Lumbar Disc Prolapse With RadiculopathyNCT04833270
Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study
A study testing KM non-pharmacological treatment group and Pharmacological treatment group in people with Lumbar Disc Prolapse With Radiculopathy, run by Jaseng Hospital of Korean Medicine at 1 site in South Korea.
Trial summary
This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Lumbar Disc Prolapse With Radiculopathy
- What is being tested?
- KM non-pharmacological treatment group and Pharmacological treatment group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jul 2021to 28 Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days.
- Onset time of radiating pain occurred within 12 weeks.
- Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)
- 19-70 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 or pharmacopuncture 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
1 site in 1 country.
About this study
This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.
Read the detailed description
Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and pharmacological treatment group. Participants of each group will receive twice a week for total 8 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific intervention and dosage of pharmacological and non-pharmacological treatment.
- Conditions
- Lumbar Disc Prolapse With Radiculopathy
- Being tested
- KM non-pharmacological treatment group, Pharmacological treatment group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KM non-pharmacological treatment groupOther
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 treatment groupOther
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 |
|---|---|---|
| KM non-pharmacological treatment group | Experimental | Non-pharmacological treatment including Korean medicine will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form. Receives: Other: KM non-pharmacological treatment group |
| Pharmacological treatment group | Active comparator | Pharmacological treatment will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form. Receives: Other: Pharmacological treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS) of radiating pain in lower extremities
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.
Measured: week 9
Secondary outcomes (9)
Numeric rating scale (NRS) of radiating pain in lower extremities
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.
Measured: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Numeric rating scale (NRS) of low-back pain
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 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 leg radiating pain
Visual analogue scale of 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
Visual analogue scale (VAS) of low-back pain
Visual analogue scale of 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
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
Fear-Avoidance Beliefs Questionnaire (FABQ)
FABQ is one of pateint-reported outcome questionnaire which consists of total 16 questions. Through FABQ, the investigator can evaluate fear avoidance responses, especially in physical and occupational activity domain for patients with low-back pain
Measured: week 1, 9, 14, 27
Patient Global Impression of Change (PGIC)
Participants rate the improvement after treatment on a 7-point Likert scale(1, very much improved; 2, much improved; 3, minimally improved; 4, nochange; 5, minimally worse; 6, much worse; or 7, very much worse.)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start9 Jul 2021
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc Prolapse With RadiculopathyStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Hospital of Korean Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Responsible party
- Principal investigator, Kyoung Sun Park, Jaseng Hospital of Korean Medicine
- Investigators
- Kyoung Sun Park, KMD,Ph.D, Principal investigator, Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833270
- Sponsor's protocol ID
- JS-CT-2021-01
- Status last verified
- Sep 2022
- First submitted
- 4 Apr 2021
- Last updated
- 27 Sep 2022
- 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 27 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study
- ClinicalTrials.gov ID
- NCT04833270
- Acronym / sponsor ID
- JS-CT-2021-01
- Conditions
- Lumbar Disc Prolapse With Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jaseng Hospital of Korean MedicineUniversity, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 6 Apr 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 is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.
Detailed description
Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and pharmacological treatment group. Participants of each group will receive twice a week for total 8 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific intervention and dosage of pharmacological and non-pharmacological treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KM non-pharmacological treatment group | Experimental | Other: KM non-pharmacological treatment groupNon-pharmacological treatment including Korean medicine will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form. |
| Pharmacological treatment group | Active comparator | Other: Pharmacological treatment groupPharmacological treatment will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form. |
Who may qualify
- Ages
- 19 to 70 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 5 or more for recent 3 serial days.
- Onset time of radiating pain occurred within 12 weeks.
- Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)
- 19-70 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 |
|---|---|---|
| KM non-pharmacological treatment groupThis 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. | Other | KM non-pharmacological treatment group |
| Pharmacological treatment groupThis 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. | Other | Pharmacological treatment group |
Primary outcome
Numeric rating scale (NRS) of radiating pain in lower extremities
Time frame: week 9
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.
9 secondary outcomes
Numeric rating scale (NRS) of radiating pain in lower extremities
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
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 leg radiating pain
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Visual analogue scale (VAS) of low-back pain
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Oswestry Disability Index (ODI)
Time frame: week 1, 5, 9, 14, 27
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: week 1, 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
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 27 Sep 2022.
- 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, KMD,Ph.D principal investigator
Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KM non-pharmacological treatment group and Pharmacological treatment group in people with Lumbar Disc Prolapse With Radiculopathy, run by Jaseng Hospital of Korean Medicine 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 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 27 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. 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?
Numeric rating scale (NRS) of radiating pain in lower extremities (time frame: week 9). 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 27 Sep 2022.