NCT07590050

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Mar 2026Oct 2026

Study Start

First participant enrolled

March 11, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 10, 2026

Last Update Submit

May 10, 2026

Conditions

Lumbar SpondylosisLow Back Pain

Keywords

Catgut EmbeddingElectro-acupuncturePolydioxanone (PDO)Traditional Vietnamese MedicineBlood Stasis Syndrome

Outcome Measures

Primary Outcomes (1)

  • Change in Visual Analog Scale (VAS) score

    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 Outcomes (1)

  • Oswestry Disability Index (ODI)

    Baseline and Week 4

Study Arms (2)

Catgut Embedding (PDO Thread) Group

EXPERIMENTAL

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 threadBehavioral: Lifestyle and Exercise Counseling

Electro-acupuncture Group

ACTIVE COMPARATOR

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

Procedure: Electro-acupunctureBehavioral: Lifestyle and Exercise Counseling

Interventions

Catgut embedding using PDO threadPROCEDURE

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

Catgut Embedding (PDO Thread) Group
Electro-acupuncturePROCEDURE

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

Electro-acupuncture Group
Lifestyle and Exercise CounselingBEHAVIORAL

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.

Catgut Embedding (PDO Thread) GroupElectro-acupuncture Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center, Ho Chi Minh City - Campus 3

Ho Chi Minh City, Ho Chi Minh City, 72400, Vietnam

RECRUITING

MeSH Terms

Conditions

SpondylosisLow Back Pain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Thi Thuy Hang Le, MD, Spec. I

CONTACT

+84-909789694ltthang.ckii.yhct24@ump.edu.vn

Chung Huy Ly, MD, PhD

CONTACT

+84-989974868lychunghuy@ump.edu.vn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 10, 2026

First Posted

May 15, 2026

Study Start

March 11, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations

VN(1)