Combination Therapy With Atelocollagen in Epidural Nerve Block

NCT ID: NCT05014945

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2022-05-27

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.

Conditions

Degenerative Lumbar Spine Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

(atelocollagen group)

Intervention Type: PROCEDURE

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.

Interventions

(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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ji Yeong Kim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ji Yeong Kim

Seoul, , South Korea

Countries

South Korea

Other Identifiers

3-2021-0180

Identifier Type: -

Identifier Source: org_study_id