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临床试验/NCT06345222
NCT06345222已完成不适用

Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain

Bursa Yuksek Ihtisas Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 65 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
2
主要终点
change in knee pain with prolotherapy application

研究概览

简要总结

92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. When creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. Patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. However, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. Prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. In the control group, existing medical treatments were continued and no injection procedure was performed. Before the research, all participants were evaluated with Case Report Form, Visual Analog Scale (VAS) and Quality of Life Scale Short Form (SF-36). The cases in the experimental and control groups were re-evaluated with the VAS and SF-36 scales at the first month.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who suffer from primary knee osteoarthritis

排除标准

  • Inflammatory knee pain
  • Cellulitis
  • Septic arthritis
  • Local abscess
  • Bleeding disorders
  • Patient on anticoagulant medication
  • Patients allergic to dextrose
  • Diabetes Mellitus
  • breathing problems
  • Electrolyte imbalance
  • Kidney or liver disease

结局指标

主要结局

change in knee pain with prolotherapy application

时间窗: 1 month

Visual Analog Scale (VAS) scores determines pain relief. VAS scale use numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain you have ever felt.

change in quality of life

时间窗: 1 month

The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.SF-36 Scale scores determines change in quality of life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

次要结局

未报告次要终点

研究者

发起方
Bursa Yuksek Ihtisas Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Hakan Demirci

Professor

Bursa Yuksek Ihtisas Training and Research Hospital

研究点 (2)

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