跳至主要内容
临床试验/CTRI/2025/05/087634
CTRI/2025/05/087634尚未招募不适用

Efficacy of Blood flow restriction training and Russian current in conjugation with Resistance training in alleviating symptoms in early knee osteoarthritis:A Randomised controlled trial

Uttar Pradesh University Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2025年4月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
114
试验地点
1
主要终点
Pain intensity,Range of motion, muscle strength,functional disability.

研究概览

简要总结

This randomized controlled trial investigates the comparative efficacy of Blood Flow Restriction Training (BFRT) and Russian current therapy, each combined with resistance training and a home exercise program, in patients with early knee osteoarthritis (OA). Participants aged 45–70 years with Grade 1 or 2 knee OA (per Kellgren-Lawrence classification) will be recruited from the Orthopaedics OPD at UPUMS, Safai. A total of 114 participants will be randomly assigned to two groups (n=57 each) using computer-generated randomization.

Intervention Protocols: Group A will receive BFRT with resistance training, performed three times per week for 4 weeks, using pressure based on Australian Sports Commission guidelines. Group B will receive Russian current (50 Hz, 15 mins) with similar resistance training. Both groups will also follow a standardized home exercise program including quadriceps drills, hamstring curls, and stretching, with hot fomentation post-exercise.

Outcome Measures: Baseline and post-intervention assessments at 4 weeks and 2-week follow-up will include pain (NRS, algometer), range of motion (digital goniometer), muscle strength (MMT), and functional disability (WOMAC). Validity and reliability of all outcome tools are well-established.

Statistical Analysis: Data will be analyzed using SPSS software. Independent t-tests and ANOVA will determine the significance of differences between groups.

Hypothesis: The alternative hypothesis suggests a significant difference in outcomes between BFRT and Russian current interventions, while the null hypothesis posits no significant difference.

Novelty: This study is novel in its direct comparison of BFRT and Russian current combined with resistance training in early knee OA. It emphasizes early-stage intervention, integrates both objective and subjective outcomes, and has the potential to inform clinical guidelines for preventive OA management.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
45.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Age group: 45 to 70 yrs
  • Patient with both unilateral and bilateral knee pain.
  • Patients in early phase: Grade 1 and 2, According to Kellgren Lawrence classification 4.No contraindication to physical activity or electrical stimulation.
  • Both male and Female.

排除标准

  • Metabolic bone disorders.
  • Use of corticosteroids or local injections for knee OA in past 6 months.
  • Skin diseases.
  • 4.Patient with cardiovascular diseases.
  • 6.Patients with bony ankylosis.
  • 7.Neuropathic joint diseases.
  • History of trauma.

结局指标

主要结局

Pain intensity,Range of motion, muscle strength,functional disability.

时间窗: At Baseline,at 4 weeks and 8 weeks.

次要结局

未报告次要终点

研究者

申办方类型
Other [Government Medical University]

研究点 (1)

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