Spondylolisthesis, Lumbosacral RegionNCT03107468
Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis
A study testing Mokhuri intensive treatment and Non-surgical conventional standard treatment in people with Spondylolisthesis, Lumbosacral Region, run by Kim Ki Ok at 2 sites in 2 countries.
Trial summary
This is a clinical trial for evaluating the safety and effectiveness of the Mokhuri intensive treatment program regarding pain and function before and after treatment between a group receiving the Mokhuri intensive treatment program (Chuna, acupuncture, and patient education) for five weeks and another group receiving… Read more about this study
- Who is it for?
- Ages 19 to 78 years
- Conditions the study is for
- Spondylolisthesis, Lumbosacral Region
- What is being tested?
- Mokhuri intensive treatment and Non-surgical conventional standard treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Dec 2017to 31 Dec 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 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with all the following requirements will be included as appropriate subjects in the clinical trial:
- Those aged from 19 to 78 years
- Those with a diagnosis of degenerative lumbar spinal spondylolisthesis and have low back pain, lower limb radiating pain, or leg discomfort when standing or walking with severity of at least 50 in a 0 to 100 VAS for each symptom
- Those suffering from neurologic claudication or radicular pain at least for one year
- Those with neurogenic claudication within five minutes when walking on a treadmill at the speed of 1.5 miles per hour
- Those not receiving epidural injection treatments within the past one month
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- Those who have not undergone lumbar surgery
- Those who confirmed spondylolisthesis on L-spine AP, lateral \& both oblique views
- Those who weigh 250 lbs (113.398 kg) or less
- Those who are 2.1 m (6.890 ft) in height or shorter
- Those agreeing to participate in this clinical trial after receiving a thorough explanation of the purposes and characteristics of the trial and who have also signed the written informed consent form.
Who cannot join
- Subjects will be excluded for the following conditions:
- Those with a history of diseases in the past or in the present that cause ambulatory functional disability
- Those with knee joint and hip joint disorders that severely limit walking (i.e. moderate or severe osteoarthritis in the knee or hip joints)
- Those who has been diagnosed as peripheral blood vessel diseases or vascular diseases in the past, shows an ankle-brachial index (ABI) below 0.9 or is diagnosed as peripheral artery disease by Doppler ultrasonography of lower limbs, if necessary
- Those with severe diseases (cardiac disorders or renal insufficiency) such that the ambulatory evaluation is not attainable
- Those with other specific spinal diseases (ankylosing spondylitis, spinal osteomyelitis, metabolic diseases, severe osteoporosis, etc.)
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- Those with severe neurological defects including foot drop or cauda equina syndrome
- Those with spinal instability confirmed by L-spine x-ray flexion and extension views. Spinal instability will be defined as observing one or more of the following: 4.5 mm sagittal plane translation, 20 degrees of sagittal plane rotation at L4-5, or 25 degrees of sagittal plane rotation at L5-S1.
- Those with malignancy
- Those with psychiatric conditions such as major depressive disorder and anxiety disorder in the past or present (e.g., panic disorder, episodes of mania, delusion, and schizophrenia)
- Those using narcotic analgesics, including the external dosage form or patch
- Those on medications for respiratory diseases including gastritis, stomach ulcer, and irritable bowel syndrome
- Pregnant women, lactating women, or those planning to become pregnant
- Those who appear likely to encounter difficulties in adhering to this protocol such as those regarding treatment, hospitalization, or preparation for the survey
- Those subjects who the clinical investigators judge to be inappropriate
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: The Effectiveness and Safety of Traditional Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis: a Randomized Controlled International Collaborative Multi-center Trial
This is a clinical trial for evaluating the safety and effectiveness of the Mokhuri intensive treatment program regarding pain and function before and after treatment between a group receiving the Mokhuri intensive treatment program (Chuna, acupuncture, and patient education) for five weeks and another group receiving non-surgical conventional standard treatment (drugs for pain relief, epidural steroid injection treatment, and physical therapy).
The trial will be conducted through international cooperation between Mayo Clinic in the United States and Mokhuri Oriental Medicine Hospital in Korea. All subjects in Korea and the US will be selected based on the same inclusion criteria and exclusion criteria. All subjects in the treatment arm will receive the same treatment in Korea and the US. In collaboration and with the support of Mayo Clinic's Department of Integrative Medicine and Health, and to ensure treatment consistency between Korea and the US, an acupuncturist from the USA will travel to Korea and train on-site for one month in Mokhuri hospital.
