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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Age 19 to 78 years.
  • 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.
  • Suffering from neurologic claudication or radicular pain at least for one year.
  • Those with neurogenic claudication within five minutes when walking on a treadmill at the speed of 1.5 miles per hour.
  • Not receiving epidural injection treatments within the past one month.
  • Those who have not undergone lumbar surgery
  • Confirmed spondylolisthesis on L-spine AP, lateral & both oblique views.
  • 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:
    • Those with a history of diseases in the past or in the present that cause ambulatory functional disability;
    • Knee joint and hip joint disorders that severely limit walking (i.e., moderate or severe osteoarthritis in the knee or hip joints);
    • 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;
    • Severe diseases (cardiac disorders or renal insufficiency) such that the ambulatory evaluation is not attainable;
    • Other specific spinal diseases (ankylosing spondylitis, spinal osteomyelitis, metabolic diseases, severe osteoporosis, etc.);
    • Severe neurological defects including foot drop or cauda equina syndrome;
    • Spinal instability confirmed by L-spine x-ray flexion and extension views;
    • Those with malignancy;
    • 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);
    • Using narcotic analgesics, including the external dosage form or patch;
    • On medications for respiratory diseases including gastritis, stomach ulcer, and irritable bowel syndrome;
    • Pregnant women, lactating women, or those planning to become pregnant;
    • Those who appear likely to encounter difficulties in adhering to this protocol such as those regarding treatment, hospitalization, or preparation for the survey;
    • Subjects who the clinical investigators judge to be inappropriate.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

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

Cerrado para la inscripción

Contact information:

Seyedeh Sharare Dehghani M.D.

(507) 538-8444

dehghani.seyedehsharare@mayo.edu

More information

Publicaciones

Publications are currently not available
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CLS-20305348

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