Lumbar disc herniation Musculoskeletal Diseases
Conditions
Interventions
Patients who meet the inclusion and exclusion criteria will be randomly divided into the treatment group and control group, with 97 patients in each group. The random sequence is generated using R, a
Sponsors
Gansu Cheezheng Tibetan Medicine Co., Ltd. (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants who meet the diagnostic criteria based on the Chinese Pain Expert Consensus on the Diagnosis and Treatment of Lumbar Disc Herniation published by the Spine-derived Pain Section, Pain Branch, Chinese Medical Association, in 2020 2. Participants with pain and/or numbness and muscle tension in the lower back and lower limbs 3. Participants with visual analogue scale (VAS, 0-10 points) scored =4 points 4. Participants aged between 18 to 65 years old 5. Participants who are volunteer to participate in the study and sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Participants with spondylolisthesis or herniated nucleus pulposus severely compressing the cauda equina, or with obvious surgical indications and not suitable for conservative treatment 2. Participants suffering from other diseases with lower back pain symptoms, such as ankylosing spondylitis, etc. 3. Participants who are allergic to the study drugs (Baimai ointment) 3. Participants suffering from severe cardiovascular, cerebrovascular, liver, and kidney diseases 4. Participants suffering from mental diseases or senile dementia who cannot cooperate with the clinical research 5. Women during pregnancy or lactation 6. Participants with skin ulceration at the affected joint(s) 7. Participants with skin ulceration on the lower back 8. Participants who participate in other clinical trials at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Lumbar spinal joint dysfunction measured using a Japanese orthopaedic association scores (JOA, 0-29 points) at baseline, after 1st week of treatment, after 2nd week of treatment, and at 1 week of follow-up after the end of treatment. 2. Lower back and leg pain measured using a visual analogue scale (VAS, 0-10 points) at baseline, every day during treatment, and after 1 week of follow-up after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lower back and leg numbness measured using a 4-point Likert scale (0-3 points) at baseline, every day during treatment, and after 1 week of follow-up after the end of treatment. 2. The proportion of the two groups receiving rescue therapy and their respective treatment methods, such as the name, frequency, usage and dosage of the medicines used. 3. Compliance with health education every day during treatment and during follow-up for 1 week after the end of treatment. The items of health education include wearing waist circumference, bed rest and other measures (protection from cold and warmth, avoiding excessive fatigue, avoiding excessive torsion or flexion, and excessive weight bearing of the lower back). | — |
Countries
China
Outcome results
None listed