The trial subjects who agree to participate in the clinical trial after providing informed consent will receive the required examinations and tests according to the clinical trial plan. If they are appropriate for this clinical trial and eligible based on the Inclusion and exclusion criteria, they will be randomly assigned to the group that will undergo the focused Mokhuri intensive treatment program and to the group that will receive non-surgical conventional treatment on their second visit. All the subjects in this study will be educated regarding the study procedure and scheduled visits and will participate in the allocated treatments for five weeks. Afterwards, clinical outcomes of both groups will be evaluated after end of the treatments from between a week and five weeks (within +7 days). The clinical trial ends after the follow-up evaluations that will take place 12 weeks, 24 weeks, 48 weeks, and 96 weeks after the end of the treatment evaluation.
- Conditions
- Spondylolisthesis, Lumbosacral Region
- Being tested
- Mokhuri intensive treatment, Non-surgical conventional standard treatment
- Keywords
- Non-surgical treatment, Acupuncture, Chuna, Physiotherapy, Epidural steroid injection
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mokhuri intensive treatmentOther
Patients in this arm will be treated with acupuncture, Chuna and patient consultation during 5 weeks. For acupuncture therapy, disposable sterile needles will be placed on LI4, ST36, LV3, B22, B23, B24 and B25 of both sides of a patient for 15 minutes. For Chuna therapy, the patient lies on the Ergo Style™ FX-5820 Table in the prone position and back muscles will be relaxed by manual manipulation during flexion and extension movement of the table for 5 to 6 minutes. Patient consultation regarding the precautions for everyday life, the precautions for activity in bed, the precautions for walking, the precautions for particular movements and the exercises will be offered for 5 minutes.
Non-surgical conventional standard treatmentOther
Patients in this arm will be treated with 10 sessions of non-surgical conventional standard treatment including conventional drug treatment and injection treatment under the consultation of neurosurgeons or doctors of anesthesiology or rehabilitation medicine during 5 weeks. For drug therapy, muscle relaxants, NSAIDs, gabapentin, pregabalin or tricyclic antidepressants will be prescribe. For epidural steroid injection, 3cc of epidurals will be injected at the affected lesion once or twice. For physical therapy, participants shall participate in conventional physical therapy with the aid of physical therapists, including heating pad, deep tissue heating device and transcutaneous electrical nerve stimulation (TENS) twice a week during the five weeks of participation.
| Study group | Role | What they receive |
|---|---|---|
| Mokhuri intensive treatment group | Experimental | Patients in this arm will be treated with 35-week of Mokhuri intensive treatment program which compromise 10 sessions of acupuncture, Chuna and patient consultation during 5 weeks. Receives: Other: Mokhuri intensive treatment |
| Non-surgical conventional treatment group | Active comparator | Patients in this arm will be treated with 10 sessions of non-surgical conventional standard treatment including conventional drug treatment and injection treatment during 5 weeks. Receives: Other: Non-surgical conventional standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
0 to 100 Visual Analogue Scale (VAS) for low back pain
The degree of pain recognized as backache is indicated on a 100 mm straight line. The participant is to indicate the average level of lumbar pain experienced for the past one week.
Measured: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Secondary outcomes (10)
0 to 100 Visual Analogue Scale (VAS) for leg pain
The degree of pain recognized as leg pain is indicated on a 100 mm straight line. The participant is to indicate the average level of lumbar pain experienced for the past one week.
Measured: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
EQ-5D
For assessing quality of life, participants must place checkmarks at the most appropriate points in response to inquiries on each of the five items regarding their health conditions.
Measured: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Oswestry Disability Index
ODI is the index derived from the Oswestry disability questionnaire (ODQ) for assessing the degree of pain, sleep disturbance, self-treatment, walking, sitting, standing, moving, sexual life, social activities, and travel.
Measured: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Roland-Morris Disability Questionnaire (RMDQ)
The Roland-Morris Disability Questionnaire (RMDQ) is a tool that is widely used for evaluating the functional conditions of patients with low back pain.
Measured: 2nd, 6th, 7th, 18th, 30th, 54th and 102th weeks
Zurich Claudication Questionnaire (ZCQ)
Zurich Claudication Questionnaire (ZCQ) is an instrument for assessing pain and symptoms related to the spinal stenosis.
Measured: 2nd, 6th, 7th, 18th, 30th, 54th and 102th weeks
Walking duration and distance free of leg pain
Patients walk on the revolving tracks to a distance of 25m at their preferred speed.
