Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age and Gender: Patients aged 18 to 65 years, regardless of gender.
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
Catgut embedding using PDO thread
Procedure/SurgeryParticipants 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/SurgeryParticipants 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
BehavioralBoth 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Catgut Embedding (PDO Thread) GroupExperimental treatment 2 interventions
Group B: Electro-acupuncture GroupActive comparator 2 interventions
Trial outcomes
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
Time frame
Baseline and Week 4Secondary outcomes
1
Oswestry Disability Index (ODI)
A questionnaire used to measure the patient's permanent functional impairment. The total score ranges from 0-100%, with higher scores indicating greater disability.
Time frame
Baseline and Week 4Sponsors and contacts
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Source ClinicalTrials.gov