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

NCT04933838 | Completed

• 1 other identifier: 2011-183-1177
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks after last intervention

Secondary Outcomes (7)

• Pain changes in low back pain

  12 weeks after last intervention

• Cross-sectional area

  4, 12 weeks after last intervention

• Oswestry Disability Index(ODI) score

  4, 12 weeks after last intervention

• Satisfaction (participants)

  4 weeks after first intervention

• Satisfaction (pain physician)

  4 weeks after first intervention

Study Arms (2)

Control Group

PLACEBO COMPARATOR

1% licocaine 3 mL + Normal saline 3 mL mixture

Device: atelocollagen

Atelocollagen group

EXPERIMENTAL

1% lidocaine 3 mL + atelocollagen 3 mL mixture

Device: atelocollagen

Interventions

atelocollagen DEVICE

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).

Atelocollagen group; Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Seoul National University: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 22, 2021
• Study Start: July 1, 2021
• Primary Completion: March 3, 2022
• Study Completion: April 27, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

KR (1)