NCT07590050 Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome

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This trial targets 66 participants in total. It began in 2026-03-11 with a primary completion date of 2026-09-30.

Brief 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.

Eligibility Criteria

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.

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