Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03107468
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 19, 2019
Sponsor:
Collaborators:
Korea Health Industry Development Institute
Mayo Clinic
Kyunghee University Medical Center
Information provided by (Responsible Party):
Kim Ki Ok, Mokhuri Oriental Hospital

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.


Condition or disease Intervention/treatment Phase
Spondylolisthesis, Lumbosacral Region Other: Mokhuri intensive treatment Other: Non-surgical conventional standard treatment Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Independent outcome assessors who do not know allocation result will participate in the outcome assessment.
Primary Purpose: Treatment
Official Title: The Effectiveness and Safety of Traditional Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis: a Randomized Controlled International Collaborative Multi-center Trial
Actual Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Mokhuri intensive treatment group
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.
Other: Mokhuri intensive treatment
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.

Active Comparator: Non-surgical conventional treatment group
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.
Other: Non-surgical conventional standard treatment
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. EQ-5D [ Time Frame: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks ]
    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.

  3. Oswestry Disability Index [ Time Frame: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks ]
    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.

  4. Roland-Morris Disability Questionnaire (RMDQ) [ Time Frame: 2nd, 6th, 7th, 18th, 30th, 54th and 102th weeks ]
    The Roland-Morris Disability Questionnaire (RMDQ) is a tool that is widely used for evaluating the functional conditions of patients with low back pain.

  5. Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 2nd, 6th, 7th, 18th, 30th, 54th and 102th weeks ]
    Zurich Claudication Questionnaire (ZCQ) is an instrument for assessing pain and symptoms related to the spinal stenosis.

  6. Walking duration and distance free of leg pain [ Time Frame: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks ]
    Patients walk on the revolving tracks to a distance of 25m at their preferred speed.

  7. The ratio between the actual duration of participation and the originally scheduled duration in each group [ Time Frame: 7th week ]
    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.

  8. Treadmill test [ Time Frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks ]
    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.

  9. Adverse event assessments [ Time Frame: 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks ]
    . Participants voluntarily report adverse events and experiments are needed to observe them on a regular basis.

  10. Investigation for the presence of any additional spondylolisthesis treatment and the types thereof [ Time Frame: 18th, 30th, 54th and 102th weeks ]
    Concomitant medication or treatments will be recorded during the follow up period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals with all the following requirements will be included as appropriate subjects in the clinical trial:

    1. Those aged from 19 to 78 years
    2. 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
    3. Those suffering from neurologic claudication or radicular pain at least for one year
    4. Those with neurogenic claudication within five minutes when walking on a treadmill at the speed of 1.5 miles per hour
    5. Those not receiving epidural injection treatments within the past one month
    6. Those who have not undergone lumbar surgery
    7. Those who confirmed spondylolisthesis on L-spine AP, lateral & both oblique views
    8. Those who weigh 250 lbs (113.398 kg) or less
    9. Those who are 2.1 m (6.890 ft) in height or shorter
    10. 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:

    1. Those with a history of diseases in the past or in the present that cause ambulatory functional disability
    2. Those with knee joint and hip joint disorders that severely limit walking (i.e. moderate or severe osteoarthritis in the knee or hip joints)
    3. 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
    4. Those with severe diseases (cardiac disorders or renal insufficiency) such that the ambulatory evaluation is not attainable
    5. Those with other specific spinal diseases (ankylosing spondylitis, spinal osteomyelitis, metabolic diseases, severe osteoporosis, etc.)
    6. Those with severe neurological defects including foot drop or cauda equina syndrome
    7. 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.
    8. Those with malignancy
    9. 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)
    10. Those using narcotic analgesics, including the external dosage form or patch
    11. Those on medications for respiratory diseases including gastritis, stomach ulcer, and irritable bowel syndrome
    12. Pregnant women, lactating women, or those planning to become pregnant
    13. Those who appear likely to encounter difficulties in adhering to this protocol such as those regarding treatment, hospitalization, or preparation for the survey
    14. Those subjects who the clinical investigators judge to be inappropriate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107468


Contacts
Layout table for location contacts
Contact: Tae-Hun Kim, Dr. 829589089 rockandmineral@gmail.com

Locations
Layout table for location information
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Wenchun Qu, Dr.       Qu.Wenchun@mayo.edu   
Contact: Zachary Pohlkamp    (507) 293-7466    Pohlkamp.Zachary@mayo.edu   
Korea, Republic of
Mokhuri Oriental Medicine Hospital Recruiting
Seoul, Korea, Republic of, 06272
Contact: Kiok Kim, Dr.    825260880    jsh17342000@daum.net   
Sponsors and Collaborators
Kim Ki Ok
Korea Health Industry Development Institute
Mayo Clinic
Kyunghee University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Kiok Kim, Dr. Mokhuri Oriental Medicine Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kim Ki Ok, President, Mokhuri Oriental Hospital
ClinicalTrials.gov Identifier: NCT03107468     History of Changes
Other Study ID Numbers: MHNBH-16031
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kim Ki Ok, Mokhuri Oriental Hospital:
Non-surgical treatment
Acupuncture
Chuna
Physiotherapy
Epidural steroid injection

Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylolisthesis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases