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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Tae-Hun Kim, Dr.||firstname.lastname@example.org|
|United States, Minnesota|
|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 email@example.com|
|Principal Investigator:||Kiok Kim, Dr.||Mokhuri Oriental Medicine Hospital|