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临床试验/NCT07410663
NCT07410663进行中(未招募)不适用

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 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
60
试验地点
1
主要终点
Change in Pain Intensity (VAS)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Home Exercise Program (Behavioral)

Control Group: Home Exercise Program Only

Home exercise program without injection.

干预措施: 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.

干预措施: Hyaluronic Acid + Amino Acid Injection (Drug)

结局指标

主要结局

Change in Pain Intensity (VAS)

时间窗: Baseline, Week 4, and Month 3

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

次要结局

  • 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)

研究者

发起方
Sivas State Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Serkan Polat

MD

Sivas State Hospital

研究点 (1)

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