A Study of Traditional Korean Medicine Effectiveness in Comparison to Non-Surgical Conventional Standard Treatment for Patients with Lumbar Spinal Spondylolisthesis

Overview

About this study

This research is being done, in a joint-effort between Mayo Clinic and the Mokhuri Oriental Medical Hospital, to evaluate the effectiveness and safety of two different types of non-surgical treatment in patients with symptomatic lumbar spinal spondylolisthesis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Age 19 to 78 years
  2. 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. 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. Not receiving epidural injection treatments within the past one month
  6. Those who have not undergone lumbar surgery
  7. Confirmed spondylolisthesis on L-spine AP, lateral & both oblique views
  8. 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:

  1. 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. Knee joint and hip joint disorders that severely limit walking (i.e. moderate or severe osteoarthritis in the knee or hip joints)
    3. 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. Severe diseases (cardiac disorders or renal insufficiency) such that the ambulatory evaluation is not attainable
    5. Other specific spinal diseases (ankylosing spondylitis, spinal osteomyelitis, metabolic diseases, severe osteoporosis, etc.)
    6. Severe neurological defects including foot drop or cauda equina syndrome
    7. Spinal instability confirmed by L-spine x-ray flexion and extension views
    8. Those with malignancy
    9. 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. Using narcotic analgesics, including the external dosage form or patch
    11. 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. Subjects who the clinical investigators judge to be inappropriate

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wenchun Qu, M.D., Ph.D.

Open for enrollment

Contact information:

Dan Yan B.S.

(507)293-7466

Yan.Dan@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20305348

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