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临床试验/CTRI/2024/12/077648
CTRI/2024/12/077648尚未招募不适用

Development and testing of an Evidence Based Physiotherapy Protocol for Subjects with Osteoarthritis Knee.

Dr Tanvi Banker1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年6月1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
130
试验地点
1
主要终点
➢ Kellgren Lawrance X-Ray score

研究概览

简要总结

Till date there is no standard protocol available which goes in sequential manner and focusing over multiple domains (e.g. rate of Structural changes, Pain, Central sensitization, Functionality, Proprioception, Flexibility, Disability, Sleep quality, Dynamic balance, Gait, Quality of life) for patients with OA knee. The traditional treatment plan which is being followed in clinics is not wholesome. Usually, it includes one or other therapy as an adjustive therapy which focuses over limited domains and patient never gets satisfied with traditional or traditional along with adjustive therapy. Being an academician, PG Guide and a physiotherapist- seeing OPD Patients and their expectations I found a research gap regarding standard sequential evidence-based protocol. So, need of the study is to establish a standard evidence based protocol which follows the particular chronological order according to mechanism of action and which can cover almost every domains  (e.g. rate of structural changes, pain, central sensitization, functionality, proprioception, flexibility, disability, functionality, Sleep quality, dynamic balance, gait, quality of life) which gets affected in OA knee.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient with primary OA knee as per Kellgren – Lawrence classification Grade 1,2,3
  • Body Mass Index less than 24.9 kg/m2
  • Age Between 40 years to 65 years
  • Both Male and Female
  • Both unilateral and bilateral OA knee
  • Patient with knee pain, crepitations, stiffness of joint.
  • Average knee pain on walking more than 3 on an 11-point scale
  • Person who knows Gujarati and English.

排除标准

  • 1.Any inflammatory arthritis 2.Participants who have taken intra-articular corticosteroid or hyaluronic injections within last 6 months 3.Participants who have undergone through any surgery related to same sided knee joint in last 6 months.
  • 4.Patients who have any ligamentous or meniscal injury 5.Medical condition that hampering safe participation in an exercise program.
  • 6.Unable to ambulate without assistive device.

结局指标

主要结局

➢ Kellgren Lawrance X-Ray score

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ Step test for balance

时间窗: Before intervention and at the end of the 4th week of intervention.

15

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ Proprioception for joint position sense

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ NPRS for pain

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ 30 seconds sit to stand test for functionality

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ WOMAC scale for disability

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ TAMPA scale for kinesiophobia

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ SF12 for quality of life

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ Pittsburgh quality index for sleep quality

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ Pressure pain threshold for central sensitization

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ Back saver sit and reach test for flexibility

时间窗: Before intervention and at the end of the 4th week of intervention.

➢ Gait determinant -Cadence

时间窗: Before intervention and at the end of the 4th week of intervention.

次要结局

  • ➢ TAMPA scale for kinesiophobia(➢ SF12 for quality of life)

研究者

发起方
Dr Tanvi Banker
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Tanvi Banker

SPB Physiotherapy college, Surat

研究点 (1)

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