Hyaluronic Acid Versus Platelet-Rich Plasma for Chronic Tendinopathy and Enthesopathy

NCT07714811 | Recruiting

• 1 other identifier: 1.0 13.04.2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Medial Epicondylitis; Tendinopathy; Enthesopathy; Achilles Tendinopathy; Golfer's Elbow

Keywords

PRP; hyaluronic acid; tendinopathy; enthesopathy; Achilles tendon; epicondylopathy; platelet-rich plasma; intratendinous injection

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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

  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

  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

  From the second injection through 12 months of follow-up

• Number of Participants With Adverse Events, Serious Adverse Events, or Adverse Device Effects

  From the first injection through 12 months after the second injection

Study Arms (2)

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.

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.

Device: Autologous Platelet-Rich Plasma Injection

Interventions

Hyaluronic acid injection DEVICE

Assigned to: Arm 1

Arm 1 - Hyaluronic Acid (HA)

Autologous Platelet-Rich Plasma Injection DEVICE

Assigned to: Arm 2

Arm 2 - Platelet-Rich Plasma (PRP)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ortonika Orthopedic Medical Clinic in Lublin: lead

Study Sites (1)

Ortonika Orthopedic Medical Clinic in Lublin

Lublin, Lublin Voivodeship, 20-841, Poland

RECRUITING

MeSH Terms

Conditions

Tendinopathy; Enthesopathy; Elbow Tendinopathy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Elbow Injuries; Arm Injuries

Study Officials

• Tomasz Wnuk, MD, PhD

  Ortonika Orthopedic Medical Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Wnuk, MD, PhD

CONTACT

+48 538 360 332; tomashorto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm parallel randomized study with a 1:1 allocation ratio

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 20, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)