Low Back PainNCT04933838
Effectiveness and Safety of Atelocollagen in the Management of Chronic Non-specific Low Back Pain
A study testing atelocollagen in people with Low Back Pain, run by Seoul National University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- atelocollagen
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2021to 27 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- atelocollagen
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | 1% licocaine 3 mL + Normal saline 3 mL mixture Receives: Device: atelocollagen |
| Atelocollagen group | Experimental | 1% lidocaine 3 mL + atelocollagen 3 mL mixture Receives: Device: atelocollagen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after last intervention
Secondary outcomes (7)
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
Measured: 12 weeks after last intervention
Cross-sectional area
The changes of cross-sectional area using ultrasound after intervention between two groups.
Measured: 4, 12 weeks after last intervention
Oswestry Disability Index(ODI) score
The changes of ODI score after intervention between two groups.
Measured: 4, 12 weeks after last intervention
Satisfaction (participants)
5-pointed satisfaction scale of intervention (participants)
Measured: 4 weeks after first intervention
Satisfaction (pain physician)
5-pointed satisfaction scale of intervention (pain physician)
Measured: 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
Measured: 4 weeks after first intervention
Medication
The changes in medication
Measured: 12 weeks after last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jul 2021
- Primary completion3 Mar 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933838
- Sponsor's protocol ID
- 2011-183-1177
- Status last verified
- Sep 2022
- First submitted
- 1 Jun 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04933838
- Acronym / sponsor ID
- 2011-183-1177
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Device: atelocollagen1% licocaine 3 mL + Normal saline 3 mL mixture |
| Atelocollagen group | Experimental | Device: atelocollagen1% lidocaine 3 mL + atelocollagen 3 mL mixture |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atelocollagenThis 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). | Device | Atelocollagen group, Control Group |
Primary outcome
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.
7 secondary outcomes
Pain changes in low back pain
Time frame: 12 weeks after last intervention
Cross-sectional area
Time frame: 4, 12 weeks after last intervention
Oswestry Disability Index(ODI) score
Time frame: 4, 12 weeks after last intervention
Satisfaction (participants)
Time frame: 4 weeks after first intervention
Satisfaction (pain physician)
Time frame: 4 weeks after first intervention
Pain related to intervention
Time frame: 4 weeks after first intervention
Medication
Time frame: 12 weeks after last intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atelocollagen in people with Low Back Pain, run by Seoul National University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain changes in low back pain (time frame: 4 weeks after last intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.