Lumbar Degenerative Diseases
Conditions
Interventions
pre-assigned test group:The validated herbal fumigation formula "Ruan-Shang Wai-Xi Formula No. 1" developed by our research group (Department of Orthopaedics, Henan Luoyang Orthopaedics Hospital) was
each dose was concentrated into 500 mL of sterile solution, filled into single-use, heat-sealed pouches, and stored at 2–8 °C until use. Temperature control: A microprocessor-controlled fumigation dev
no-treatment control group:Control group: A visually and olfactorily matched placebo was prepared with identical packaging and volume. The placebo contained 1/30 of the
Sponsors
Henan Luoyang Orthopedic Hospital (Henan Provincial Orthopedic Hospital)
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) CT/MRI-confirmed lumbar degenerative disease; 2) Age 40–70 years; 3) Baseline VAS = 5; 4) Signed informed consent; 5) TCM pattern of cold-damp bi obstruction.
Exclusion criteria
Exclusion criteria: 1) Severe cardiovascular, respiratory, hematologic, metabolic, endocrine, infectious, or hepatic/renal parenchymal disease; 2) Skin lesions or allergy at fumigation site; 3) Spinal tumor, tuberculosis, or ankylosing spondylitis; 4) Pregnant, lactating, or planning pregnancy; 5) Prior related therapy within 1 month that could confound outcomes; 6) Recent lumbar spine surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity (0–100 mm VAS);Oswestry Disability Index (ODI) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lumbar ROM (flexion/extension, °);Intervertebral disc degeneration grade;Serum inflammatory markers ;Paraspinal muscle mass; | — |
Countries
China
Contacts
Public ContactSong yongwei
Henan Luoyang Orthopedic Hospital (Henan Provincial Orthopedic Hospital)
Outcome results
None listed