Evaluating the Efficacy of Catgut Embedding Therapy in Pain Relief and Quality of Life Improvement for Lumbar Spondylosis With Blood Stasis Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Visual Analog Scale (VAS) score
研究概览
简要总结
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.
详细描述
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.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Catgut embedding using PDO thread (Procedure)
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
干预措施: Lifestyle and Exercise Counseling (Behavioral)
Electro-acupuncture Group
Participants receive electro-acupuncture at the same acupoints. 20-minute sessions, 5 days per week for 4 weeks
干预措施: Electro-acupuncture (Procedure)
Electro-acupuncture Group
Participants receive electro-acupuncture at the same acupoints. 20-minute sessions, 5 days per week for 4 weeks
干预措施: Lifestyle and Exercise Counseling (Behavioral)
结局指标
主要结局
Change in Visual Analog Scale (VAS) score
时间窗: 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
次要结局
- Oswestry Disability Index (ODI)(Baseline and Week 4)
研究者
Thi Thuy Hang Le
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City