Combination Therapy With Atelocollagen in Epidural Nerve Block
Study Details
Study Description
Brief Summary
"In this study, the investigators plan to evaluate muscle mass and pain relief 4 weeks after performing epidural nerve block and Type I porcine atelocollagen injection into multifidus muscle in patients with chronic low back pain due to degenerative spinal disease for more than 6 months.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Atelocollagen group After obtaining informed consent for the study, epidural nerve block was performed. The patient is asked to return to the outpatient clinic of the pain center after 2 weeks. At this time, when the NRS of back pain does not improve by more than 50% compared to before the epidural nerve block and the cross-sectional area of the multifidus muscle using ultrasound is 5 cm2 or less, final enrollment is decided. The evaluation of the cross-sectional area and thickness of the multifidus muscle using ultrasound is performed with the patient prone, and the cross-sectional area of the multifidus muscle is measured at the same position as the level of the lesion on MRI. |
Procedure: (atelocollagen group)
Epidural nerve block and atelocollagen injection into the multifidus muscle were performed sequentially. The target level is determined by the clinician by combining the pre-MRI and the patient's symptoms. All procedures are performed under the guidance of fluroscopy. For epidural nerve block, use 10cc of 0.9% normal saline mixed with 3000IU of hyaluronidase to be injected. After the epidural nerve block, a solution of 1 mL of atelocollagen mixed with 1 mL of 1% lidocaine is injected into the multifidus muscle to complete the entire procedure.
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Outcome Measures
Primary Outcome Measures
- cross-sectional area of the multifidus muscle [28 days after atelocollagen injection]
Changes in the cross-sectional area of the multifidus muscle at the 4th week of the intervention compared to before the intervention (measured value using ultrasound at outpatient).
Secondary Outcome Measures
- numeric rating score [28 days after atelocollagen injection]
numeric rating score, Score range from 0 to 100. Higher scores mean a worst outcome.
- oswestry disability index [28 days after atelocollagen injection]
oswestry disability index, Score range from 0 to 50. Higher scores mean a worst outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients scheduled for epidural nerve block for lower back pain
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Patients over 21 years of age
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Back pain lasting more than 6 months
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Patients with ineffective or insignificant effects of conventional drugs and nerve block for back pain
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Patients with spinal stenosis or disc herniation at the lumbar 4-5 or lumbar 5-sacral 1 level on MRI, and the cross-sectional area of the multifidus muscle at the lesion site is less than 5 cm2 when measured by ultrasound.
Exclusion Criteria:
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When the degree of low back pain is 3 points or less on the 11-scale numeric rating scale (hereafter NRS)
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If lower back pain has rapidly worsened within the last week
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If you have other diseases that may cause low back pain: osteoarthritis of the hip joint, cancer, inflammatory arthritis, spondylitis, fibromyalgia, complex regional pain syndrome, herpes zoster, postherpetic neuralgia, etc.
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When a diagnostic epidural nerve block is planned
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In the case of receiving conservative treatment, procedure, or surgery other than oral drugs such as epidural nerve block or proliferation treatment for the treatment of lower back pain within 4 weeks of screening
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When the low back pain assessed by NRS decreased by more than 50% after epidural nerve block in screening
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If back surgery is planned within 3 months of the procedure
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When NRS and ODI measurements cannot be made
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When collagen injection is contraindicated (eg when allergic to swine)
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Pregnant women
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If you cannot read or agree to the consent form
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If you are unable to sign the consent form yourself
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Ji Yeong Kim | Seoul | Korea, Republic of | 06273 |
Sponsors and Collaborators
- Gangnam Severance Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3-2021-0180