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NCT Number: NCT07410663

Hyaluronic Acid and Amino Acid Combination Versus Exercise for Chronic Lateral Epicondylitis

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Lateral Epicondylitis Arm Injuries Elbow Injuries Elbow Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Tennis Elbow Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sivas State Hospital

Sivas, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyaluronic Acid + Amino Acid Injection

Drug

3-dose injection protocol administered at weeks 0, 2, and 4.

Home Exercise Program

Behavioral

Standardized home exercise program for chronic lateral epicondylitis.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. Change in Functional Status (PRTEE Score)

    Time frame: Baseline, Week 4, and Month 3

    Functional disability and pain will be assessed using the Patient-Rated Tennis Elbow Evaluation (PRTEE).

  3. Change in Grip Strength (Hand Dynamometer)

    Time frame: Baseline, Week 4, and Month 3

    Grip strength will be measured using a hand-held dynamometer. Measurements will be recorded in kilograms (kg). Higher values indicate greater strength.

Sponsors and collaborators

Lead sponsor

Sivas State Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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