Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome (NCT07590050) | Clinical Trial Compass
RecruitingNot Applicable
Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome
Vietnam66 participantsStarted 2026-03-11
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Visual Analog Scale (VAS) score
Timeframe: Baseline and Week 4
Trial details
NCT IDNCT07590050
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City