Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome

Official title

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

Overview

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.

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.

Interventions

• 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
• 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
• 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.

Primary outcome measures

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

Secondary outcome measures (1)

• Oswestry Disability Index (ODI) [Time frame: Baseline and Week 4]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Vietnam · 1 center

• University Medical Center, Ho Chi Minh City - Campus 3 — Ho Chi Minh City

Identifiers

NCT: NCT07590050 · 8122/QD-DHYD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