Evaluation of Clinical Efficacy of Herbal Compound in the Treatment of NSLBP
- Registration Number
- NCT06336993
- Lead Sponsor
- Zhejiang Provincial Tongde Hospital
- Brief Summary
The aim of this randomized controlled trial was to explore the clinical efficacy and safety of HXTL in the treatment of NSLBP based on TCM principles and to compare the clinical outcomes of different syndromes of NSLBP with celecoxib.In this study, 80 patients with NSLBP were recruited and randomly grouped to use TCM compound and celeoxib respectively for intervention. The pain status and lumbar function use scale of patients were scored before intervention, 1 week, 2 weeks and 3 weeks after intervention, and the adverse reactions of patients after medication were recorded, and the clinical efficacy of the two groups of patients was compared finally.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- a. Patients with low back pain who were seen between January 1, 2022 and June 16, 2023 were included;
- b. meet the diagnostic criteria of NSLBP;
- c. the age range was 20-90 years old;
- d. agree to participate in the study and sign the informed consent;
- a. those who are unable to communicate normally, such as those suffering from mental and cognitive diseases, and cannot cooperate with the treatment;
- b. pregnant or lactating women;
- c. patients who are allergic to the treatment components or sulfonamides;
- d. patients with a history of coronary artery bypass grafting;
- e. patients with active gastrointestinal ulcer or bleeding;
- f. patients with severe heart failure;
- g. Patients with hepatic and renal insufficiency.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description herbal compound herbal compound - celecoxib Celecoxib -
- Primary Outcome Measures
Name Time Method Visual Analogue Scale baseline, 1 week, 2 week, 3 week after treating The visual analogue scale (VAS) is used to assess pain. It is widely used in clinical practice worldwild. The basic method is to use a walking scale about 10cm long, marked with 10 scales on one side, and the two ends are respectively "0" and "10". 0 indicates no pain, and 10 indicates the most unbearable pain. A higher score means more intense pain.
Oswestry disability index baseline, 1 week, 2 week, 3 week after treating The Oswestry Disability Index (ODI) consists of 10 questions about pain intensity, self-care, lifting, walking, sitting, standing, disturbance of sleep, sexual life, social life, and travel, with six options for each question. The maximum score for each question is 5. Select the first option to score 0 points, select the last option to score 5 points, if there are 10 questions have been answered, the scoring method is: actual score /50 (highest possible score) × 100%, if there is a question not answered, the scoring method is: Actual score /45 (highest possible score) x 100%, if higher indicates more severe dysfunction.
Japanese Orthopaedic Association Scores baseline, 1 week, 2 week, 3 week after treating Japanese Orthopaedic Association Scores are evaluated from four aspects: conscious symptoms, objective examination, limit of daily activities and bladder function. Each part is composed of several questions, with 3-4 options for each question. The highest score for each question is 2 or 3 points. The overall score ranges from 0 to 29, with lower scores indicating greater dysfunction.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Tongde Hospital
🇨🇳Hangzhou, Zhejiang, China
Tongde Hospital🇨🇳Hangzhou, Zhejiang, China