Lateral EpicondylitisNCT07410663
Hyaluronic Acid and Amino Acid Combination Versus Exercise for Chronic Lateral Epicondylitis
An observational study of Lateral Epicondylitis, run by Sivas State Hospital at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Hyaluronic Acid + Amino Acid Injection and Home Exercise Program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 May 2026
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- Hyaluronic Acid + Amino Acid Injection, Home Exercise Program
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid + Amino Acid InjectionDrug
3-dose injection protocol administered at weeks 0, 2, and 4.
Home Exercise ProgramBehavioural
Standardized home exercise program for chronic lateral epicondylitis.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Home Exercise Program Only | Home exercise program without injection. Receives: Behavioral: Home Exercise Program | |
| 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. Receives: Drug: Hyaluronic Acid + Amino Acid Injection; Behavioral: Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (VAS)
Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS).
Measured: Baseline, Week 4, and Month 3
Secondary outcomes (3)
Change in Pressure Pain Threshold (Algometry)
Pressure pain threshold over the common extensor tendon will be measured using a handheld algometer.
Measured: Baseline, Week 4, and Month 3
Change in Functional Status (PRTEE Score)
Functional disability and pain will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE).
Measured: Baseline, Week 4, and Month 3
Change in Grip Strength (Hand Dynamometer)
Grip strength will be measured using a hand-held dynamometer. Measurements will be recorded in kilograms (kg). Higher values indicate greater strength.
Measured: Baseline, Week 4, and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Dec 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sivas State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Polat, Sivas State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410663
- Sponsor's protocol ID
- HA+AA-LE-001
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 13 Feb 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 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07410663
- Acronym / sponsor ID
- HA+AA-LE-001
- Conditions
- Lateral Epicondylitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sivas State HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 13 Feb 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Home Exercise Program Only | – | Behavioral: Home Exercise ProgramHome exercise program without injection. |
| Intervention Group: HA+AA Injection + Home Exercise Program | – | Drug: Hyaluronic Acid + Amino Acid Injection, Behavioral: Home Exercise ProgramPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- History of rheumatic disease.
- History of malignancy.
- Presence of radiculopathy or neuropathy.
- Presence of peripheral circulatory disorders.
- Congenital or acquired upper extremity deformities.
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 + Amino Acid Injection3-dose injection protocol administered at weeks 0, 2, and 4. | Drug | Intervention Group: HA+AA Injection + Home Exercise Program |
| Home Exercise ProgramStandardized home exercise program for chronic lateral epicondylitis. | Behavioural | Control Group: Home Exercise Program Only, Intervention Group: HA+AA Injection + Home Exercise Program |
Primary outcome
Change in Pain Intensity (VAS)
Time frame: Baseline, Week 4, and Month 3
Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS).
3 secondary outcomes
Change in Pressure Pain Threshold (Algometry)
Time frame: Baseline, Week 4, and Month 3
Change in Functional Status (PRTEE Score)
Time frame: Baseline, Week 4, and Month 3
Change in Grip Strength (Hand Dynamometer)
Time frame: Baseline, Week 4, and Month 3
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 13 Feb 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Epicondylitis, run by Sivas State Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (VAS) (time frame: Baseline, Week 4, and Month 3). 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 13 Feb 2026.