Back to resultsEffectiveness and Safety of Atelocollagen in the Management of Chronic Non-specific Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
atelocollagen
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Group
Atelocollagen group
Arm Description
1% licocaine 3 mL + Normal saline 3 mL mixture
1% lidocaine 3 mL + atelocollagen 3 mL mixture
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 i
Cross-sectional area
The changes of cross-sectional area using ultrasound after intervention between two groups.
Oswestry Disability Index(ODI) score
The changes of ODI score after intervention between two groups.
Satisfaction (participants)
5-pointed satisfaction scale of intervention (participants)
Satisfaction (pain physician)
5-pointed satisfaction scale of intervention (pain physician)
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
Medication
The changes in medication
Full Information
NCT ID
NCT04933838
First Posted
June 1, 2021
Last Updated
September 12, 2022
Sponsor
Seoul National University
1. Study Identification
Unique Protocol Identification Number
NCT04933838
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
March 3, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
1% licocaine 3 mL + Normal saline 3 mL mixture
Arm Title
Atelocollagen group
Arm Type
Experimental
Arm Description
1% lidocaine 3 mL + atelocollagen 3 mL mixture
Intervention Type
Device
Intervention Name(s)
atelocollagen
Intervention Description
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 Outcome Measure Information:
Title
Pain changes in low back pain
Description
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 Outcome Measure Information:
Title
Pain changes in low back pain
Description
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
Time Frame
12 weeks after last intervention
Title
Cross-sectional area
Description
The changes of cross-sectional area using ultrasound after intervention between two groups.
Time Frame
4, 12 weeks after last intervention
Title
Oswestry Disability Index(ODI) score
Description
The changes of ODI score after intervention between two groups.
Time Frame
4, 12 weeks after last intervention
Title
Satisfaction (participants)
Description
5-pointed satisfaction scale of intervention (participants)
Time Frame
4 weeks after first intervention
Title
Satisfaction (pain physician)
Description
5-pointed satisfaction scale of intervention (pain physician)
Time Frame
4 weeks after first intervention
Title
Pain related to intervention
Description
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
Time Frame
4 weeks after first intervention
Title
Medication
Description
The changes in medication
Time Frame
12 weeks after last intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety of Atelocollagen in the Management of Chronic Non-specific Low Back Pain
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