Hyaluronic Acid Versus Platelet-Rich Plasma for Chronic Tendinopathy and Enthesopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorOrtonika Orthopedic Medical Clinic in Lublin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Hyaluronic acid injection
DeviceAssigned to: Arm 1
Autologous Platelet-Rich Plasma Injection
DeviceAssigned to: Arm 2
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - Hyaluronic Acid (HA)Active comparator 1 intervention
Group B: Arm 2 - Platelet-Rich Plasma (PRP)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 6 months after the second injection2
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.
Time frame
Baseline and 6 months after the second injection3
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.
Time frame
Baseline and 6 months after the second injectionSecondary outcomes
1
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.
Time frame
Baseline and 1, 3, and 12 months after the second injection2
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.
Time frame
Baseline and 1, 3, and 12 months after the second injection3
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.
Time frame
Baseline and 1, 3, and 12 months after the second injection4
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.
Time frame
From the second injection through 12 months of follow-upSponsors and contacts
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Source ClinicalTrials.gov