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Effectiveness and Safety of Atelocollagen in the Management of Chronic Non-specific Low Back Pain

NCT04933838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-09-14

No results posted yet for this study

Summary

The purpose of this study was to evaluate the effectiveness and safety of atelocollagen in the management of chronic low back pain with sarcopenia due to degenerative changes.

Conditions

  • Low Back Pain

Interventions

DEVICE

atelocollagen

This collagen-contained product is used to supplement tendon, ligament, muscle, and (biological) membrane that is missing or damaged during internal/surgical treatment and surgery. Patients with chronic low back pain are randomized after obtaining informed consent for the study. Participants are divided into group A (atelocollagen) and group B (control). A physical examination for lumbar pain was performed and evaluated trigger points in multifidus, erector spinae, and quadratus lumborum muscles. After physical exam, cross sectional area of each muscle is measured by ultrasound in both gorup. Group A will receive atelocollagen mixture (atelocollagen 3 mL + 1% lidocaine 3 mL) and group B will receive local anesthetics only (Normal saline 3 mL + 1% lidocaine 3 mL). Each participants will be injected 1 mL of injectate into each muscle on both sides (total 6 mL).

Sponsors & Collaborators

  • Seoul National University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-03-03
Completion
2022-04-27

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04933838 on ClinicalTrials.gov