Lumbar Disc HerniationNCT05003726
Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation
A study testing non-pharmacological treatment and pharmacological treatment in people with Lumbar Disc Herniation and Radiculopathy Lumbar, run by Jaseng Hospital of Korean Medicine at 4 sites in South Korea.
Trial summary
This study is a 2-armed parallel, multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Lumbar Disc Herniation, Radiculopathy Lumbar
- What is being tested?
- non-pharmacological treatment and pharmacological treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 15 Oct 2021to 11 May 2023
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Numeric rating scale (NRS) score of radiating pain or low back pain 5 or more for recent 3 serial days.
- Onset time of radiating pain occurred 3 months before enrollment.
- Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI), which can explain lower extremity radiation pain and back pain
- 19-69 years old
- participants who agreed and signed informed consent form
Who cannot join
- Spine metastasis of cancer, acute fracture of spine, or spine dislocation
- Progressive neurologic deficits or severe neurologic deficits
- Soft tissue diseases that can induce low back pain(ie. cancer, fibromyalgia, rheumatoid arthritis, gout,etc)
- Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
- Concurrent use of steroids, immunosuppressants, orpsychotropic medications or any other medication that can interrupt the study result
- Hemorrhagic disease, severe diabetes or taking anticoagulant drug
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- Participants who took NSAIDs within 1 week
- Pregnant or lactating women
- Participants who had undergone lumbar surgery within 3 months
- Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
- Participants who can not write informed consent
- Participants who is difficult to participate in the trial according to investigator's decision
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, 14598
Haeundae Jaseng Hospital of Korean Medicine
Busan
Daejeon Jaseng Hospital of Korean Medicine
Daejeon
Jaseng Hospital of Korean Medicine
Seoul
About this study
Official title: Comparative Effectiveness of Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation : a Multi-centered, Pragmatic Randomized Controlled, Parallel-grouped Pilot Study
This study is a 2-armed parallel, multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation.
Read the detailed description
This study is a multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation. The participants who voluntarily signed informed consent will be randomly assigned in 1:2 ratio to non-pharmacological group and pharmacological group and will receive the 8 weeks of intervention.
- Conditions
- Lumbar Disc Herniation, Radiculopathy Lumbar
- Being tested
- non-pharmacological treatment, pharmacological treatment
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-pharmacological treatmentProcedure or surgery
This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject.
pharmacological treatmentProcedure or surgery
This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject.
| Study group | Role | What they receive |
|---|---|---|
| Non-pharmacological group including KM | Experimental | Non-pharmacological treatment including Korean medicine will be implemented to the participants for total 8 weeks. This is a pragmatic clinical trial, and the specific intervention will be determined according to the physician's choice. intervention data will be recorded in the case report form. Receives: Procedure: non-pharmacological treatment |
| Pharmacological group | Active comparator | Pharmacological treatment will be implemented to the participants for total 8 weeks. This is a pragmatic clinical trial, and the specific intervention will be determined according to the physician's choice. intervention data will be recorded in the case report form. Receives: Procedure: pharmacological treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry disability index (ODI)
ODI is a functional disability questionnaire. The possible range of eachitem score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome)
Measured: week 1, 5, 9, 14, 27
Secondary outcomes (10)
Numeric rating scale (NRS) of low back pain
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Measured: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Visual analogue scale (VAS) of low back pain and radiating pain in lower extermities
Visual analogue scale of low back pain and radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome.
Measured: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Numeric rating scale (NRS) of radiating pain in lower extremities
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Measured: week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Patient global impression of change (PGIC)
Participants rate the global impression of improvement after treatment on a 7-point Likert scale.
Measured: week 9, 14, 27
Short form-12 health survey version 2 (SF-12 v2)
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Measured: week 1, 5, 9, 14, 27
EuroQol-5 Dimension (EQ-5D-5L)
The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)
Measured: week 1, 5, 9, 14, 27
Credibility and Expectancy
To evaluate participants' expectations for treatment, the nine-point scale(Likert scale) is used to evaluate them. During the screening visit, the candidates will choose their scores in response to the question, "How much do you think non-drug therapy, including Korean medical treatment, or medication will relieve your symptoms?" (1 = not at all, 5 = somewhat, and 9 = very much)
Measured: week -1
Evaluation question
Use a questionnaire that measures official unofficial medical expenses, non-medical expenses, time costs, and productivity loss costs developed separately to measure cost items. Informal medical expenses, such as purchasing pars or medical devices, include transportation, patient time, transportation, patient time, and nursing costs are non-medical expenses. Productivity loss costs refer to the cost of economic loss caused by the disease itself or by the inability to participate in labor due to premature death from the disease. To calculate the cost of productivity loss, we will use the Work Productivity and Activity Impairment questionnair (WPAI) to convert it into cost-effectiveness analysis.
