Efficacy Study of Acupuncture to Treat Spinal Pain

Study Overview
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Brief Summary
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This study is being conducted to investigate the effectiveness and safety of acupuncture for alleviating pain of spondylosis.

Detailed Description
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This study is being conducted at the Daegu Catholic University Medical Center. Enrolled participants will be randomized into two groups : acupuncture treatment plus epidural block and epidural block alone. This trial will include treatments during 3 weeks, and then follow up after 2 weeks. Participants will have acupuncture treatments of three times per week and epidural block of once per week. All examinations and treatments will be provided free of charge. Compared with epidural block group, acupuncture plus epidural block group will give more effectiveness for alleviate pain caused by lumbar spondylosis.

Official Title
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Pilot Study of Efficacy and Safety of Acupuncture on Patient With Spinal Pain Due to Spondylolithesis

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Acupuncture
* Procedure: Epidural nerve block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 65 years Meyerding Grade I-II spondylolisthesis Low back pain of at least 1-year duration Follow-up possible during the clinical trial Written informed consent voluntarily Exclusion Criteria: Cauda equina syndrome, persistently exacerbated symptoms, progressive neurologic signs (sensory or motor changes) Previous spine surgery Senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders Severe, concomitant disease (neuromuscular scoliosis, neurodegenerative disease) All contraindications to corticosteroid injection (e.g., insulin-dependent diabetes) Alcohol/drug abuse Significant renal or hepatic disease Pregnant, lactating or planning a pregnancy Hypersensitive reaction to acupuncture treatment Inability to comprehend or express oneself in the Korean language An individual deemed to be ineligible by a physician Refusal to participate in the trial or to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture & Epidural nerve block<br>acupuncture plus epidural block | Device: Acupuncture<br>* BL40, BL60, ST36, GB34 : bilaterally, manual acupuncture. Two points on 1st bladder meridian nearest location of back pain : bilaterally, electrical acupuncture.<br>Procedure: Epidural nerve block<br>* Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).<br>|
| Active Comparator: Epidural nerve block<br>epidural block alone | Procedure: Epidural nerve block<br>* Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale(VAS) | This outcome will measure changes in the participant's level of low back pain. | Change from baseline to 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short form McGill pain questionnaire |  | Chagnes from baseline to 5 weeks | 
| Oswestry Disability Index |  | Changes from baseline to 5 weeks | 
| Present pain intensity(PPI) |  | Changes from baseline to 5 weeks | 
| Pain vision | A device Pain vision Ⓡ PS-2100 calculates a degree of pain in cancer patients in addition to VAS | Chagnes from baseline to 5 weeks |