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临床试验/NCT06869317
NCT06869317已完成不适用

The Effects of Sheep Ghee on Pain, Stiffness, Physical Function, and Range of Motion of the Knee Joint in Older People With Osteoarthritis of the Knee

Rafsanjan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
1
主要终点
Pain Level Assessment

研究概览

简要总结

  • The goal of this clinical trial is to learn if treatment with sheep ghee can improve stiffness, pain, range of motion, and physical function in adults with knee joint issues.
  • The main questions it aims to answer are:

i. Does sheep ghee treatment reduce knee stiffness? ii. Does it decrease knee pain? iii. Does it improve range of motion? iv. Does it enhance physical function?

  • Researchers will compare the group receiving sheep ghee treatment to a control group to see if there are significant improvements in knee joint health. Additionally, the placebo group receiving vaseline will be compared to the intervention group.

  • Participants will:

  • Receive a sheep ghee and vaseline treatment for their knee joint.

  • Complete assessments of their stiffness, pain, range of motion, and physical function.

详细描述

Overview:

This clinical trial aims to investigate the therapeutic potential of sheep ghee in alleviating knee joint problems among adults. Given the rising interest in alternative treatments for musculoskeletal conditions, this study focuses on whether sheep ghee can effectively improve knee stiffness, reduce pain, enhance the range of motion, and improve overall physical function in participants suffering from knee joint issues.

Objectives:

The primary objective of this clinical trial is to assess the following key questions regarding the effectiveness of sheep ghee treatment:

Does sheep ghee treatment reduce knee stiffness?

研究设计

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

入排标准

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

入选标准

  • •Participants with no injury, open wound or skin disease in the knee; no recent injury to the affected knee; no alcohol or drug addiction; no use of other complementary methods, such as physiotherapy, acupuncture or percutaneous electrical nerve stimulation; no history of knee surgery and insensitivity to Vaseline and sheep ghee; no mental illness or cognitive disorder; ability to see and walk; ability to communicate; mild to moderate pain score on the Visual Analogue Scale (VAS), and no history of intra-articular corticosteroid or hyaluronic acid injection for the past three months were included in the study

排除标准

  • •Patients who were dissatisfied, had moderate to severe local sensitivity to ghee, forgot to use the ghee or Vaseline more than twice in the intervention and placebo groups, and used less than two-thirds of the drug container during the study were excluded from the study

研究组 & 干预措施

Sheep ghee

Experimental

To evaluate the efficacy of sheep ghee as a therapeutic agent for improving knee joint health in participants experiencing osteoarthritis or related joint issues. The intervention group one gram (equivalent to a small ice cream spoon) of sheep ghee was applied to painful areas (front, side, and back) of the knee twice a day in the morning and at night for one month.

干预措施: Sheep ghee (Other)

vaseline

Placebo Comparator

.The placebo group received Vaseline the same way as the intervention group did at equal doses.

干预措施: Sheep ghee (Other)

control

No Intervention

The control group received only one-minute of massage.

结局指标

主要结局

Pain Level Assessment

时间窗: Before and immediately after intervention

Pain levels will be measured using the Visual Analog Scale (VAS), a validated tool where participants indicate their pain intensity on a scale from 0 (no pain) to 10 (worst possible pain).

Joint Mobility Assessment

时间窗: before and immediately after intervention

The range of motion for knee flexion (heel to thigh distance)

Assessment of the condition of patients with osteoarthritis of the knee, including pain, stiffness, and physical functioning of the joints.

时间窗: before and immediately after intervention

The WOMAC, a questionnaire used to assess hip and knee osteoarthritis measures three subscales on a Likert scale (None, mild, moderate, severe, extreme): 1- an assessment of knee pain in the previous 48 hours, 2- joint stiffness, and 3- physical function in the last 48 hours.

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

Fatemeh Harandi

first author

Rafsanjan University of Medical Sciences

研究点 (1)

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