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临床试验/NCT06034106
NCT06034106Enrolling By Invitation不适用

The Effect of Pomegranate (Punica Granatum L.) Peel Compress Application on Pain and Physical Function Status in Patients With Knee Osteoarthritis

TC Erciyes University2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2023年4月14日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
67
试验地点
2
主要终点
WOMAC Osteoarthritis Index

研究概览

简要总结

Osteoarthritis is the most common type of arthritis among rheumatologic diseases. Complementary therapies are one of the effective methods for pain control. This study was planned as a randomized controlled experimental study. For this purpose, patients diagnosed with knee osteoarthritis who applied to the Orthopedics Outpatient Clinic will be included. It was calculated that the study would include at least 67 patients. The study will be collected using patient information form, descriptive characteristics form, Visual Analog Scale (VAS) and WOMAC osteoarthritis application scale. It was planned as a randomized controlled experimental study to evaluate the effect of pomegranate peel (P. granatum) compress application on pain and function status. The study was divided into 3 groups as Pomegranate (Punica granatum) peel compress, hot compress and control group. Pomegranate (Punica granatum) peel compress was applied 3 days a week for 3 weeks by turning the powder into porridge check.

详细描述

This randomized controlled experimental study was conducted to evaluate the effect of pomegranate (Punica granatum) peel compress application on pain, stiffness and physical function in individuals with knee osteoarthritis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Visual analog scale score of 3 and above,
  • those aged 45 and over,
  • Diagnosed with knee OA by a physician according to the criteria of the American - Rheumatology Association (ARD),
  • pain lasting at least 1 month or longer,
  • not included in any physical therapy program during the research period, a
  • capable of answering research questions,
  • agreeing to participate in the research by giving verbal and written consent

排除标准

  • with a defined psychiatric illness,
  • having vision and hearing problems,
  • diagnosed with complex disease such as malignant,
  • having a wound in the application area,
  • with a diagnosed vascular disease,
  • the patient's other inflammatory disease such as rheumatoid arthritis, gout, fibromyalgia
  • who have had serious trauma or surgery in the last 6 months,
  • who have received DMARDS or intra-articular steroid injection therapy in the last 3 months

结局指标

主要结局

WOMAC Osteoarthritis Index

时间窗: The scale was filled in the baseline

The WOMAC index is composed of 24 items and 3 subdimensions (pain, stiffness, and physical function). The participants are asked to rate pain (5 questions), stiffness (2 questions), and difficulties encountered in physical functioning (17 questions) during the day (24 hours). The index is a 5-point Likert-type scale, where 0 is none, 1 mild, 2 moderate, 3 severe, and 4 very severe. Pain scores range from 0e20 points, stiffness scores from 0e8 points, and difficulties in physical function scores from 0e68 points. Higher scores indicate increased pain and stiffness, impairment in physical functioning, and higher levels of physical limitation.

Visual Analog Scale

时间窗: The scale was filled in the baseline

A VAS consisting of a 10-centimeter horizontal line, anchored evenly by numbers from 0 to 10, was used to assess the patient's pain and willingness to repeat the procedure. The number 0 was identical to having no pain while the number 10 corresponded to maximal pain that can be experienced by the patient

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilek Efe Arslan

ErciyesU

TC Erciyes University

研究点 (2)

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