Chronic non-specific low back pain
Conditions
Interventions
Experimental group:test device + rehabilitation training
Control group:placebo treatment + rehabilitation training
Sponsors
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
Eligibility
Sex/Gender
All
Age
20 Years to 74 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria (1) Age >=18 years old, gender is not limited; (2) Chronic non-specific low back pain, in line with the ‘China Expert Consensus on the Diagnosis and Treatment of Acute/Chronic Non-Specific Low Back Pain’ diagnostic criteria, the duration of the disease >=12 weeks, and the VAS score >=4; (3) Voluntary participation in the trial and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of infection, rash, broken skin at the site of irradiation; 2. epilepsy; 3. haemorrhagic or haemolytic diseases; 4. severe functional insufficiency of single or multiple organs; 5. hepatic or renal dysfunction (blood creatinine greater than the upper limit of normal; or alanine aminotransferase/glutamine aminotransferase greater than 1.5 times the upper limit of normal); 6. Previous surgical treatment for lumbar and thoracic spine; 7. The presence of: spinal stenosis, nerve root compression, spinal fracture at the site to be treated; 8. Porphyria, the trial period to adhere to the following: quinolones, tetracyclines, sulfonamides, grey flavonoids, hydrochlorothiazide, amiodarone, sulfonylurea hypoglycemic drugs, antidepressants and antipsychotics and other drugs that seriously affect photosensitivity; 9. serious cardiac arrhythmias such as atrioventricular block, sinus node disease, atrial fibrillation, ventricular fibrillation, etc; 10. wearing pacemakers or having metallic implants in the body; 11. patients with malignant aggressive tumours; 12. Mental incapacity or inability to understand the requirements for participation in the trial; 13. pregnancy, breastfeeding or intention to become pregnant in the last 1 month 14. Alcoholism (drinking 5 or more bottles of beer (500ml) or 3 or more taels of white wine per day for more than 2/3 of the time for 2 consecutive months); 15. Participation in other medical device or drug clinical trials within 1 month prior to screening; 16. other conditions that the investigator considers unsuitable for enrolment, such as expected poor adherence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale, VAS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Japanese Orthopaedic Association score, JOA;Patient satisfaction with product usage; | — |
Countries
China
Contacts
Public ContactXiaobin Tang
Hebei PetroChina Central Hospital
Outcome results
None listed