Combination Therapy With Atelocollagen in Epidural Nerve Block

Not Applicable

Completed

• Conditions: Degenerative Lumbar Spine Disease

• Registration Number: NCT05014945
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-08-13
• Study Start: 2021-08-16
• Study First Posted: 2021-08-20
• Primary Completion: 2022-05-27
• Study Completion: 2022-05-27
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-07
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Ji Yeong Kim; 🇰🇷 Seoul, Korea, Republic of