Skip to main content
OpenTrials
Completed

NCT Number: NCT05014945

Combination Therapy With Atelocollagen in Epidural Nerve Block

"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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ji Yeong Kim

Seoul, 06273, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

(atelocollagen group)

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.

Primary outcomes

  1. cross-sectional area of the multifidus muscle

    Time frame: 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 outcomes

  1. numeric rating score

    Time frame: 28 days after atelocollagen injection

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

  2. oswestry disability index

    Time frame: 28 days after atelocollagen injection

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

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2021
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.