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临床试验/NCT06380439
NCT06380439已完成不适用

The Effect of Wrist Ankle Acupuncture on Post-Total Hip Arthroplasty Pain

Indonesia University3 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年4月23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
32
试验地点
3
主要终点
Visual Analog Scale

研究概览

简要总结

Total hip arthroplasty is one of the most cost-effective orthopedic surgical procedures which can restore hip function and improve the patient's quality of life. However, total hip arthroplasty is significantly associated with postoperative pain. Pain after total hip arthroplasty surgery can adversely affect the patient's early postoperative recovery, postoperative mobility, and hinder rehabilitation.

Wrist ankle acupuncture (WAA) is a simpler acupuncture technique, using fewer points, shallow needle insertion and lighter stimulation. Wrist-ankle acupuncture as multimodal analgesia after orthopedic surgery is useful for reducing pain and reduce the incidence of post-surgical side effects. The primary aim of this study is to investigate whether wrist ankle acupuncture therapy gives better and results for post total hip arthroplasty pain than sham wrist ankle acupuncture

详细描述

This is a clinical trial study to evaluate and compare the effects of wrist ankle acupuncture and sham wrist ankle acupuncture as a therapy for post total hip arthroplasty pain. The subjects are 32 males/female who just undergone total hip arthroplasty surgery and has returned to inpatient ward. They will be randomly assigned to 2 groups: (1) wrist ankle acupuncture and (2) Sham wrist ankle acupuncture. The subjects will receive two sessions of treatment. The outcome will be assessed before treatment (baseline), after fist acupuncture session, after second acupuncture session and a day after the second session. Patients and the outcome assessors will be blinded to the group allocation.

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

  • •Patients undergoing elective primary total hip arthroplasty surgery at dr. Cipto Mangunkusumo Hospital, Persahabatan Hospital, andFatmawati Hospital
  • •Aged over 18 years
  • •Willing to sign informed consent

排除标准

  • •Have a history of malignancy
  • •Revision total hip arthroplasty patient
  • •Post-total hip surgery patient treated in ICU.
  • •The patient has a mental disorder so he cannot understand the explanation given

研究组 & 干预措施

wrist ankle acupuncture

Experimental

wrist ankle acupuncture using 0.25 x 25mm filiform needle on lower 1, lower 4, lower 5 area ipsilateral to the surgical side, then covered with 5cm long micropore, retention for 4 hours

干预措施: wrist ankle acupuncture (Procedure)

sham wrist ankle acupuncture

Sham Comparator

0.25 x 25mm filiform needle pricked and placed on the surface of the skin on lower 1, lower 4, lower 5 area ipsilateral to the surgical side, covered with 5cm long micropore, retention for 4 hours

干预措施: wrist ankle acupuncture (Procedure)

结局指标

主要结局

Visual Analog Scale

时间窗: after the surgery when the patient has returned to the inpatient ward (before the 1st acupuncture session), 4 hours since the 1st measure (after 1st acupuncture session), one day after the 1st measure (after 2nd acupuncture), 2 days after 1st measure

Pain rating scale for measuring pain

次要结局

  • recovery rate(monitored since day 1 after surgery up to 4 days)

研究者

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

Wijayani Mardiana

medical doctore

Indonesia University

研究点 (3)

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