Achilles Tendinopathy, Enthesopathy, Golfer's Elbow, Medial Epicondylitis, Tendinopathy
Conditions
Keywords
PRP, hyaluronic acid, tendinopathy, enthesopathy, Achilles tendon, epicondylopathy, platelet-rich plasma, intratendinous injection
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.
Interventions
Assigned to: Arm 1
DEVICEAutologous Platelet-Rich Plasma Injection
Assigned to: Arm 2
Sponsors
Ortonika Orthopedic Medical Clinic in Lublin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm parallel randomized study with a 1:1 allocation ratio
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Pain Intensity Measured Using the 100-Millimeter Visual Analog Scale at 6 Months | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| 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 | 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 From the Second Injection to Return to the Pre-Injury Level of Physical Activity | From the second injection through 12 months of follow-up | 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. |
| Number of Participants With Adverse Events, Serious Adverse Events, or Adverse Device Effects | From the first injection through 12 months after the second injection | 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. |
Countries
Poland
Contacts
CONTACTTomasz Wnuk, MD, PhD
PRINCIPAL_INVESTIGATORTomasz Wnuk, MD, PhD
Ortonika Orthopedic Medical Clinic
Outcome results
None listed