopedic Medical Clinic in Lublin at 1 site in Poland.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Tomasz Wnuk, MD, PhD (+48 538 360 332, tomashorto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months (time frame: Baseline and 6 months after the second injection). 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 20 Jul 2026.