Clinical trial NCT04933838: Effectiveness and Safety of Atelocollagen in the Management of Chronic Non-specific Low Back Pain
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain changes in low back pain
timeFrame: 4 weeks after last intervention
Secondary outcomes:
measure: Pain changes in low back pain
timeFrame: 12 weeks after last intervention
measure: Cross-sectional area
timeFrame: 4, 12 weeks after last intervention
measure: Oswestry Disability Index(ODI) score
timeFrame: 4, 12 weeks after last intervention
measure: Satisfaction (participants)
timeFrame: 4 weeks after first intervention
measure: Satisfaction (pain physician)
timeFrame: 4 weeks after first intervention
measure: Pain related to intervention
timeFrame: 4 weeks after first intervention
measure: Medication
timeFrame: 12 weeks after last intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: