Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome

Sponsor
University of Medicine and Pharmacy at Ho Chi Minh City
Study ID
NCT07590050
Status
Recruiting
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Conditions

  • Low Back Pain
  • Lumbar Spondylosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Catgut embedding using PDO thread — PROCEDURE
    Participants receive catgut embedding therapy using polydioxanone (PDO) threads, size 29G x 30 mm. The procedure involves inserting the thread into acupoints including BL23, BL24, BL25, BL26, BL17, and SP10. The treatment is performed twice: at baseline (Week 0) and at Week 2
  • Electro-acupuncture — PROCEDURE
    Participants receive acupuncture at 6 pairs of acupoints: BL23, BL24, BL25, BL26, BL17, and SP10. Electro-acupuncture: Applied to the 4 lumbar points (BL23, BL24, BL25, BL26) using the KWD-808-I device for 20 minutes. Manual Acupuncture: Applied to the remaining points (BL17 and SP10). Frequency: Once daily, 5 days per week, for 4 weeks
  • Lifestyle and Exercise Counseling — BEHAVIORAL
    Both groups receive standardized guidance on daily lifestyle modifications and lumbar exercises. This includes instructions on correct sitting and standing postures, lifting techniques, and a specific set of stretching and strengthening exercises for the lower back to be performed at home.

Study Details

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.

Key Dates

First listed
May 15, 2026
Start date
Mar 11, 2026
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Active Comparator: Electro-acupuncture Group
    Participants receive electro-acupuncture at the same acupoints. 20-minute sessions, 5 days per week for 4 weeks

Primary Outcome Measure

Change in Visual Analog Scale (VAS) score [ Time Frame: Baseline and Week 4 ]

Central Contacts

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