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Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome

2026年5月10日 更新者：Thi Thuy Hang Le、University of Medicine and Pharmacy at Ho Chi Minh City

Evaluating the Efficacy of Catgut Embedding Therapy in Pain Relief and Quality of Life Improvement for Lumbar Spondylosis With Blood Stasis Syndrome

The goal of this clinical trial is to learn if catgut embedding works to treat chronic low back pain in adults with lumbar spondylosis and "Blood Stasis" syndrome. The main questions it aims to answer are:

Does catgut embedding lower back pain more effectively than electro-acupuncture?

Does catgut embedding improve the daily physical activities of participants?

Researchers will compare catgut embedding to electro-acupuncture to see which method works better to reduce pain and improve quality of life. All participants will also receive counseling on lifestyle changes and back exercises.

Participants will:

Be randomly assigned to receive either catgut embedding (2 sessions over 4 weeks) or electro-acupuncture (20 sessions over 4 weeks).

Visit the clinic for treatments and checkups.

Complete surveys about their pain levels and ability to perform daily tasks at the start, at 2 weeks, and at 4 weeks.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Study Population: 66 patients diagnosed with lumbar spondylosis (Blood Stasis syndrome) will be randomly assigned to one of two groups.

Group 1 (Control): Electro-acupuncture + Lifestyle and exercise counseling.

Acupoints: BL23 (Shenshu), BL24 (Qihaishu), BL25 (Dachangshu), BL26 (Guanyuanshu), BL17 (Geshu), and SP10 (Xuehai).

Procedure: 20-minute sessions, once daily, 5 days per week for 4 weeks.

Group 2 (Intervention): Catgut Embedding + Lifestyle and exercise counseling.

Acupoints: Same as the control group.

Procedure: 2 sessions. The first session at week 0 (T0) and the second session at week 2 (T2) using PDO thread (29G x 30 mm).

Evaluation:

Assessment time points: T0 (baseline), T2 (2 weeks), and T4 (4 weeks).

Primary outcomes: Visual Analog Scale (VAS) for pain and Oswestry Disability Index (ODI) for functional recovery.

Safety: Monitoring for any adverse effects during the 4-week period.

Staff: Procedures are performed by qualified Traditional Medicine doctors in compliance with the regulations of the Ministry of Health.

研究类型

介入性

注册 (估计的)

66

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 越南
    • Ho Chi Minh City
      • Ho Chi Minh City、Ho Chi Minh City、越南、72400
        • 招聘中
        • University Medical Center, Ho Chi Minh City - Campus 3
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age and Gender: Patients aged 18 to 65 years, regardless of gender.

  • Diagnosis of Chronic Low Back Pain: Confirmed diagnosis of low back pain due to lumbar spondylosis with the following criteria:

    • Clinical: Mechanical spinal pain.
    • Radiographic (X-ray): Joint space narrowing, subchondral sclerosis, and osteophytes on the vertebral bodies.
    • Absence of systemic symptoms such as fever, unexplained weight loss, or anemia.
  • Duration: Pain duration exceeding 3 months.
  • Pain Intensity: Visual Analog Scale (VAS) score for low back pain > 40 mm.
  • Traditional Medicine Diagnosis: Diagnosed with Low back pain under the "Blood Stasis" syndrome according to Decision No. 5013/QD-BYT (2020) by the Ministry of Health: Pain occurs after heavy lifting or sudden movement. Severe localized pain, pain increases with movement/pressure. Limited range of motion. Tongue: Purple or with stasis points. Pulse: Choppy.
  • Communication: Capable of communicating fluently in Vietnamese to complete survey questionnaires.
  • Consent: Volunteers who agree to participate and sign the Informed Consent Form.

Exclusion Criteria:

  • Neurological Deficits: Patients with clinical neurological abnormalities in the lower limbs.
  • Surgical Indications: Patients with indications for spinal surgery due to severe neurological deficits.
  • Co-morbidities: Vertebral fractures, spinal inflammation/infection, malignant tumors, neuromuscular scoliosis, or degenerative neurological diseases.
  • Hypersensitivity: History of hypersensitivity or adverse reactions to electro-acupuncture or catgut embedding treatments.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Catgut Embedding (PDO Thread) Group
Participants receive catgut embedding using PDO threads at acupoints (BL23, BL24, BL25, BL26, BL17, SP10) using PDO threads. 2 sessions total: week 0 and week 2
程序：Catgut embedding using PDO thread
Participants receive catgut embedding therapy using polydioxanone (PDO) threads, size 29G x 30 mm. The procedure involves inserting the thread into acupoints including BL23, BL24, BL25, BL26, BL17, and SP10. The treatment is performed twice: at baseline (Week 0) and at Week 2
行为的：Lifestyle and Exercise Counseling
Both groups receive standardized guidance on daily lifestyle modifications and lumbar exercises. This includes instructions on correct sitting and standing postures, lifting techniques, and a specific set of stretching and strengthening exercises for the lower back to be performed at home.
有源比较器：Electro-acupuncture Group
Participants receive electro-acupuncture at the same acupoints. 20-minute sessions, 5 days per week for 4 weeks
行为的：Lifestyle and Exercise Counseling
Both groups receive standardized guidance on daily lifestyle modifications and lumbar exercises. This includes instructions on correct sitting and standing postures, lifting techniques, and a specific set of stretching and strengthening exercises for the lower back to be performed at home.
程序：Electro-acupuncture

Participants receive acupuncture at 6 pairs of acupoints: BL23, BL24, BL25, BL26, BL17, and SP10.

Electro-acupuncture: Applied to the 4 lumbar points (BL23, BL24, BL25, BL26) using the KWD-808-I device for 20 minutes.

Manual Acupuncture: Applied to the remaining points (BL17 and SP10).

Frequency: Once daily, 5 days per week, for 4 weeks

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Visual Analog Scale (VAS) score
大体时间：Baseline and Week 4
The VAS is used to measure the intensity of low back pain. The scale ranges from 0 to 100 mm, where 0 indicates "no pain" and 100 indicates "worst possible pain". A higher score represents more severe pain
Baseline and Week 4

次要结果测量

结果测量
措施说明
大体时间
Oswestry Disability Index (ODI)
大体时间：Baseline and Week 4
A questionnaire used to measure the patient's permanent functional impairment. The total score ranges from 0-100%, with higher scores indicating greater disability.
Baseline and Week 4

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Medicine and Pharmacy at Ho Chi Minh City

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月11日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年10月30日

研究注册日期

首次提交

2026年5月10日

首先提交符合 QC 标准的

2026年5月10日

首次发布 (实际的)

2026年5月15日

研究记录更新

最后更新发布 (实际的)

2026年5月15日

上次提交的符合 QC 标准的更新

2026年5月10日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 8122/QD-DHYD

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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