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

Seoul National University34 enrolled

Overview

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.

Patients with chronic low back pain are enrolled and divided into group A (atelocollagen) and group B (control) through randomization after obtaining informed consent. Investigators record tender points for the multifidus, erector spinae, and quadratus lumborum muscles by physical examination. Investigators evaluate each muscle using ultrasound according to the assignment of each group, and apply atelocollagen mixture (atelocollagen 3 mL + 1% lidocaine 3 mL) or local anesthetics only (normal saline 3 mL + 1% lidocaine 3 mL) to each muscle on both sides. The subject of the study performs a total of 3 injections at intervals of 2 weeks, and each measurement variable is collected by visiting 4 weeks and 12 weeks after the last injection. Changing medications or additive interventions are not allowed before 4 weeks after last injection. Only acetaminophen is allowed as a rescue drug.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Low Back Pain

Interventions

atelocollagenDEVICE

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).

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Non-specific low back pain with persistent paraspinal tenderness of NRS 4 or higher despite conservative treatment (including physical therapy, exercise therapy, oral drug administration, and epidural block) for at least 3 months. Adults 19 years of age or older Exclusion Criteria: \- Systemic or local infection Coagulopathy Patients whose structure is difficult to confirm on ultrasound due to significant deformity of the lumbar spine Neoplasm of spine Cognitive disorder Patients with hypersensitivity to local anesthetics or amide-based local anesthetics Patients those who are allergic to or sensitive to atelocollagen ingredients or pork Women who are pregnant, lactating, or planning to become pregnant during the clinical period, or women of childbearing age who are not using available contraceptive methods Those who participated in other clinical trials within 30 days prior to screening or 5 times the half-life of the investigational drug in the clinical trial in which they participated, whichever is longer, whichever is longer Patients with serious systemic diseases

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Pain changes in low back pain

The changes of the 11-point Numeric Rating Scale(NRS) pain score (numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")) after intervention between two groups.

Time frame: 4 weeks after last intervention

Secondary Outcomes

Pain changes in low back pain

Time frame: 12 weeks after last intervention

Cross-sectional area

The changes of cross-sectional area using ultrasound after intervention between two groups.

Time frame: 4, 12 weeks after last intervention

Oswestry Disability Index(ODI) score

The changes of ODI score after intervention between two groups.

Time frame: 4, 12 weeks after last intervention

Satisfaction (participants)

5-pointed satisfaction scale of intervention (participants)

Time frame: 4 weeks after first intervention

Satisfaction (pain physician)

5-pointed satisfaction scale of intervention (pain physician)

Time frame: 4 weeks after first intervention

Pain related to intervention

The 11-point Numeric Rating Scale(NRS) pain score (numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")) related to intervention

Data from ClinicalTrials.gov

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