Degenerative Lumbar Spine Disease
Conditions
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.
Interventions
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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients with chronic low back pain due to degenerative spinal disease for more than 6 months
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients scheduled for epidural nerve block for lower back pain 2. Patients over 21 years of age 3. Back pain lasting more than 6 months 4. Patients with ineffective or insignificant effects of conventional drugs and nerve block for back pain 5. 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
1. When the degree of low back pain is 3 points or less on the 11-scale numeric rating scale (hereafter NRS) 2. If lower back pain has rapidly worsened within the last week 3. 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. 4. When a diagnostic epidural nerve block is planned 5. 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 6. When the low back pain assessed by NRS decreased by more than 50% after epidural nerve block in screening 7. If back surgery is planned within 3 months of the procedure 8. When NRS and ODI measurements cannot be made 9. When collagen injection is contraindicated (eg when allergic to swine) 10. Pregnant women 11. If you cannot read or agree to the consent form 12. If you are unable to sign the consent form yourself
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed