NCT07410663

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 7, 2026

Last Update Submit

February 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Intensity (VAS)

    Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS).

    Baseline, Week 4, and Month 3

Secondary Outcomes (3)

  • 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

Study Arms (2)

Control Group: Home Exercise Program Only

Home exercise program without injection.

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.

Drug: Hyaluronic Acid + Amino Acid InjectionBehavioral: Home Exercise Program

Interventions

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

Intervention Group: HA+AA Injection + Home Exercise Program

Standardized home exercise program for chronic lateral epicondylitis.

Control Group: Home Exercise Program OnlyIntervention Group: HA+AA Injection + Home Exercise Program

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas State Hospital

Sivas, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Hyaluronic AcidAmino Acids

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydratesAmino Acids, Peptides, and Proteins

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

December 1, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations