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临床试验/NCT06875817
NCT06875817招募中不适用

Effects of Feldenkrais Exercises on Pain, Range of Motion, and Disability in Patients With Knee Osteoarthritis

Riphah International University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Numeric Pain Rating Scale

研究概览

简要总结

The primary objective of the study is to determine the effects of Feldenkrais Exercises on Pain, Range of Motion, and Disability in Patients with Knee osteoarthritis. Knee osteoarthritis poses significant challenges in pain management, mobility improvement, and disability reduction among middle-aged to older adults. Feldenkrais Method offers benefits comparable to back school lessons or core stability exercises. This study, conducted as a Randomized Controlled Trial at RIPHAH Rehabilitation Clinic, aims to assess the efficacy of Feldenkrais exercises compared to conventional physical therapy in addressing pain, range of motion, and disability in knee osteoarthritis patients aged 40-60 years. A non-probability convenience sampling method will recruit 32 participants meeting specific criteria for osteoarthritis severity and functional ability. Participants will be randomly assigned to Group A (Feldenkrais exercises) or Group B (conventional therapy), with interventions delivered over four weeks. Group A will engage in Feldenkrais exercises targeting pelvic and lower limb mobility, while Group B will receive standard treatments including knee isometrics, mobilization, transcutaneous electric nerve stimulation, and heating pad applications. Pain severity will be measured using the Numeric Pain Rating Scale, Range of Motion assessed via goniometry, and disability evaluated using the Western Ontario McMaster Universities Osteoarthritis Index. Statistical analysis using SPSS will compare outcomes between groups at baseline, post-treatment, and follow-up assessments.

详细描述

Osteoarthritis (OA) is one of the most prevalent rheumatic diseases in the elderly, being a frequent cause of incapacity among this population. It is more common in the knee and is characterized by pain, stiffness, and function loss. OA is a major public health problem. The prevalence of knee OA is 34-45% in the Indian population with clinical symptoms of pain, reduced muscle strength, and knee function. That is the most common form of degenerative joint disease affecting 15 to 40% of people aged 40 and above. One hundred fifty-one million people worldwide experienced OA, and it was ranked sixth as a leading cause of moderate and severe disability. The knee is the joint most frequently affected by osteoarthritis. The Feldenkrais Method has the potential to help older people with OA. Developed by Dr. Moshe Feldenkrais, the method is a gentle form of exercise which has been shown to be acceptable for older people who have limited movement. The Feldenkrais Method is taught in two parallel forms, Awareness Through Movement (conducted as a group exercise) and Functional Integration (one-on one approach). This study explores the effectiveness of Awareness Through Movement lessons in helping older people with OA. The method aims for improved functioning, where the entire body cooperates efficiently with minimal effort. This study aims to explore the potential benefits of Feldenkrais exercises as an alternative, non-invasive treatment for knee osteoarthritis. Medical conventional treatments for knee OA, such as pharmacotherapy and surgical interventions, often come with limitations including potential side effects, high costs, and sometimes limited long-term effectiveness. These constraints necessitate the exploration of alternative, non-invasive treatment options that can be both effective and accessible. Feldenkrais exercises focus on improving movement patterns and body awareness, which may help reduce pain, enhance range of motion, and decrease disability.

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
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 40 to 60 years of patients.
  • •Both female and male
  • •Able to walk for 6 minutes (Timed up-and-go test)
  • •Able to rise from floor
  • •Grade 2 and 3 of osteoarthritis diagnosed with radiograph (Kellgren and Lawrence classification system)
  • •Pain reported on VAS score ˃6/10 in knee region for more than 3 months

排除标准

  • •• Tuberculosis, carcinoma, heart disease, and osteoporosis
  • •Any trauma or localized infection in the knee joint
  • •Hyper flexibility
  • •Open sores
  • •Ongoing radiotherapy, chemotherapy, steroid therapy, or anticoagulants
  • •Psychiatric diseases such as phobia/obsession and depression
  • •Allergy to hot pack
  • •Patients with a history of surgery in the knee region within a year.
  • •Severe cognitive impairments
  • •Contraindications to physical activity
  • •Concurrent participation in other physical therapy programs

研究组 & 干预措施

Group-A (Feldenkrais exercises)

Experimental

This group of participants will engage in Feldenkrais exercises focused on pain, improved mobility, and disability. Each session will last 30 minutes, conducted twice a week for 4 weeks. The exercises include Pelvic Clock Exercise, Knee Rolling, Ankle Circles, Knee Flexion and Extension and Leg Slides.

干预措施: Feldenkrais exercises (Other)

Group-B (Standard Physicaltherapy interventions)

Active Comparator

Participants will receive standard physical therapy interventions for knee osteoarthritis.

Protocol:

  • Knee Isometrics: Isometric exercises targeting the quadriceps and hamstrings, performed for 10 minutes, twice a week.
  • Knee Mobilization
  • Transcutaneous Electric Nerve Stimulation (TENS).
  • Heating Pad Duration: 30-minute sessions, conducted twice a week for 4 weeks.

干预措施: Standard physical therapy interventions (Other)

结局指标

主要结局

Numeric Pain Rating Scale

时间窗: upto 4 weeks

The NPRS is a segmented numeric scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. NPRS is anchored by terms describing pain severity extremes.

Western Ontario and McMaster Universities Arthritis Index (WOMAC)

时间窗: upto 4 weeks

WOMAC is a disease-specific measure of health status (pain, stiffness, and function) in OA sufferers. It is widely used for evaluating hip and knee osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales

Universal Goniometer (UG)

时间窗: upto 4 weeks

A universal goniometer is a crucial tool in orthopedics used to precisely measure joint angles. It exists in two primary forms: the short-arm version is ideal for smaller joints such as the wrist, elbow, or ankle, while the long-arm version is more accurate for joints with longer levers like the knee and hip. It highlighting its role in quantifying joint mobility and aiding in treatment planning and assessment in medical practice.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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