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Combination Therapy With Atelocollagen in Epidural Nerve Block

Primary Purpose

Degenerative Lumbar Spine Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
(atelocollagen group)
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Lumbar Spine Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ji Yeong Kim

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atelocollagen group

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

numeric rating score
numeric rating score, Score range from 0 to 100. Higher scores mean a worst outcome.
oswestry disability index
oswestry disability index, Score range from 0 to 50. Higher scores mean a worst outcome.

Full Information

First Posted
July 22, 2021
Last Updated
August 7, 2022
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05014945
Brief Title
Combination Therapy With Atelocollagen in Epidural Nerve Block
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Lumbar Spine Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with chronic low back pain due to degenerative spinal disease for more than 6 months
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atelocollagen group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
(atelocollagen group)
Intervention Description
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.
Primary Outcome Measure Information:
Title
cross-sectional area of the multifidus muscle
Description
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).
Time Frame
28 days after atelocollagen injection
Secondary Outcome Measure Information:
Title
numeric rating score
Description
numeric rating score, Score range from 0 to 100. Higher scores mean a worst outcome.
Time Frame
28 days after atelocollagen injection
Title
oswestry disability index
Description
oswestry disability index, Score range from 0 to 50. Higher scores mean a worst outcome.
Time Frame
28 days after atelocollagen injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for epidural nerve block for lower back pain Patients over 21 years of age Back pain lasting more than 6 months Patients with ineffective or insignificant effects of conventional drugs and nerve block for back pain 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: When the degree of low back pain is 3 points or less on the 11-scale numeric rating scale (hereafter NRS) If lower back pain has rapidly worsened within the last week 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. When a diagnostic epidural nerve block is planned 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 When the low back pain assessed by NRS decreased by more than 50% after epidural nerve block in screening If back surgery is planned within 3 months of the procedure When NRS and ODI measurements cannot be made When collagen injection is contraindicated (eg when allergic to swine) Pregnant women If you cannot read or agree to the consent form If you are unable to sign the consent form yourself
Facility Information:
Facility Name
Ji Yeong Kim
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Combination Therapy With Atelocollagen in Epidural Nerve Block

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