Chronic non-specific low back pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 70 years old (including 18 and 70 years old). (2) Patients who meet the Western and Traditional Chinese Medicine diagnosis of chronic non-specific low back pain. (3) According to the researchers' judgment, blood sugar has been steadily controlled. (4) Visual Analog Scale Score (VAS) = 30mm and<70mm during screening visits; (5) Non smokers (who have quit smoking for at least 6 months before screening) or occasional smokers (who have smoked = 30 cigarettes within six months); (6) The patient agrees to participate in this study and signs an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients diagnosed clinically with acute low back pain or a history of lumbar specific diseases. (2) I have taken drugs containing analgesic ingredients such as ibuprofen and lofenamine three days before screening. (3) People who are allergic to the components of thunder and fire acupuncture and moxibustion or who are intolerant of high temperature. (4) Poor blood sugar control (immediate blood sugar = 11). (5) Subjects with lower limb pain due to other reasons, such as insufficient blood supply (peripheral arterial disease), lumbar disc herniation or vasculitis, or other severe pain that may be confused for evaluation. (6) 12-lead ECG with clinically significant abnormalities, and determined by the researchers as unsuitable for enrollment. (7) Subjects who had received non drug treatment for diabetes peripheral neuropathic pain within 2 weeks before screening or were receiving non drug treatment. (8) A history of severe cardiovascular disease, hematopoietic system disease, etc. (such as congestive heart failure, poorly controlled coronary heart disease, stroke, clinically significant arrhythmia, known aortic aneurysm, poorly controlled hypertension (with systolic blood pressure = 160mmHg or diastolic blood pressure = 100mmHg detected twice or more in a row). (9) Subjects whose body parts (except toes) were amputated due to complications of diabetes. (10) The presence of major diseases (including patients with advanced cancer combined with cancer pain) and unstable diseases or mental disorders may affect the participants in the study, as assessed by the researchers. (11) Subjects with a history of drug abuse or alcohol abuse within the first 6 months of screening are defined as those who regularly drink more than 14 times per week (1 time ˜ 150mL of wine, 360mL of beer, or 45mL of spirits). (12) Select subjects who have participated in any clinical trial within the previous month. (13) Pregnant or lactating women or subjects (including males) who have a fertility plan within 6 months. (14) Subjects who have been determined by the researcher to have other circumstances that are not suitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale;The Oswestry Disabilitiy Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| visual analogue scale;The Oswestry Disabilitiy Index; | — |
Countries
China
Contacts
Dongzhimen Hospital of Beijing University of Chinese Medicine