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Completed

NCT Number: NCT04933838

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

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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).

Primary outcomes

  1. Pain changes in low back pain

    Time frame: 4 weeks after last intervention

    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.

Secondary outcomes

  1. Pain changes in low back pain

    Time frame: 12 weeks after last intervention

    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 i

  2. Cross-sectional area

    Time frame: 4, 12 weeks after last intervention

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

  3. Oswestry Disability Index(ODI) score

    Time frame: 4, 12 weeks after last intervention

    The changes of ODI score after intervention between two groups.

  4. Satisfaction (participants)

    Time frame: 4 weeks after first intervention

    5-pointed satisfaction scale of intervention (participants)

  5. Satisfaction (pain physician)

    Time frame: 4 weeks after first intervention

    5-pointed satisfaction scale of intervention (pain physician)

  6. Pain related to intervention

    Time frame: 4 weeks after first 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

  7. Medication

    Time frame: 12 weeks after last intervention

    The changes in medication

Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Registry information

Official study title

Evaluation of an Effectiveness and Safety of Atelocollagen in the Management of Chronic Non-specific Low Back Pain: A Prospective, Randomized, Comparative Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2021
Registry last updated
Sep 14, 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.

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