Back to resultsKorean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis
Primary Purpose
Spondylolisthesis, Lumbosacral Region
Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Mokhuri intensive treatment
Non-surgical conventional standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Spondylolisthesis, Lumbosacral Region focused on measuring Non-surgical treatment, Acupuncture, Chuna, Physiotherapy, Epidural steroid injection
Eligibility Criteria
Inclusion Criteria:
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
- 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.
Exclusion Criteria:
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.)
- 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
Sites / Locations
- Mayo Clinic
- Mokhuri Oriental Medicine Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mokhuri intensive treatment group
Non-surgical conventional treatment group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Zurich Claudication Questionnaire (ZCQ)
Zurich Claudication Questionnaire (ZCQ) is an instrument for assessing pain and symptoms related to the spinal stenosis.
Walking duration and distance free of leg pain
Patients walk on the revolving tracks to a distance of 25m at their preferred speed.
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.
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.
Adverse event assessments
. Participants voluntarily report adverse events and experiments are needed to observe them on a regular basis.
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.
Full Information
NCT ID
NCT03107468
First Posted
April 5, 2017
Last Updated
January 4, 2021
Sponsor
Kim Ki Ok
Collaborators
Korea Health Industry Development Institute, Mayo Clinic, Kyunghee University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03107468
Brief Title
Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis
Official Title
The Effectiveness and Safety of Traditional Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis: a Randomized Controlled International Collaborative Multi-center Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kim Ki Ok
Collaborators
Korea Health Industry Development Institute, Mayo Clinic, Kyunghee University Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylolisthesis, Lumbosacral Region
Keywords
Non-surgical treatment, Acupuncture, Chuna, Physiotherapy, Epidural steroid injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Independent outcome assessors who do not know allocation result will participate in the outcome assessment.
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mokhuri intensive treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-surgical conventional treatment group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Mokhuri intensive treatment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-surgical conventional standard treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
0 to 100 Visual Analogue Scale (VAS) for low back pain
Description
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.
Time Frame
1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Secondary Outcome Measure Information:
Title
0 to 100 Visual Analogue Scale (VAS) for leg pain
Description
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.
Time Frame
1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Title
EQ-5D
Description
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.
Time Frame
2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Title
Oswestry Disability Index
Description
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.
Time Frame
2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Title
Roland-Morris Disability Questionnaire (RMDQ)
Description
The Roland-Morris Disability Questionnaire (RMDQ) is a tool that is widely used for evaluating the functional conditions of patients with low back pain.
Time Frame
2nd, 6th, 7th, 18th, 30th, 54th and 102th weeks
Title
Zurich Claudication Questionnaire (ZCQ)
Description
Zurich Claudication Questionnaire (ZCQ) is an instrument for assessing pain and symptoms related to the spinal stenosis.
Time Frame
2nd, 6th, 7th, 18th, 30th, 54th and 102th weeks
Title
Walking duration and distance free of leg pain
Description
Patients walk on the revolving tracks to a distance of 25m at their preferred speed.
Time Frame
2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Title
The ratio between the actual duration of participation and the originally scheduled duration in each group
Description
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.
Time Frame
7th week
Title
Treadmill test
Description
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.
Time Frame
1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Title
Adverse event assessments
Description
. Participants voluntarily report adverse events and experiments are needed to observe them on a regular basis.
Time Frame
2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
Title
Investigation for the presence of any additional spondylolisthesis treatment and the types thereof
Description
Concomitant medication or treatments will be recorded during the follow up period.
Time Frame
18th, 30th, 54th and 102th weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
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.)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiok Kim, Dr.
Organizational Affiliation
Mokhuri Oriental Medicine Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mokhuri Oriental Medicine Hospital
City
Seoul
ZIP/Postal Code
06272
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29742708
Citation
Kim 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.
Results Reference
derived
Learn more about this trial
Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis
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