Effects of Genicular Nerve Block for Patients With Knee Osteoarthritis Who Have Neuropathic or Nociceptive Pain: A Double-Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Efficacy of genicular nerve block on neuropathic pain reduction in knee osteoarthritis
研究概览
简要总结
Genicular nerve block is a safe and effective therapeutic procedure for intractable pain associated with chronic knee osteoarthritis (OA). There is increasing support for the neuropathic component to the knee OA pain. Investigators proposed that targeting treatment to the underlying pain mechanism can improve pain management in knee OA. There is a debate on injectable solutions used in nerve blocks. Investigators aimed to investigate the efficacy of genicular nerve block and to determine which solution should be appropriate for patients with knee osteoarthritis who have neuropathic or nociceptive pain.
详细描述
The patients who participated in this study were selected from outpatients who attended our hospital for knee pain. These 90 patients were who matched the following criteria. All patients had knee pain for more than 3 months.
The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves. This method was used to inject a total of 6 mL of lidocaine or 6 mL dextrose or 6 mL saline at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves.
Pain was evaluated with Analog Analogue Scale (VAS), daily living activities with Western Ontario and McMaster Universities Arthritis Index (WOMAC), maximum distance walked with Lequesne Score, and neuropathic pain was evaluated with painDETECT inquiry form. Outcome measures were assessed at baseline and at 1st, 4th weeks, and 3rd months after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •knee pain for more than 3 month.
- •radiological tibiofemoral OA (Kellgren-Lawrence grade 2-4 )
排除标准
- •acute knee pain, prior knee surgery, other connective tissue diseases that affected the knee, serious neurological or psychiatric disorders, steroid or hyaluronic acid injection therapy during the previous 3 months, sciatic pain, patients with polyneuropathy, anticoagulant medication use, pacemaker use, prior electroacupuncture treatment and physical treatment.
研究组 & 干预措施
Genicular nerve block with lidocaine
The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves.10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 6 mL of a solution containing 6 mL of 2% lidocaine or 6 mL dextrose or 6 mL saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves Interventions: Drug: 6 mL 2% lidocaine Procedure: Genicular nerve block
干预措施: Genicular nerve block with lidocaine (Drug)
Genicular nerve block with saline
The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves.
10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a saline was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves.
Interventions:Drug: Saline Procedure: Genicular nerve block
干预措施: Genicular nerve block with saline (Drug)
Genicular nerve block with dextrose
The ultrasound-guided genicular nerve block was performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler was used to identify the arterial structures which serve as landmarks for the corresponding nerves.
10 cm 21 G insulated block needle was inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle time is confirmed, 5 mL of a dextrose was slowly injected. Spread of local anesthetic was documented adjacent to the target nerve. This procedure was performed at the site of the three genicular nerves.
Interventions:Drug: Dextrose Procedure: Genicular nerve block
干预措施: Genicular nerve block with dextrose (Drug)
结局指标
主要结局
Efficacy of genicular nerve block on neuropathic pain reduction in knee osteoarthritis
时间窗: 3 months
Neuropathic pain reduction is measured by painDETECT questionnaire (PD-Q) which consists of 9 items that evaluate pain quality, pattern and radiation. Possible scores range from -1 to 38, with higher scores indicating more neuropathic-like symptoms. Clinical assessments:score ≤12: unlikely neuropathic pain; score 13-18: possibly neuropathic pain, and score ≥19:likely neuropathic pain.
Efficacy of genicular nerve block on nociceptive pain reduction in knee osteoarthritis.
时间窗: 3 months
Nociceptive pain reduction is measured by Visual analogue scales (VAS). The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. Pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm).
次要结局
- Efficacy of genicular nerve block on physical function in knee osteoarthritis.(6 months)
- Efficacy of genicular nerve block on walking distance in knee osteoarthritis.(6 months)
研究者
Berrak Tas
Principal Investigator
Fatih Sultan Mehmet Training and Research Hospital