Skip to content

Combination Therapy With Atelocollagen in Epidural Nerve Block

CompletedNot applicableNCT05014945
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

"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.

Study details

Official title
Effect of Combination Therapy With Atelocollagen in Epidural Nerve Block in Patients With Chronic Low Back Pain From Degenerative Lumbar Spine: Pilot Study
Conditions
  • Degenerative Lumbar Spine Disease
Interventions
  • Procedure: (atelocollagen group)
Sponsor
Gangnam Severance Hospital
Start date
2021-08-16
Primary completion
2022-05-27
Sex
All
Age range
from 21 Years
Results posted
No results posted in this snapshot
Countries
South Korea
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05014945