Catgut Embedding for Lumbar Spondylosis With Blood Stasis Syndrome
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Thi Thuy Hang Le, MD, Spec. I
- Numéro de téléphone: +84-909789694
- E-mail: ltthang.ckii.yhct24@ump.edu.vn
Sauvegarde des contacts de l'étude
- Nom: Chung Huy Ly, MD, PhD
- Numéro de téléphone: +84-989974868
- E-mail: lychunghuy@ump.edu.vn
Lieux d'étude
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Ho Chi Minh City
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Ho Chi Minh City, Ho Chi Minh City, Viêt Nam, 72400
- Recrutement
- University Medical Center, Ho Chi Minh City - Campus 3
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Contact:
- Thi Thuy Hang Le, MD, Spec. I
- Numéro de téléphone: +84-909789694
- E-mail: ltthang.ckii.yhct24@ump.edu.vn
-
Contact:
- Chung Huy Ly, MD, PhD
- Numéro de téléphone: +84-989974868
- E-mail: lychunghuy@ump.edu.vn
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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
|
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
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.
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Comparateur actif: Electro-acupuncture Group
Participants receive electro-acupuncture at the same acupoints.
20-minute sessions, 5 days per week for 4 weeks
|
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.
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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Visual Analog Scale (VAS) score
Délai: Baseline and Week 4
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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
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Baseline and Week 4
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oswestry Disability Index (ODI)
Délai: 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.
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Baseline and Week 4
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 8122/QD-DHYD
Informations sur les médicaments et les dispositifs, documents d'étude
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