Alternative and Integrative Therapy for Lumbar Disk Herniation

November 5, 2018 updated by: Jaseng Hospital of Korean Medicine

The Long-term Course of Patients Undergoing Alternative and Integrative Therapy for Lumbar Disk Herniation: A Prospective Observational Study

The investigators report management of lumbar disc herniation with severe sciatic pain using an integrative complementary and alternative medicine approach with a 5 year follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-896
        • Jaseng Spine and joint Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

integrative hospital that offers both Western and traditional Korean medical services

Description

Inclusion Criteria:

  • LBP with sciatica,
  • A numeral rating scale (NRS) leg pain intensity of 5 or higher
  • Onset within 1 year;
  • Lumbar Disk Heriation confirmed by MRI;
  • Written consent to attend 6 months of integrative CAM treatment and following assessment visits.

Exclusion Criteria:

  • Treatment regarding the current LBP and/or sciatica (e.g. surgery, nerve block, or analgesic medication) other than the CAM treatment specified in the protocol
  • Non-spinal or soft tissue problem related to back pain or sciatica (e.g. pregnancy, spinal tumor, or rheumatoid arthritis)
  • History of spinal surgery, vertebral dislocation, fracture, or cancer;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lumbar disc herniation patients
LBP with sciatica, with a numeral rating scale (NRS) leg pain intensity of 5 or higher and onset within 1 year; (2) LDH confirmed by MRI
Other: herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analogue scale for low back and leg pain
Time Frame: Changes from Baseline in Visual analogue scale at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
Changes from Baseline in Visual analogue scale at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
the Oswestry Disability Index
Time Frame: Changes from Baseline in the Oswestry Disability Index at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
Changes from Baseline in the Oswestry Disability Index at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
the SF-36 Health Survey
Time Frame: Changes from Baseline in the SF-36 Health Survey at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
Changes from Baseline in the SF-36 Health Survey at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Straight Leg Raise test
Time Frame: Changes from Baseline in the Straight Leg Raise test at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
Changes from Baseline in the Straight Leg Raise test at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
Adverse events
Time Frame: at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.

Skin and general reactions, aggravation or change in pain before and after acupuncture, pharmacoacupuncture, and Chuna manipulation treatment were observed.

Regular blood tests (blood cell count, liver, renal function tests, inflammatory activity indexes) were administered.
at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaseng Hospital of Korean Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2006

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

November 4, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (ESTIMATE)

November 21, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-CT-2011-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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