Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome

May 10, 2026 updated by: Thi Thuy Hang Le, University of Medicine and Pharmacy at Ho Chi Minh City

Evaluating the Efficacy of Catgut Embedding Therapy in Pain Relief and Quality of Life Improvement for Lumbar Spondylosis With Blood Stasis Syndrome

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
    • Ho Chi Minh City
      • Ho Chi Minh City, Ho Chi Minh City, Vietnam, 72400
        • Recruiting
        • University Medical Center, Ho Chi Minh City - Campus 3
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: Catgut embedding using PDO thread
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
Behavioral: Lifestyle and Exercise Counseling
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.
Active Comparator: Electro-acupuncture Group
Participants receive electro-acupuncture at the same acupoints. 20-minute sessions, 5 days per week for 4 weeks
Behavioral: Lifestyle and Exercise Counseling
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.
Procedure: Electro-acupuncture

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale (VAS) score
Time Frame: Baseline and Week 4
The VAS is used to measure the intensity of low back pain. The scale ranges from 0 to 100 mm, where 0 indicates "no pain" and 100 indicates "worst possible pain". A higher score represents more severe pain
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: Baseline and Week 4
A questionnaire used to measure the patient's permanent functional impairment. The total score ranges from 0-100%, with higher scores indicating greater disability.
Baseline and Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

May 10, 2026

First Submitted That Met QC Criteria

May 10, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8122/QD-DHYD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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