Periosteal Electrical Dry Needling With no Maintenance Treatments vs. Maintenance Treatments Every Other Month vs. Maintenance Treatments Once Per Month for Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 586
- 试验地点
- 2
- 主要终点
- Change in WOMAC Knee Osteoarthritis Index (Total Score)
研究概览
简要总结
The purpose of this research is to treat patients with knee osteoarthritis (OA) with periosteal electric dry needling (PEDN). It is also to determine the optimal "maintenance" regiment (i.e. maintenance treatments, one maintenance treatment every other month, or one maintenance treatment per month) required to maintain improvements in pain and function following PEDN. Physical therapists commonly use PEDN to treat knee OA, and previous studies suggest that this treatment is useful for reducing pain and improving function in patients with osteoarthritis. However, an appropriate maintenance treatment strategy to maintain these outcomes is presently unknown.
详细描述
Patients with knee osteoarthritis will be randomized to receive periosteal electrical dry needling 1-2 treatments per week for 6 weeks (up to 10 sessions total) followed by either: 1. no maintenance treatments, 2. one maintenance treatment every other month or 3. one maintenance treatment per month.
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
- •Adult over the age of 18 years old:
- •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) (sensitivity = 95% / specificity = 69%)
- •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 physical therapy, massage therapy, chiropractic treatment, or injections for knee pain in last 4 weeks.
- •History of a partial or total knee replacement on the painful lower extremity.
- •History of a surgical procedure on either lower extremity in last 12 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 periosteal electric dry needling
- •The patient is pregnant.
结局指标
主要结局
Change in WOMAC Knee Osteoarthritis Index (Total Score)
时间窗: baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks
24 questions each worth 0-4 points with maximum score of 96 points possible. The greater the score, the worse the symptoms of knee OA
次要结局
- Change in knee pain(baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks)
- Change in Medication Intake (Frequency of medication intake during last time period)(baseline, 30 weeks)
- Change in WOMAC Knee Osteoarthritis Index (Pain)(baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks)
- Change in WOMAC Knee Osteoarthritis Index (Stiffness)(baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks)
- Change in GROC (Global Rating of Change score)(6 weeks, 14 weeks, 22 weeks, 30 weeks)
- Change in WOMAC Knee Osteoarthritis Index (Physical Function)(baseline, 6 weeks, 14 weeks, 22 weeks, 30 weeks)
研究者
James Dunning, DPT, MSc, FAAOMPT
Principal Investigator
Alabama Physical Therapy & Acupuncture