Percutaneous Peripheral Temporary Neurostimulation in Moderate to Severe Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in visual analogue scale after intervention.
研究概览
简要总结
Peripheral nerve stimulation (PNS) is a drug-free pain management procedure that uses electrical impulses to target specific nerves and block pain signals. PNS helps decrease perception of pain, providing real answers to patients dealing with chronic knee pain. The case study discussed in this presentation is of the use of PNS targeting the superior lateral genicular nerve and the saphenous nerve for a patient with moderate to severe knee pain from osteoarthritis
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This is a prospective, double-blinded, randomised study. The closed envelop randomization method will be used for the randomization of the patients who will be also blinded to group allocation.
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
- •adults between the ages of 30 and 70 years with a clinical diagnosis of moderate to severe knee OA who suffered knee pain.
- •Patients who cannot afford intra-articular injections or radiofrequency ablation (RFA).
- •patients who had failed 2 different oral pain medications and 6 weeks of physical therapy.
排除标准
- •Patients with OA show improvement in pain after physiotherapy.
- •patients evaluated by an orthopaedic surgeon and deemed to be surgical candidates due to knee pathologies other than OA.
- •pregnant patients.
- •patients on anticoagulation therapy, who were not permitted to stop anticoagulation.
- •patients with previous trauma, neurological or endocrine diseases like diabetes mellitus, and knee tumors; and patients with inflammatory arthritis.
- •people who had received an intra-articular knee injection within the last 6 months.
- •Patients with tendon tears, bursitis, or calcified tendonitis as proven by imaging.
研究组 & 干预措施
transcutaneous nerve stimulation using a nerve stimulator to the genicular nerve block
干预措施: nerve stimulation using a nerve stimulator to the genicular nerve (Device)
transcutaneous nerve stimulation using a nerve stimulator to the saphenous nerve
干预措施: nerve stimulation using a nerve stimulator to the saphenous nerve (Device)
结局指标
主要结局
Change in visual analogue scale after intervention.
时间窗: immediately after intervention.
Decrement (clinical improvement) in visual analogue scale (VAS) immediately after intervention. The participant's knee discomfort was measured using a VAS. Participants were asked to score their level of pain on a 100-mm horizontal line, ranging from 0 to 100.
次要结局
未报告次要终点
研究者
Aliaa Mamdouh Abdelaziz Farag
Lecturer
Tanta University