Low Back Pain
Conditions
Brief summary
This study is being conducted to investigate the effectiveness and safety of acupuncture for alleviating pain of spondylosis.
Detailed description
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.
Interventions
DEVICEAcupuncture
* BL40, BL60, ST36, GB34 : bilaterally, manual acupuncture. * Two points on 1st bladder meridian nearest location of back pain : bilaterally, electrical acupuncture.
PROCEDUREEpidural nerve block
Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).
Sponsors
Daegu Catholic University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale(VAS) | Change from baseline to 5 weeks | This outcome will measure changes in the participant's level of low back pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Chagnes from baseline to 5 weeks | A device Pain vision Ⓡ PS-2100 calculates a degree of pain in cancer patients in addition to VAS |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety | After the initiation of acupuncture, 2 weeks, and 4 weeks | We will confirm the safety of acupuncture by determining the red blood cell (RBC) count, hemoglobin level, platelet count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), hematocrit (Hct), total white blood cell (WBC) count, Erythrocyte Sedimentation Rate (ESR), aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum urea nitrogen (BUN), creatinine level, serum sodium level, serum potassium level, and serum chloride level. All patients were evaluated 3 times, including a final follow-up visit 4 weeks after the initiation of acupuncture. |
Countries
South Korea
Contacts
Primary ContactUn-Suk Noh, M.D,Ph.D
Outcome results
None listed