Measured: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Drug Consumption
The type and dose of prescribed drugs or relief drugs due to the active history of drugs taken during the study period are observed through a questionnaire when visiting the study subjects. Other than the medication you are taking, physical therapy, injection therapy, etc. should be recorded in the number of times.
Measured: week -1, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Adverse events
Safety will be verified by comparing the occurrence of adverse events between the two groups. The researcher evaluates each treatment method and its adverse events on a six-step scale according to the WHO-UMC UMC causality assessment system (1=definitive linked, 2=provocatively linked, 4=probably not related, 5=definitive not related, 5=definitive not related to the study), and all adverse events are classified into three stages by the Spilker taxonomy (Mild(1)): If treatment is not required and does not significantly impair the normal life function, Moderate(2): may significantly impair normal life function, and may require treatment, and Severe(3): severe adverse events require high treatment, and side effects remain.
Measured: week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start15 Oct 2021
- Primary completion4 Jan 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Hospital of Korean Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyoung Sun Park, Jaseng Hospital of Korean Medicine
- Investigators
- Kyoung Sun Park, Ph.D, Principal investigator, Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003726
- Sponsor's protocol ID
- JS-CT-2021-07
- Status last verified
- May 2023
- First submitted
- 11 Aug 2021
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation : a Multi-centered, Pragmatic Randomized Controlled, Parallel-grouped Pilot Study
- ClinicalTrials.gov ID
- NCT05003726
- Acronym / sponsor ID
- JS-CT-2021-07
- Conditions
- Lumbar Disc Herniation, Radiculopathy Lumbar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jaseng Hospital of Korean MedicineUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 12 Aug 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.
This study is a 2-armed parallel, multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation.
Detailed description
This study is a multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation. The participants who voluntarily signed informed consent will be randomly assigned in 1:2 ratio to non-pharmacological group and pharmacological group and will receive the 8 weeks of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pharmacological group including KM | Experimental | Procedure: non-pharmacological treatmentNon-pharmacological treatment including Korean medicine will be implemented to the participants for total 8 weeks. This is a pragmatic clinical trial, and the specific intervention will be determined according to the physician's choice. intervention data will be recorded in the case report form. |
| Pharmacological group | Active comparator | Procedure: pharmacological treatmentPharmacological treatment will be implemented to the participants for total 8 weeks. This is a pragmatic clinical trial, and the specific intervention will be determined according to the physician's choice. intervention data will be recorded in the case report form. |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Numeric rating scale (NRS) score of radiating pain or low back pain 5 or more for recent 3 serial days.
- Onset time of radiating pain occurred 3 months before enrollment.
- Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI), which can explain lower extremity radiation pain and back pain
- 19-69 years old
- participants who agreed and signed informed consent form
Key exclusion criteria (12 listed)
- Spine metastasis of cancer, acute fracture of spine, or spine dislocation
- Progressive neurologic deficits or severe neurologic deficits
- Soft tissue diseases that can induce low back pain(ie. cancer, fibromyalgia, rheumatoid arthritis, gout,etc)
- Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
- Concurrent use of steroids, immunosuppressants, orpsychotropic medications or any other medication that can interrupt the study result
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 |
|---|---|---|
| non-pharmacological treatmentThis is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject. | Procedure or surgery | Non-pharmacological group including KM |
| pharmacological treatmentThis is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject. | Procedure or surgery | Pharmacological group |
Primary outcome
Oswestry disability index (ODI)
Time frame: week 1, 5, 9, 14, 27
ODI is a functional disability questionnaire. The possible range of eachitem score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome)
10 secondary outcomes
Numeric rating scale (NRS) of low back pain
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Visual analogue scale (VAS) of low back pain and radiating pain in lower extermities
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Numeric rating scale (NRS) of radiating pain in lower extremities
Time frame: week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Patient global impression of change (PGIC)
Time frame: week 9, 14, 27
Short form-12 health survey version 2 (SF-12 v2)
Time frame: week 1, 5, 9, 14, 27
EuroQol-5 Dimension (EQ-5D-5L)
Time frame: week 1, 5, 9, 14, 27
Credibility and Expectancy
Time frame: week -1
Evaluation question
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Drug Consumption
Time frame: week -1, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Adverse events
Time frame: week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
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 30 May 2023.
- Individual participant dataSharing planned: No
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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.
Kyoung Sun Park, Ph.D principal investigator
Jaseng Hospital of Korean Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-pharmacological treatment and pharmacological treatment in people with Lumbar Disc Herniation and Radiculopathy Lumbar, run by Jaseng Hospital of Korean Medicine at 4 sites 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 5 inclusion and 12 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 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Oswestry disability index (ODI) (time frame: week 1, 5, 9, 14, 27). 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 30 May 2023.