Measured: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
The ratio between the actual duration of participation and the originally scheduled duration in each group
Participants whose 0 to 100 VAS for back pain and leg pain would decrease below 10 at every-week evaluation will stop the treatment immediately. The numbers of patients who stop the scheduled treatments early and finished full scheduled treatments will be assessed in each group and the differences in the ratio between groups will be assessed.
Measured: 7th week
Treadmill test
The patients shall walk on the level treadmill at a speed of 1.5 miles (2.414 km/sec). The time until they feel pain in their legs is to be measured.
Measured: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Adverse event assessments
. Participants voluntarily report adverse events and experiments are needed to observe them on a regular basis.
Measured: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Investigation for the presence of any additional spondylolisthesis treatment and the types thereof
Concomitant medication or treatments will be recorded during the follow up period.
Measured: 18th, 30th, 54th and 102th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start15 Dec 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spondylolisthesis, Lumbosacral RegionStudies 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
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kim Ki Ok
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Mayo Clinic, Kyunghee University Medical Center
- Responsible party
- Sponsor-investigator, Kim Ki Ok, Mokhuri Oriental Hospital
- Investigators
- Kiok Kim, Dr., Principal investigator, Mokhuri Oriental Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03107468
- Sponsor's protocol ID
- MHNBH-16031
- Status last verified
- Jan 2021
- First submitted
- 5 Apr 2017
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim K, Yan D, Bauer BA, Choi JC, Wang Z, Jung JE, Kim J, Kim TH, Eldrige JS, Mauck WD, Holmes BD, Bublitz SE, Seo M, Qu W. Nonsurgical Integrative Treatments for Symptomatic Degenerative Lumbar Spondylolisthesis: A Multinational Randomized Controlled Clinical Trial. Mayo Clin Proc. 2026 Jun;101(6):955-962. doi: 10.1016/j.mayocp.2025.05.030. Epub 2025 Nov 2.
PubMed 41176728Kim K, Youn Y, Lee SH, Choi JC, Jung JE, Kim J, Qu W, Eldrige J, Kim TH. The effectiveness and safety of nonsurgical integrative interventions for symptomatic lumbar spinal spondylolisthesis: A randomized controlled multinational, multicenter trial protocol. Medicine (Baltimore). 2018 May;97(19):e0667. doi: 10.1097/MD.0000000000010667.
PubMed 29742708
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Safety of Traditional Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis: a Randomized Controlled International Collaborative Multi-center Trial
- ClinicalTrials.gov ID
- NCT03107468
- Acronym / sponsor ID
- MHNBH-16031
- Conditions
- Spondylolisthesis, Lumbosacral Region
- Keywords
- Non-surgical treatment, Acupuncture, Chuna, Physiotherapy, Epidural steroid injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Kim Ki OkUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute, Mayo Clinic, Kyunghee University Medical Center
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Apr 2017 (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 clinical trial for evaluating the safety and effectiveness of the Mokhuri intensive treatment program regarding pain and function before and after treatment between a group receiving the Mokhuri intensive treatment program (Chuna, acupuncture, and patient education) for five weeks and another group receiving non-surgical conventional standard treatment (drugs for pain relief, epidural steroid injection treatment, and physical therapy).
The trial will be conducted through international cooperation between Mayo Clinic in the United States and Mokhuri Oriental Medicine Hospital in Korea. All subjects in Korea and the US will be selected based on the same inclusion criteria and exclusion criteria. All subjects in the treatment arm will receive the same treatment in Korea and the US. In collaboration and with the support of Mayo Clinic's Department of Integrative Medicine and Health, and to ensure treatment consistency between Korea and the US, an acupuncturist from the USA will travel to Korea and train on-site for one month in Mokhuri hospital.
