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临床试验/NCT06868173
NCT06868173已完成不适用

Evaluation of the Analgesic Efficacy of Trigger Point Electroacupuncture in Patients With Chronic Low Back Pain: a Blinded Randomised Controlled Trial

University of Medicine and Pharmacy at Ho Chi Minh City2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月15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
发起方
入组人数
60
试验地点
2
主要终点
Comparison of VAS pain intensity between electroacupuncture at the trigger point and electroacupuncture traditional point group

研究概览

简要总结

Electroacupuncture is an application of acupuncture combined with electrical stimulation of acupuncture points through acupuncture needles to achieve faster pain relief than acupuncture. Recently, research has shown that Trigger point acupuncture has a significant effect in reducing pain better than acupuncture on acupoints in patients with chronic low back pain. However, no research has compared the pain relief effect between Trigger Point electroacupuncture and electroacupuncture on acupoints in patients with chronic low back pain. This study was conducted to address this question.

详细描述

Participants and Methods: A blinded randomized controlled clinical trial was conducted involving 60 chronic low back pain participants, randomly divided into two groups (A and B): 30 receiving electroacupuncture at the Trigger point (group A) and 30 receiving electroacupuncture on the meridian (group B) for 10 sessions. The primary outcomes were visual analogue scale (VAS), BPI index, and Trigger point count.

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)

盲法说明

The study participants will not know which electroacupuncture group they are in.

The acupuncturist and the data processor are 2 different people.

入排标准

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

入选标准

  • •Patients aged 20 or older who consented to participate in the study;
  • •Individuals experiencing LBP persisting for more than 3 months with an average VAS score of 5 cm or over;
  • •Patients displaying trigger points in back

排除标准

  • •Major trauma or systemic disease such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Scheuermann disease;
  • •Systemic symptoms such as weight loss, fever of unknown origin, anorexia, personal history of malignancy, diffuse pain and joint stiffness;
  • •Symptoms of infection such as fever, meningeal irritation signs, photophobia;
  • •Symptoms of central motor neuron damage such as Hoffmann sign, Babinski sign, hyperreflexia, spasticity, incontinence, sexual dysfunction;
  • •Symptoms of serious acute diseases such as myocardial infarction (chest pain, sweating, shortness of breath), arterial dissections (tearing sensation, headache, blurred vision);
  • •Conditions unsuitable for acupuncture such as inflammation of skin in need of acupuncture, weak or exhausted patients, severe comorbidities;
  • •Being treated with other methods. Elimination criteria: Patients experiencing adverse events from the intervention leading to their discomfort and withdrawal from the study

研究组 & 干预措施

Electro-acupuncture at traditional points

Sham Comparator

30 patients with non-radiating low back pain for at least three months and normal neurological examination received treatment electro-cupuncture at traditional points for 10 sessions over 4 weeks, electroacupuncture was administered once per session, three sessions per week, on alternate days, with rest on Saturdays and Sundays. Visual analogue scale (VAS) will be recorded after 1 session, 3 session, 5 session, 7 session and 10 session. BPI index and Trigger point count will be recorded after 1 session, 5 session, 10 session.

干预措施: Electro-acupuncture (Device)

Electro-acupuncture at the Trigger point

Active Comparator

30 patients with non-radiating low back pain for at least three months and normal neurological examination received treatment electro-acupuncture at the Trigger point for 10 sessions over 4 weeks, electroacupuncture was administered once per session, three sessions per week, on alternate days, with rest on Saturdays and Sundays. Visual analogue scale (VAS) will be recorded after 1 session, 3 session, 5 session, 7 session and 10 session. BPI index and Trigger point count will be recorded after 1 session, 5 session, 10 session.

干预措施: Electro-acupuncture (Device)

结局指标

主要结局

Comparison of VAS pain intensity between electroacupuncture at the trigger point and electroacupuncture traditional point group

时间窗: Baseline, after 3 sessions, after 5 sessions, after 7 sessions, after 10 sessions

With the VAS, participants were asked to make a hatch mark on a 100 mm line that represents their average pain intensity. These were then converted to a numerical score for each face (i.e. 0, 2, 4, 6, 8, or 10), depending on the face selected. The end-point descriptors for VAS was "No pain" (0, 0 mm, and the face representing no pain, respectively) and "The most intense pain imaginable" (10, 100 mm, and the face representing the most intense pain level, respectively).

次要结局

  • Comparison of BPI index between electroacupuncture at the trigger point and electroacupuncture traditional point group.(Baseline, after 5 sessions, and after 10 sessions)

研究者

发起方
University of Medicine and Pharmacy at Ho Chi Minh City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bui Pham Minh Man

Doctor of Philosophy

University of Medicine and Pharmacy at Ho Chi Minh City

研究点 (2)

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