Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome

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.

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.