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临床试验/NCT07329205
NCT07329205尚未招募不适用

Effects of Femoral Nerve Mobilization on Pain Intensity, Function, Quality of Life and Central Sensitization in Patients With Knee Osteoarthritis

Prince Sattam Bin Abdulaziz University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
pain intensity

研究概览

简要总结

Background: Knee osteoarthritis (KO) is considered as a cause of disability among the elderly, causing pain, reduced quality of life, and decreased functionality. There is a limited knowledge about using femoral nerve mobilization in treating patients with arthritic changes.

Objectives: This study will be designed to determine the efficacy of adding of femoral nerve mobilization on pain intensity, function, quality of life and central sensitization in patients with knee osteoarthritis Methods: Thirty patients (aged ≥50 years with KO Kellgren-Lawrence grades I-II) will be included in this study: Patients will randomly be assigned into two groups: group A will receive traditional physical therapy while group B will receive femoral nerve mobilization in addition to traditional physical therapy. Three sessions will be performed for four weeks by 3 session /week. Patients will be evaluated for pain intensity using the numerical rating scale (NRS), knee function by WOMAC scale, quality of life by 12-item Short Form Survey questionnaire (SF-12) and central sensitization by the Arabic version of central sensitization inventory (CSI).

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
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

入选标准

  • patients aged 50 years or older, diagnosed with KO according to theAmerican College of Rheumatology's criteria with knee pain, and grade I or II on the Kellgren-Lawrence radiographic scale

排除标准

  • individuals suffering from chronic conditions considered to be perpetuating factors (e.g., fibromyalgia)
  • those with conditions causing lower extremity pain
  • individuals who had taken analgesics within 24 h before evaluations
  • those who had undergone corticosteroid or local anesthetic infiltration in the year prior to the study or during the follow-up period
  • those using substances that could interfere with treatment
  • those with a previous diagnosis of neuropathy (lumbosacral plexus) or myopathy
  • those with contraindications to mobilization or exercise, and those with cognitive deficits (dementia, Alzheimer's).

研究组 & 干预措施

Control group

Active Comparator

Traditional physical therapy

干预措施: traditional physical therapy (Other)

Neural mobilization group

Experimental

traditional physical therapy plus femoral nerve mobilization

干预措施: traditional physical therapy (Other)

Neural mobilization group

Experimental

traditional physical therapy plus femoral nerve mobilization

干预措施: Femoral nerve mobilization (Other)

结局指标

主要结局

pain intensity

时间窗: after 4 weeks

The pain was assessed by the numerical rating scale (NRS) where zero indicating no pain and 10 indicating maximal pain

central sensitization

时间窗: after 4 weeks

The CSI is a validated questionnaire designed to identify symptoms associated with central sensitization. It has two components: Scale A assesses 25 common symptoms in individuals with central sensitization, resulting in a score ranging from 0 to 100. This score was interpreted as follows: subclinical (0-29), mild (30-39), moderate (40-49), severe (50-59), and extreme (60-100). Scale B, which is not scored, collects information on previous diagnoses of specific diseases

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

Mohammad Moustafa Aldosoukki Hegazy

assisstant professor , department of health and rehabilitation sciences, college of applied medical siences

Prince Sattam Bin Abdulaziz University

研究点 (1)

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