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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
115
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.
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.
Mayo Clinic
Rochester, Minnesota, United States
Mokhuri Oriental Medicine Hospital
Seoul, South Korea
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.
Time frame: 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 18th, 30th, 54th and 102th weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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
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.
Time frame: 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.
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
Concomitant medication or treatments will be recorded during the follow up period.
Time frame: 18th, 30th, 54th and 102th weeks
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