Combination Therapy With Atelocollagen in Epidural Nerve Block

• Sponsor: Gangnam Severance Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05014945
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 9.3
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Lumbar Spine Disease	Procedure: (atelocollagen group)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Patients with chronic low back pain due to degenerative spinal disease for more than 6 monthsPatients with chronic low back pain due to degenerative spinal disease for more than 6 months
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Aug 16, 2021
• Actual Primary Completion Date: May 27, 2022
• Actual Study Completion Date: May 27, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. numeric rating score [28 days after atelocollagen injection]

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

2. oswestry disability index [28 days after atelocollagen injection]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ji Yeong Kim	Seoul		Korea, Republic of	06273

Sponsors and Collaborators

• Gangnam Severance Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ji Yeong Kim, Associate Professor, Gangnam Severance Hospital
• ClinicalTrials.gov Identifier: NCT05014945
• Other Study ID Numbers: 3-2021-0180
• First Posted: Aug 20, 2021
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spinal Diseases

Study Results

No Results Posted as of Aug 9, 2022