跳至主要内容
临床试验/CTRI/2025/04/084605
CTRI/2025/04/084605招募中不适用

To Determine the effect of selective Acupuncture points among the individuals with Osteoarthritis of knee -A Randomized Controlled Trial

Dr V Ashtalakshmi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月23日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Assessment of WOMAC (Western Ontario and Mcmaster universities Arthritis osteoarthritis index) scale

研究概览

简要总结

Osteoarthritis is a chronic degenerative disorder of multifactorial aetiology characterized by the loss of articular cartilage, hypertrophy of bone at the margins, subchondral sclerosis, and range of biochemical changes and morphological alterations of the synovial membrane and joint capsule. Worldwide about 10–15% of all adults aged over 60 have some degree of osteoarthritis. While the global prevalence of knee & hip osteoarthritis was 3.8% and 0.85% respectively. India’s elderly population (>60 yrs) is set to increase drastically from around 7.4% in 2001 to around 19% in 2050. Several studies have suggested the potential benefits of acupuncture to generally improve symptoms such as joint pain, swelling and stiffness in osteoarthritis of knee. A Randomized controlled trial will be adopted for this study. The simple randomization method with 1:1 ratio will be done for 60 subjects get a sample size of (n=30) in each group. After obtaining informed consent, participants who fit the inclusion criteria will be randomly allocated into GROUP A (study group) GROUP B (control group). GROUP A will receive selective Acupuncture points at GB-31(FENGSHI), GB-34(YANGLINGQUAN), GV-20(BAIHUI), EX-LE-2(HEDING), EX-LE-5 (MEDIAL XIYAN & LATERAL XIYAN), to the affected knee for 20 minutes, three days per week and for 5 weeks. While the GROUP B (control group) will receive sham acupuncture for 20 minutes to the affected knee, thrice a week for 5 weeks. As a primary assessment WOMAC Scale is used to measure the difficulties in daily activities of the osteoarthritis patients at baseline and 5th week. As a Secondary outcome the range of motion of knees will be measured using the Goniometer on baseline and at 5th week.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Both male and female patients of age group 50 to 65 years already diagnosed with osteoarthritis of knee for more than 6 months and willing to give consent for study are included.

排除标准

  • people with other types of arthritis, congenital deformities, hairline fractures and fractures of knee.
  • Patient with needle phobia and mentally unstable are excluded for the study.

结局指标

主要结局

Assessment of WOMAC (Western Ontario and Mcmaster universities Arthritis osteoarthritis index) scale

时间窗: Baseline and 5 weeks

次要结局

  • Assessment of Range of Motion of knee with Goniometer Scale(Baseline and 5 weeks)

研究者

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

Dr V Ashtalakshmi

International Institute of Yoga and Naturopathy Medical Sciences

研究点 (1)

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