Is Interferential Current Effective in the Management of Pain, Range of Motion, Edema Following Total Knee Arthroplasty Surgery?: Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Change in Pain from baseline measured by visual analog scale
研究概览
简要总结
Interferential current is widely used as a popular treatment in painful musculoskeletal disorders. And total knee arthroplasty patients present with extreme pain immediately after surgery. So this study is aimed to investigate the effectiveness of interferential current implementation following total knee arthroplasty surgery. In this study interferential current compared with sham interferential current . Patients were assessed with pain, range of motion , edema and the amount of used paracetamol.
详细描述
A total of 132 patients ranging in 60-85 years who were undergoing their first total knee arthroplasty due to knee OA were recruited into a randomized, double-blind, prospective and controlled study. Participants were recruited at the Orthopedics and Traumatology inpatient clinic. The patients were seen postoperative first day and were assigned to receive either interferential current or sham interferential current by block randomization. After the procedure was explained to each subject, interferential current treatment was applied 2 times for 5 days, each treatment was continued approximately 30 minutes. Four electrodes were used to deliver quadripolar interferential current Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a "strong but comfortable level" at all times. The sham interferential current treatment consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes. At the same time, all patients received standard postoperatively rehabilitation program. Patients were assessed with pain, range of motion , edema and the amount of used paracetamol.
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, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent total knee arthroplasty surgery
排除标准
- •Patients who had experienced of any electrotherapy prior to the TKA to be sure blinding of therapy
- •Patients who had history of any contraindication for electrotherapy
- •Patients who had chronic pain rather than knee OA
- •Patients who had experienced a known or suspected joint infection or a specific condition (ie, peripheral or central nervous system lesions, neoplasm, diabetes mellitus, osteonecrosis, recent trauma and pacemaker)
- •Patients who had history of stroke, central nervous disease, mental impairment or poor general health status that would interfere with functional assessments during the study
研究组 & 干预措施
Interferential Current Treatment
Interferential Current group received interferential current treatment 30 minutes, 2 times a day for 5 days after the surgery.
干预措施: Interferential Current (Device)
Sham Interferential Current Treatment
In the sham interferential Current treatment, no electrical stimulation was applied to the probes with the same pads for the same time.
干预措施: Sham Interferential Current (Device)
结局指标
主要结局
Change in Pain from baseline measured by visual analog scale
时间窗: Change in pain measured 5th and 30th days after surgery
Pain intensity that was measured by visual analog scale (minimum score:0; maximum score:100)(higher values represent worse outcome)
次要结局
- Change of Edema from baseline(Change of Edema measured 5th and 30th days after surgery)
- Amount of used paracetamol(5th and 30th days after surgery)
- Change of Range of Motion from baseline(Change of Range of Motion measured 5th and 30th days after surgery)
研究者
Mehmet Resul KADI
Principal Investigator
Ege University