The trial subjects who agree to participate in the clinical trial after providing informed consent will receive the required examinations and tests according to the clinical trial plan. If they are appropriate for this clinical trial and eligible based on the Inclusion and exclusion criteria, they will be randomly assigned to the group that will undergo the focused Mokhuri intensive treatment program and to the group that will receive non-surgical conventional treatment on their second visit. All the subjects in this study will be educated regarding the study procedure and scheduled visits and will participate in the allocated treatments for five weeks. Afterwards, clinical outcomes of both groups will be evaluated after end of the treatments from between a week and five weeks (within +7 days). The clinical trial ends after the follow-up evaluations that will take place 12 weeks, 24 weeks, 48 weeks, and 96 weeks after the end of the treatment evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mokhuri intensive treatment group | Experimental | Other: Mokhuri intensive treatmentPatients in this arm will be treated with 35-week of Mokhuri intensive treatment program which compromise 10 sessions of acupuncture, Chuna and patient consultation during 5 weeks. |
| Non-surgical conventional treatment group | Active comparator | Other: Non-surgical conventional standard treatmentPatients in this arm will be treated with 10 sessions of non-surgical conventional standard treatment including conventional drug treatment and injection treatment during 5 weeks. |
Who may qualify
- Ages
- 19 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Individuals with all the following requirements will be included as appropriate subjects in the clinical trial:
Key exclusion criteria (15 listed)
- Subjects will be excluded for the following conditions:
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 |
|---|---|---|
| Mokhuri intensive treatmentPatients in this arm will be treated with acupuncture, Chuna and patient consultation during 5 weeks. For acupuncture therapy, disposable sterile needles will be placed on LI4, ST36, LV3, B22, B23, B24 and B25 of both sides of a patient for 15 minutes. For Chuna therapy, the patient lies on the Ergo Style™ FX-5820 Table in the prone position and back muscles will be relaxed by manual manipulation during flexion and extension movement of the table for 5 to 6 minutes. Patient consultation regarding the precautions for everyday life, the precautions for activity in bed, the precautions for walking, the precautions for particular movements and the exercises will be offered for 5 minutes. | Other | Mokhuri intensive treatment group |
| Non-surgical conventional standard treatmentPatients in this arm will be treated with 10 sessions of non-surgical conventional standard treatment including conventional drug treatment and injection treatment under the consultation of neurosurgeons or doctors of anesthesiology or rehabilitation medicine during 5 weeks. For drug therapy, muscle relaxants, NSAIDs, gabapentin, pregabalin or tricyclic antidepressants will be prescribe. For epidural steroid injection, 3cc of epidurals will be injected at the affected lesion once or twice. For physical therapy, participants shall participate in conventional physical therapy with the aid of physical therapists, including heating pad, deep tissue heating device and transcutaneous electrical nerve stimulation (TENS) twice a week during the five weeks of participation. | Other | Non-surgical conventional treatment group |
Primary outcome
0 to 100 Visual Analogue Scale (VAS) for low back pain
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
The degree of pain recognized as backache is indicated on a 100 mm straight line. The participant is to indicate the average level of lumbar pain experienced for the past one week.
10 secondary outcomes
0 to 100 Visual Analogue Scale (VAS) for leg pain
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
EQ-5D
Time frame: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Oswestry Disability Index
Time frame: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Roland-Morris Disability Questionnaire (RMDQ)
Time frame: 2nd, 6th, 7th, 18th, 30th, 54th and 102th weeks
Zurich Claudication Questionnaire (ZCQ)
Time frame: 2nd, 6th, 7th, 18th, 30th, 54th and 102th weeks
Walking duration and distance free of leg pain
Time frame: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
The ratio between the actual duration of participation and the originally scheduled duration in each group
Time frame: 7th week
Treadmill test
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Adverse event assessments
Time frame: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Investigation for the presence of any additional spondylolisthesis treatment and the types thereof
Time frame: 18th, 30th, 54th and 102th weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Derived from this study: PubMed 41176728Kim K, Yan D, Bauer BA, Choi JC, Wang Z, Jung JE, Kim J, Kim TH, Eldrige JS, Mauck WD, Holmes BD, Bublitz SE, Seo M, Qu W. Nonsurgical Integrative Treatments for Symptomatic Degenerative Lumbar Spondylolisthesis: A Multinational Randomized Controlled Clinical Trial. Mayo Clin Proc. 2026 Jun;101(6):955-962. doi: 10.1016/j.mayocp.2025.05.030. Epub 2025 Nov 2.
- Derived from this study: PubMed 29742708Kim K, Youn Y, Lee SH, Choi JC, Jung JE, Kim J, Qu W, Eldrige J, Kim TH. The effectiveness and safety of nonsurgical integrative interventions for symptomatic lumbar spinal spondylolisthesis: A randomized controlled multinational, multicenter trial protocol. Medicine (Baltimore). 2018 May;97(19):e0667. doi: 10.1097/MD.0000000000010667.
- Individual participant dataSharing planned: No
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.
Kiok Kim, Dr. principal investigator
Mokhuri Oriental Medicine Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mokhuri intensive treatment and Non-surgical conventional standard treatment in people with Spondylolisthesis, Lumbosacral Region, run by Kim Ki Ok at 2 sites in 2 countries.
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 11 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Results are not available in the source record.
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?
0 to 100 Visual Analogue Scale (VAS) for low back pain (time frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03107468, which also lists 2 linked publications.
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 6 Jan 2021.