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Clinical Trials/NCT07410663
NCT07410663Active, not recruitingNot Applicable

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

Sivas State Hospital1 site in 1 country60 target enrollmentStarted: December 1, 2025Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Change in Pain Intensity (VAS)

Study Overview

Brief 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). 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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: Home Exercise Program (Behavioral)

Control Group: Home Exercise Program Only

Home exercise program without injection.

Intervention: Home Exercise Program (Behavioral)

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.

Intervention: Hyaluronic Acid + Amino Acid Injection (Drug)

Outcomes

Primary Outcomes

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

  • Change in Pressure Pain Threshold (Algometry)(Baseline, Week 4, and Month 3)
  • Change in Functional Status (PRTEE Score)(Baseline, Week 4, and Month 3)
  • Change in Grip Strength (Hand Dynamometer)(Baseline, Week 4, and Month 3)

Investigators

Sponsor
Sivas State Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Serkan Polat

MD

Sivas State Hospital

Study Sites (1)

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