Acupuncture effect of Brain Functional Connectivity and Clinical Outcome of low back pain subjects using fMRI and Multi-organ a Autonomic Responses
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0002253
- Lead Sponsor
- Kyung Hee University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
1. Age: above 20 years old.
2. Subject who doesn’t have trait and psychological disorder except for low back pain
3. Subject who doesn’t have disease in cardiovascular (e.g. hypertension), opthalmological system, and who have diabetis mellitus
4. Subject who doesn’t have claustrophobia
5. Subject who didn’t have alcohol and caffein within a day, and who doesn’t have fatigues
6. Subject who doesn’t have panic disorder
7. subjects with low back or neck pain less than 3 months in duration
8. Subject who has a bothersomeness above visual analogue scale (VAS, 0: not bothersome at all, 10: extremely bothersome) 5 caused by low back or neck pain during 1 week right before the experiment
9. Subject who has no neurological problem; lumbosacral nerve function, deep tendon reflexes, plantar response, voluntary muscle activation, and sensory function
10. Subject who has nonspecific low back or neck pain especially in ICD(International Classification of Diseases)-10: M513.005.000, Lumbar DDD, M5485.001, Iliac Crest Pain Syndrome, thoracolumbar region, M5456.005, Sprain of lumbar region (non-traumatic), M5459.000.001, Low back pain, M5499.002.000 Back pain, S335, Sprain and strain of lumbar spine, S337, Sprain and strain of other and unspecified parts of lumbar spine and pelvis
S336, Sprain and strain of sacroiliac joint
11. Subject who pledges not to get other treatments until the research ends
12. Subject who voluntarily agreed to participation and signed consent form
1. subjects with low back or neck pain more than 3 months in duration
2. Subject who has a radicular pain
3. Subject who is diagnosed with serious disease can cause low back or neck pain ; metastatic cancer, vertebral fracture, spinal infection, Inflammatory spondylitis etc.
4. Subject who is suffering from other chronic diseases (cardiovascular, diabetis mellitus, persisting hepatitis, fibromyalgia, rheumatoid arthritis, dementia, clotting disorders, epilepsy etc.) disrupting interpreting clinical outcome and experimental results
5. Subject who has gotten back surgery
6. Subject who has a schedule for back surgery before the research ends
7. Subject who is suffering more severe musculoskeletal pain than low back or neck pain
8. Subjects used acupuncture treatment for low back or neck pain within 1 month
9. Subject who is not appropriate for acupuncture treatment; clotting disorders, anticoagulant therapy, cardiac pacemaker, pregnant, seizure disorders etc.
10. Subject who has difficulty to participate or be treated (paralysis, severe psychological disorder, dementia, drug addiction, no time to participate, visual or acoustical disorder, not available to get outpatient treatment, cannot read and write Korean etc.)
11. Subject who has been in litigation or compensation over low back or neck pain
12. Subject who currently takes oriental medicine for low back or neck pain treatment or unsuitable drugs (orticosteroids, narcotics, muscle relaxant, anticoagulant etc.)
13. Subject who doesn’t agree to random assignment and to sign a consent form
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method clinical pain score using vas
- Secondary Outcome Measures
Name Time Method pain score inducing experimental pain model