- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410663
Hyaluronic Acid and Amino Acid Combination Versus Exercise for Chronic Lateral Epicondylitis
February 7, 2026 updated by: Serkan Polat, Sivas State Hospital
A New Era in the Treatment of Chronic Lateral Epicondylitis: Comparison of Targeted Biological Support Using a Hyaluronic Acid and Amino Acid Combination Versus Exercise Therapy: A Retrospective, Controlled Clinical Study
This retrospective, controlled clinical study aims to evaluate the effectiveness of a targeted biological support injection containing a hyaluronic acid and amino acid combination in patients with chronic lateral epicondylitis (tennis elbow).
Medical records will be reviewed to compare outcomes between patients treated in routine clinical practice with a 3-dose injection regimen (weeks 0, 2, and 4) plus a home exercise program and those treated with a home exercise program alone.
Key outcome measures include pain intensity (VAS), functional status (PRTEE), grip strength, and pressure pain threshold.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sivas, Turkey (Türkiye)
- Sivas State Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with chronic Lateral Epicondylitis who applied to the Physical Medicine and Rehabilitation outpatient clinic of Sivas State Hospital.
The study involves the retrospective analysis of patients treated between June 01, 2025, and November 01, 2025.
Description
Inclusion Criteria:
- Patients aged between 18 and 70 years.
- Patients diagnosed with Lateral Epicondylitis (LE).
- Presence of symptoms persisting for 6 weeks or longer.
- Patients who were treated with either a 3-dose protocol of Hyaluronic Acid + Amino Acid injection combined with a home exercise program, or a home exercise program alone.
Exclusion Criteria:
- History of rheumatic disease.
- History of malignancy.
- Presence of radiculopathy or neuropathy.
- Presence of peripheral circulatory disorders.
- Congenital or acquired upper extremity deformities.
- History of coagulopathy or current use of warfarin therapy.
- Presence of prosthesis, metal implant, or internal fixator in the elbow region.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control Group: Home Exercise Program Only
Home exercise program without injection.
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Standardized home exercise program for chronic lateral epicondylitis.
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Intervention Group: HA+AA Injection + Home Exercise Program
Patients in this retrospective cohort were treated with a targeted biological support injection (Hyaluronic Acid and Amino Acid combination) administered at weeks 0, 2, and 4, in addition to the standardized home exercise program.
|
Standardized home exercise program for chronic lateral epicondylitis.
3-dose injection protocol administered at weeks 0, 2, and 4.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Intensity (VAS)
Time Frame: Baseline, Week 4, and Month 3
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Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS).
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Baseline, Week 4, and Month 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pressure Pain Threshold (Algometry)
Time Frame: Baseline, Week 4, and Month 3
|
Pressure pain threshold over the common extensor tendon will be measured using a handheld algometer.
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Baseline, Week 4, and Month 3
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Change in Functional Status (PRTEE Score)
Time Frame: Baseline, Week 4, and Month 3
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Functional disability and pain will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE).
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Baseline, Week 4, and Month 3
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Change in Grip Strength (Hand Dynamometer)
Time Frame: Baseline, Week 4, and Month 3
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Grip strength will be measured using a hand-held dynamometer.
Measurements will be recorded in kilograms (kg).
Higher values indicate greater strength.
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Baseline, Week 4, and Month 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2025
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
February 7, 2026
First Submitted That Met QC Criteria
February 7, 2026
First Posted (Actual)
February 13, 2026
Study Record Updates
Last Update Posted (Actual)
February 13, 2026
Last Update Submitted That Met QC Criteria
February 7, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HA+AA-LE-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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