None listed
Conditions
Interventions
Drug, Procedure/Surgery, Behavioral : Mokhuri treatment program group 1 with herbal medication, Chuna, acupuncture and patient education, Mokhuri treatment program group 2 with Chuna, acupuncture and
Sponsors
Mok-Hurry Neck & Back Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged with 19 to 77 who have clinical symptoms and signs consistent with lumbar spinal stenosis including low back pain, radicular leg pain or leg discomfort when standing or walking will be included in the study. The patients should have claudication or radicular leg symptoms for at least one year and no symptomatic relief of pain and function related to lumbar spinal stenosis should be experienced at least three months of enough conservative non-surgical treatments including epidural injection therapy, administration of analgesics and (or) physiotherapies. He or she needs to be diagnosed as lumbar spinal stenosis through CT or MRI findings and has been recommended of decompression and (or additionally) fusion surgery by neurosurgeons or orthopedic doctors within one year. Neurogenic claudication should appear within five minutes when walking on a treadmill with 1.5 mile/hour of speed. Finally, the patient should have not been treated with epidural injection during last 1 month.
Exclusion criteria
Exclusion criteria: 1. Patients who show at least one of the following conditions will be excluded from this study: -Past or present existence of a movement disorder and orthopedic problems that might affect the ability to ambulate -Moderate to severe arthritis of the knee or hip that might severely compromise ambulation -Past or present lower extremity peripheral vascular disease or vascular claudication -Previous lumbar spinal stenosis surgery -Serious concomitant medical illness (i.e. heart disease, renal failure and active hepatitis) -Another specific spinal disorder (e.g. ankylosing spondylitis, infection, metabolic diseases or severe osteoporosis) -Presence of major or progressive neurological deficit including dementia -Severe systemic diseases including coronary artery disease or malignancy -Past or present any psychiatric conditions including depression etc. -Present usage of narcotic analgesics including transdermal patch -Present digestive disorders including gastritis, gastric ulcer, irritable bowel syndrome etc. 2. Anyone who is pregnant currently or has a plan to be pregnant 3. Anyone who is expected to be inappropriate for the participation of this study due to the issues of noncompliance related to the treatments, visit and answering questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric rating scale for low back pain | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeric rating scale for leg pain;Korean version of EQ-5D;Oswestry Disability Index ;Roland-Morris Disability Questionnaire ;Oxford Claudication Score ;Walking duration and distance free of leg pain;Treadmill test;MRI & L-spine x-ray;Follow up evaluation on the experience of additional treatment after the end of participation;Adverse events;Blood test for safety assessment;Feasibility (recruitement rate, dropout rate, compliance rate, qualitative analysis on the outcome assessors' experience and sample size calcuation) | — |
Countries
Korea, Republic of
Contacts
Public ContactHan-Sol Park
Mok-Hurry Neck & Back Hospital
Outcome results
None listed