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临床试验/NCT03534999
NCT03534999已完成不适用

Effect of Transcutaneous Electrical Nerve Stimulation on Pain Intensity of Patients With Hip Arthroplasty: A Randomized Control Trial

Obafemi Awolowo University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年10月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
VAS. Visual Analogue Scale

研究概览

简要总结

Fifty patients with hip arthroplasty were purposively recruited for the study. They were allocated into two groups randomly with equal number. One group had TEN, other served as control. Pain intensity was measured every day of the treatment.

详细描述

Subjects that participated were post-surgical patients with hip arthroplasty receiving treatment at Orthopedic Ward of Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC), Ile-Ife. Excluded from the study were subjects who had surgery but have infected wound, those with deep vein thrombosis, and those with thrombophlebitis post-surgery. The subjects were allocated randomly into 2 groups; one group of 25 patients was on TENS (experimental group) and the other group of 25 patients was on their normal drugs without TENS (control group). Before the start of intervention, the procedure of the intervention and the way the subject would feel during the course of the intervention was explained to the subject and the consent of the patient was obtained. The procedure was as follows:The Visual Analogue Scale and Oxford hip score was administered prior to the treatment to ascertain their pain level and hip disability before the treatment. The site of intervention (5cm away from incision site) was cleaned properly with cotton wool soaked in methylated spirit in an outward motion. Before the self-adhesive, pre gelled electrodes was placed on the cleansed sites. The TENS unit was switched on and the parameters was adjusted to the required. For this study, parameters used are: 100µs pulse duration, 100Hz frequency and an intensity comfortable for the patient for a duration of 15 minutes.

At the expiration of treatment, the electrodes were removed. The treatment was carried out twice a day for three days in addition to the normal analgesic and antibiotics drugs taken by the patient. After the last treatment session, VAS and Oxford hip score was re-administered to ascertain their pain intensity and hip disability level.

For the group with no intervention The VAS and Oxford hip score was administered on the first day of contact to ascertain pain intensity and hip disability level . The subject continued on the normal analgesics only till the third day and VAS and Oxford hip score was re-administered to ascertain their pain intensity and hip disability level.

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
None

入排标准

年龄范围
40 Years 至 68 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who recently had hip arthroplasty were recruited for this study

排除标准

  • •Subjects who had surgery but have infected wounds.
  • •Patients who had deep vein thrombosis post-surgery.
  • •Patients who had thrombophlebitis post-surgery.

研究组 & 干预措施

TENS

Experimental

This is intervention Group. Patients in this group received Transcutaneous Electrical Nerve Stimulation (TENS). The VAS and Oxford hip score was administered prior to the treatment to ascertain their pain intensity and hip disability level. The site of intervention (5cm away from incision site) was cleaned properly with cotton wool soaked in methylated spirit in an outward motion. Before the self-adhesive, pre gelled electrodes was placed on the cleansed sites.The TENS unit was switched on and the parameters was adjusted to the required level. For this study, parameters used are: 100µs pulse duration, 100Hz frequency and an intensity comfortable for the patient for a duration of 15 minutes.

干预措施: Experimental. This was the group that received TENS (Device)

Control

No Intervention

This was the group with no intervention. Subjects were on their normal analgesic and antibiotic medication for the period of research. The VAS and Oxford hip score were administered on the first day to ascertain pain intensity and hip disability level. The subject continued on the normal analgesics only till the third day and VAS and Oxford hip score was re-administered to assess any change in the pain intensity and hip disability level.

TENS

Experimental

This is intervention Group. Patients in this group received Transcutaneous Electrical Nerve Stimulation (TENS). The VAS and Oxford hip score was administered prior to the treatment to ascertain their pain intensity and hip disability level. The site of intervention (5cm away from incision site) was cleaned properly with cotton wool soaked in methylated spirit in an outward motion. Before the self-adhesive, pre gelled electrodes was placed on the cleansed sites.The TENS unit was switched on and the parameters was adjusted to the required level. For this study, parameters used are: 100µs pulse duration, 100Hz frequency and an intensity comfortable for the patient for a duration of 15 minutes.

干预措施: No intervention (Other)

结局指标

主要结局

VAS. Visual Analogue Scale

时间窗: 5 days

a horizontal 100mm scale made of plastic calibrated from left (no pain) to the right (severe pain). Ratings greater 70mm indicates severe pain, 45 -74 indicates moderate pain, 5-54 indicates mild pain and 0 -5 indicates no pain

次要结局

  • Oxford hip score(5 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adesola Ojo Ojoawo

Principal Investigator

Obafemi Awolowo University

研究点 (1)

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