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临床试验/CTRI/2024/04/066230
CTRI/2024/04/066230尚未招募不适用

Effects of lateral wedge insole versus lateral wedge with medial arch support insole on pain, functional activities and joint space reduction in tibiofemoral osteoarthritis of knee

Arpitha D1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
WOMAC

研究概览

简要总结

osteoarthritis is a chronic degenerative condition characterized by bone remodeling and articular cartilage loss patients with osteoarthritis mainly complains of pain joint stiffness ,functional impairments intensity of symptoms vary from patients to patients .one of the initial steps in the diagnosis of osteoarthritis is joint space narrowing  less space restricts joints range of motion .resulting in stiffness and increases stress on joint

recent research confirms the link between knee and foot problems in people with knee osteoarthritis ,on examination it is showed that 25% people reported pain in the foot and during dynamic walking the effect of genu varum is causing subtalar joint pronation during loading and propulsive phase of gait

numerous research have hypothesized that changing ones footwear can reduce pressure on the medial knee joint which in turn reduce pain and enhance functional status .but there is lack of evidence on comparison of effects of lateral wedges with medial arch support and lateral heel rise therefore the need of this study to compare to different footwear modification along with physiotherapy treatment in osteoarthritis patients

here in my study we are including 60 patients from 40 - 80 years both male and female with grade 2 and grade 3 osteoarthritis based on x-ray and patients with genu varum and allocating them into two different groups group A and group B  and assessing pain ,joint space, range of motion, muscle strength, functional ability on WOMAC  on day one and after 8 weeks

group A will receive lateral wedge with medial arch support and group B will receive lateral heel rise only  and data will be analyzed using statistical t test comparing baseline and post intervention

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Age group 40 -80
  • Early to midstage (KL grade 2-3) OA of the medial compartment of the knee based on recent X-RAY 2.Subjects able to walk independently 3.Average knee pain of at least 3 out of 10(using VAS) ï‚· Either of the gender ï‚· Bilateral osteoarthritis of knee ï‚· Subjects with varus deformity of knee.

排除标准

  • knee surgery or intra articular injections for pain 1.History of knee joint replacement or tibial osteotomy
  • Foot or ankle problems that contraindicated the use of footwear load modifying interventions 3.Relevant ligamentous instability 4.Relevant OA of lateral compartment of knee based on X-ray
  • History of fracture in the of area knee joint which is under the study
  • Any major lower limb surgery in the past 7.Locomotion with assistive device 8.Neurological disorders such as stroke 9.Grade 4 of KL classification 10.Cardiac and respiratory conditions.

结局指标

主要结局

WOMAC

时间窗: baseline and after 8weeks

VAS

时间窗: baseline and after 8weeks

joint space measurement

时间窗: baseline and after 8weeks

Range of motion

时间窗: baseline and after 8weeks

次要结局

  • Range of motion(muscle strength)

研究者

发起方
Arpitha D
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Arpitha D

Shri Dharmasthala Manjunatheshwara College of Physiotherapy

研究点 (1)

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