Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome

University of Medicine and Pharmacy at Ho Chi Minh City

Status: Enrolling

Conditions: Lumbar Spondylosis; Low Back Pain

Treatments: Procedure: Electro-acupuncture; Behavioral: Lifestyle and Exercise Counseling; Procedure: Catgut embedding using PDO thread

Study type: Interventional

Funder types: Other

Identifiers

NCT07590050

8122/QD-DHYD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Catgut Embedding (PDO Thread) Group

Experimental group

Description:

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

Treatment:

Procedure: Catgut embedding using PDO thread

Behavioral: Lifestyle and Exercise Counseling

Electro-acupuncture Group

Active Comparator group

Description:

Participants receive electro-acupuncture at the same acupoints. 20-minute sessions, 5 days per week for 4 weeks

Treatment:

Behavioral: Lifestyle and Exercise Counseling

Procedure: Electro-acupuncture