Effects of 9 Points Electrical Dry Needling on Pain, Range of Motion, Function and Quality of Life in Patients With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
The study will be conducted to compare effects of 9 points electrical dry needling along with standard physical therapy and standard physical therapy alone in knee osteoarthritis patients.
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
- Double (Participant, 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
- •participants age group from 40-60 years
- •Both male and female genders
- •Knee osteoarthritis (OA) confirmed by radiographic evidence (Kellgren- Lawrence grade 3).
- •Numerical Pain Rating Scale (NPRS) ≥ 4/
- •Able to stand and bear weight on affected knee.
- •WOMAC score > 25 moderate level of difficulty performing ADL
- •Participant with restricted range of motion
- •Pain while walking and ascending stairs
- •Patients volunteered to participate in the study and signed informed consent
排除标准
- •Mild to severe knee osteoarthritis (Kellgren-Lawrence grade 2 or 4).
- •Recent knee surgery or injection (<6 months).
- •Knee instability and ligamentous injury.
- •Pregnancy and breastfeeding.
- •Patient with needle phobia and with history of abnormal reaction to needles.
- •Diagnosed psychological disorders
- •Anticoagulant patient, tumors and hematomas.
- •All acute emergencies and acute systematic fevers.
- •Pacemakers and implantable cardioverter defibrillators
研究组 & 干预措施
Experimental : 9 points electrical dry needling along with standard physical therapy
3 times per week for 6 weeks
干预措施: 9 points electrical dry needling (Other)
Experimental : 9 points electrical dry needling along with standard physical therapy
3 times per week for 6 weeks
干预措施: Standard physical therapy (Other)
active comparator: standard physical therapy
3 times per week for6 weeks
干预措施: Standard physical therapy (Other)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: from enrollment to the end of 6 week
Numeric Pain Rating Scale (NPRS) measures subjective pain intensity using an 11-point numeric scale (0-10) where 0 = "no pain" and 10 = "worst pain imaginable". Patients verbally or mark on a horizontal line the whole number best reflecting current pain severity, typically assessing "current pain," "worst pain," "least pain," or "average pain" over the prior 24 hours. Mild pain = 1-3, moderate pain = 4-6, severe pain = 7-10 guides clinical decision-making. changes in NPRS scale will be measured baseline and at the end of 6 week.
Goniometer measures joint range of motion (ROM)
时间窗: from enrollment to the end of 6 week
Goniometer: Precision instrument measuring joint range of motion (ROM) in degrees using protractor body with two arms (stationary and movable) aligned to anatomical bony landmarks spanning the joint axis. Primary Use: Quantifies active (AROM) and passive (PROM) joint excursion for objective baseline, progress tracking, and impairment rating. Universal goniometer most common; digital/smartphone apps offer improved reliability (ICC \>0.9 vs 0.74-0.91 traditional). Reliability: Long-arm \> short-arm (MSD 6° vs 10°); inter/intra-rater ICC 0.84-0.99 with standardized technique. changes in knee flexion and extension ROM will be measured baseline and at the end of 6 week.
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
时间窗: from enrollment to the end of 6 week
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a validated, disease-specific patient-reported outcome measure for hip/knee osteoarthritis assessing pain (5 items, 0-20), stiffness (2 items, 0-8), and physical function (17 items, 0-68) over past 48 hours. Scoring: Likert 0-4 scale per item (0=None, 4=Extreme); higher total scores (0-96) indicate worse symptoms. MCID: 12% improvement (\~9-12 points) represents clinically meaningful change. changes in WOMAC score will be measured baseline and at the end of 6 week.
EQ-5D 3L (QUALITY OF LIFE)
时间窗: From enrollment to the end of 6 week
EQ-5D-3L is developed by EuroQol groups is standardized instrument for measurement of health-related quality of life. it administers strong test-retest reliability for knee OA which of 0.73 to 0.91. Changes in EQ-5D 3L will be measured at baseline and at 6 weeks.
次要结局
未报告次要终点