Effectiveness and safety of acupotomy on lumbar spinal stenosis: A pragmatic randomized, controlled, pilot clinical trial
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0006234
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
1. Diagnosed with lumbar spinal stenosis by CT or MRI.
2. Have back pain or lower extremity pain for at least 3 months.
3. Aged 50–80 years
4. VAS is between 4 and 7.
5. Have no problem with language, expression, and concentration.
6. Follow-up possible during the clinical trial
7. Voluntarily signed an agreement to participate in the study.
1. Have side effect or a history of hypersensitivity to acupuncture treatment.
2. Need severe surgical treatment for neurological symptoms of cauda equine syndrome, sensory or motor paralysis.
3. Had a spinal surgery prior to the clinical trial.
4. Have been treated for Epidural nerve block within 3 months.
5. Have neuromuscular scoliosis or neurodegenerative diseases.
6. More than three times the normal category in the liver function test (SGOT, SGPT)
7. Abnormal kidney function test
8. Have a history of neurological or psychologically important medical history or currently suffers from a related condition.
9. Pregnant women, lactating women, women who have plans to conceive or do not agree with appropriate contraception options.
10. Take a anticoagulant medication.
11. Inserted the artificial pacemaker.
12. Other people regarded inappropriate by the person in charge of clinical trial.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Visual Analogue Scale(VAS)
- Secondary Outcome Measures
Name Time Method Self-rated walking distance;Short form McGill pain questionnaire;Oswestry Disability Index;Blood test and biochemistry test