Lumbar SpondylosisNCT07590050
Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome
A study testing Catgut embedding using PDO thread, Electro-acupuncture and Lifestyle and Exercise Counseling in people with Lumbar Spondylosis and Low Back Pain, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Spondylosis, Low Back Pain
- What is being tested?
- Catgut embedding using PDO thread, Electro-acupuncture and Lifestyle and Exercise Counseling
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteVietnam
- Study dates
- 11 Mar 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University Medical Center, Ho Chi Minh City - Campus 3
Ho Chi Minh City, Ho Chi Minh City, 72400
Thi Thuy Hang Le, MD, Spec. I, +84-909789694, ltthang.ckii.yhct24@ump.edu.vn
Chung Huy Ly, MD, PhD, +84-989974868, lychunghuy@ump.edu.vn
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Lumbar Spondylosis, Low Back Pain
- Being tested
- Catgut embedding using PDO thread, Electro-acupuncture, Lifestyle and Exercise Counseling
- Keywords
- Catgut Embedding, Electro-acupuncture, Polydioxanone (PDO), Traditional Vietnamese Medicine, Blood Stasis Syndrome
- Medical subject headings
- Spondylosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catgut embedding using PDO threadProcedure or surgery
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-acupunctureProcedure or surgery
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 CounselingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Catgut embedding using PDO thread; Behavioral: 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 Receives: Procedure: Electro-acupuncture; Behavioral: Lifestyle and Exercise Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Week 4
Secondary 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.
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start11 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylosisStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thi Thuy Hang Le, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590050
- Sponsor's protocol ID
- 8122/QD-DHYD
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Catgut Embedding Therapy in Pain Relief and Quality of Life Improvement for Lumbar Spondylosis With Blood Stasis Syndrome
- ClinicalTrials.gov ID
- NCT07590050
- Acronym / sponsor ID
- 8122/QD-DHYD
- Conditions
- Lumbar Spondylosis, Low Back Pain
- Keywords
- Catgut Embedding, Electro-acupuncture, Polydioxanone (PDO), Traditional Vietnamese Medicine, Blood Stasis Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catgut Embedding (PDO Thread) Group | Experimental | Procedure: Catgut embedding using PDO thread, Behavioral: Lifestyle and Exercise CounselingParticipants 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 |
| Electro-acupuncture Group | Active comparator | Procedure: Electro-acupuncture, Behavioral: Lifestyle and Exercise CounselingParticipants receive electro-acupuncture at the same acupoints. 20-minute sessions, 5 days per week for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catgut embedding using PDO threadParticipants 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 or surgery | Catgut Embedding (PDO Thread) Group |
| Electro-acupunctureParticipants 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 | Procedure or surgery | Electro-acupuncture Group |
| Lifestyle and Exercise CounselingBoth 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. | Behavioural | Catgut Embedding (PDO Thread) Group, Electro-acupuncture Group |
Primary outcome
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
1 secondary outcome
Oswestry Disability Index (ODI)
Time frame: Baseline and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
Related trials for Lumbar Spondylosis
Recruiting
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Recruiting
The NOTICE Study: Neurosurgery and OrThopedIcs Communication Evaluation Study Following Lumbar Fusions
Lumbar Spine Degeneration, Lumbar Spine Instability
RecruitingObservational study
Thoracic-Lumbar Arthrodesis- Implanet Jazz
Spondylolisthesis, Spinal Stenosis
Not yet recruiting
Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
Lumbar Spondylosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catgut embedding using PDO thread, Electro-acupuncture and Lifestyle and Exercise Counseling in people with Lumbar Spondylosis and Low Back Pain, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thi Thuy Hang Le, MD, Spec. I (+84-909789694, ltthang.ckii.yhct24@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual Analog Scale (VAS) score (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.