Korean Medicine for Symptomatic Lumbar Spinal Spondylolisthesis
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 19 - 78 |
| Updated: | 4/13/2017 |
| Start Date: | April 2017 |
| End Date: | December 2020 |
| Contact: | Tae-Hun Kim, Dr. |
| Email: | rockandmineral@gmail.com |
| Phone: | 829589089 |
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.
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.
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
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