Combination Therapy With Atelocollagen in Epidural Nerve Block

Effect of Combination Therapy With Atelocollagen in Epidural Nerve Block in Patients With Chronic Low Back Pain From Degenerative Lumbar Spine: Pilot Study

"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 Overview

• Status: Completed
• Conditions: Degenerative Lumbar Spine Disease
• Intervention / Treatment: Procedure: (atelocollagen group)

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06273
    • Ji Yeong Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cross-sectional area of the multifidus muscle	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).	28 days after atelocollagen injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
numeric rating score	numeric rating score, Score range from 0 to 100. Higher scores mean a worst outcome.	28 days after atelocollagen injection
oswestry disability index	oswestry disability index, Score range from 0 to 50. Higher scores mean a worst outcome.	28 days after atelocollagen injection

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): May 27, 2022
• Study Completion (Actual): May 27, 2022

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 7, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: 3-2021-0180

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No