Dry Needling Versus Conventional Physical Therapy in Patients With Knee Osteoarthritis: a Multi-center Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change in Knee Pain Intensity (NPRS)
研究概览
简要总结
The purpose of this research is to compare the effectiveness of conventional physical therapy (manual physical therapy, exercise, range of motion, and stretching) versus conventional physical therapy combined with dry needling in patients with knee osteoarthritis (OA). Physical therapists commonly use conventional physical therapy techniques and dry needling to treat knee OA, and this study is attempting to find out if the addition of dry needling to conventional physical therapy has an equal, greater, or lesser effect than conventional physical therapy alone.
详细描述
Patients with knee OA will be randomized to receive 1-2 treatments per week for 6 weeks (up to 10 sessions total) of either: (1) Dry Needling and conventional physical therapy or the (2) Conventional physical therapy (manual physical therapy, exercise, range of motion and stretching)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Report of knee pain of at least 2/10 per NPRS (0---10 scale) for >3 months
- •Report of at least 3 of the following per Altman et al. (1986)
- •Over 50 Years of age
- •Less than 30 minutes of morning stiffness
- •Crepitus on active motion
- •Bony tenderness
- •Bony enlargement
- •No palpable warmth of synovium
排除标准
- •Report of red flags to manual physical therapy to include: hypertension, infection, diabetes, peripheral neuropathy, heart disease, stroke, chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
- •History of previous surgery to the knee
- •History of physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in the last 4 weeks
- •History of a surgical procedure on either lower extremity in last 6 months
- •Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
- •Weakness involving a major muscle group of the lower extremity.
- •Diminished patella or achilles tendon reflex
- •Diminished or absent sensation to pinprick in lower extremity dermatome
- •Involvement in litigation or worker's compensation regarding knee pain.
- •Any condition that might contraindicate the use of electro-needling
- •The patient is pregnant.
结局指标
主要结局
Change in Knee Pain Intensity (NPRS)
时间窗: Baseline, 2 Weeks, 6 Weeks, 3 Months
Change in Knee Osteoarthritis Index (Pain)
时间窗: Baseline, 2 Weeks, 6 Weeks, 3 Months
5 Questions each worth 0-4 points with a maximum score of 20 points possible
Change in Knee Osteoarthritis Index (Stiffness)
时间窗: Baseline, 2 Weeks, 6 Weeks, 3 Months
2 Questions each worth 0-4 points with a maximum score of 8 points possible
Change in Knee Osteoarthritis Index (Physical Function)
时间窗: Baseline, 2 Weeks, 6 Weeks, 3 Months
17 Questions each worth 0-4 points with a maximum score of 68 points possible
Change in Knee Osteoarthritis Index (Total)
时间窗: Baseline, 2 Weeks, 6 Weeks, 3 Months
24 Questions each worth 0-4 points with a maximum score of 96 points possible
次要结局
- Change in Global Rating of Change Score (GROC)(2 Weeks, 6 Weeks, 3 Months)
- Change in Medicine Intake (Frequency of medication intake)(Baseline, 3 months)
研究者
James Dunning, DPT, MSc, FAAOMPT
DPT MSc FAAOMPT
Alabama Physical Therapy & Acupuncture