Disc Resorption in Lumbar and Cervical Disc Herniation Patients Receiving Integrative Korean Medicine Treatment

July 22, 2022 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation

Evaluation of Disc Resorption in Lumbar and Cervical Intervertebral Disc Herniation Patients Receiving Integrative Korean Medicine Treatment

Measurement of herniated disc resorption and assessment of satisfaction regarding post-treatment state and integrative Korean medicine treatment through phone interview in 500 patients with MRI follow-up results receiving treatment for lumbar and cervical disc herniation at Jaseng Hospital of Korean Medicine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intervertebral disc herniation treatment can be largely divided into conservative and surgical approaches, and the greater majority of patients show relief of symptoms and resorption of herniated disc through non-surgical, conservative management. Despite concerns that early surgical interventions in intervertebral disc herniation without allowing for sufficient conservative treatment may indicate overtreatment, awareness and understanding in the general public is found somewhat lacking.

The objective of this study is to measure herniated disc resorption and assess satisfaction regarding post-treatment state and integrative Korean medicine treatment through phone interview in 500 patients with MRI follow-up results before and after receiving conservative treatment for lumbar and cervical disc herniation at Jaseng Hospital of Korean Medicine.

Study Type

Observational

Enrollment (Actual)

505

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
    • Gyeonggi Province
      • Bucheon, Gyeonggi Province, Korea, Republic of, 14598
        • Jaseng Medical Foundation

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Lumbar and/or cervical disc herniation patients with MRI results before and after receiving treatment at Jaseng Hospital of Korean Medicine between February 2012 and December 2015

Description

Inclusion Criteria:

  • Lumbar and/or cervical disc herniation patients with baseline MRI and follow-up results after receiving treatment at Jaseng Hospital of Korean Medicine visiting between February 2012 and December 2015.
  • Participants giving informed written consent to use of medical records for academic means.

Exclusion Criteria:

  • Participants refusing to participate in study or to respond to phone interview.

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lumbar/cervical disc herniation group
Lumbar and cervical intervertebral disc herniation patients are administered integrative Korean medicine treatment consisting of herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, and Chuna manipulation.
Drug: Herbal medicine
Herbal medicine was administered 2-3 times daily in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
Other Names:
  • Traditional herbal medicine
Procedure: Acupuncture
Acupuncture treatment was administered 1-2 times daily using mainly proximal acupuncture points and Ah-shi points.
Procedure: Pharmacopuncture
Select herbal ingredients (Eucommia ulmoides cortex, Acanthopanax sessiliflorum cortex, Achyranthis bidentata radix, Saposhnikovia divaricata radix, Cibotium barometz rhizoma, Paeonia albiflora radix alba, Ostericum koreanum radix, Angelica pubescens radix, and Scolopendra subspinipes corpus (Paeonia albiflora twice the proportion of that of other ingredients)) were freeze dried into powder form after decoction, then diluted in water-for-injection and adjusted for acidity and pH. Pharmacopuncture was administered once daily at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
Procedure: Bee venom pharmacopuncture
Bee venom pharmacopuncture was administered only after confirming a negative response to hypersensitivity skin tests. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens was injected at 4-5 acupoints proximal to the painful site at the physician's discretion. Each acupuncture point was injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
Other Names:
  • Bee venom acupuncture
Procedure: Chuna manipulation
Chuna is a Korean version of spinal manipulation that incorporates spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation was administered 3-5 times a week to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
Other Names:
  • Chuna spinal manipulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view
Time Frame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Comparison of disc herniation in MRI between the baseline and post-treatment.
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of disc degeneration at disc level most relevant to patient symptoms on MR sagittal and axial view
Time Frame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Level of disc degeneration at disc level most relevant to patient symptoms on MR sagittal and axial view will be classified into 5 levels according to the method suggested by Pfirrmann et al.
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Level of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view
Time Frame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Level of disc herniation at disc level most relevant to patient symptoms on MR sagittal and axial view will be divided into 4 levels: protrusion, extrusion, sequestration, and migration
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Level of herniated disc migration in patients with disc migration at disc level most relevant to patient symptoms on MR sagittal and axial view
Time Frame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Level of herniated disc migration in patients with disc migration will be categorized into 3 levels in accordance with the Komori classification
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Modic type change at vertebrae adjacent to disc level most relevant to patient symptoms on MR sagittal and axial view
Time Frame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Modic type change at vertebrae adjacent to disc level most relevant to patient symptoms on MR sagittal and axial view will be classified into Modic types 0, 1, 2, and 3
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Modic type change location with regard to disc level most relevant to patient symptoms on MR sagittal and axial view
Time Frame: Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Location of modic type change at the vertebrae adjacent to the herniated disc is classified by whether it is above, below, neither above nor below, or both above and below the disc level most relevant to patient symptoms on MR sagittal and axial view
Change from baseline MRI (taken before treatment) at post-treatment completion MRI at average of 9 months
Pain NRS at site of chief complaint
Time Frame: Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years
Low back pain NRS or neck pain NRS
Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years
Radiating pain NRS associated with site of chief complaint
Time Frame: Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years
Radiating leg pain NRS or radiating arm pain NRS
Change from baseline MRI (taken before treatment) at post-treatment follow-up phone interview at average of 3 years
Whether or not patient has been recommended for surgery regarding pain at site of chief complaint
Time Frame: Post-treatment follow-up phone interview at average of 3 years
Whether or not patient has been recommended for surgery regarding pain at site of chief complaint will be recorded dichotomously
Post-treatment follow-up phone interview at average of 3 years
Whether or not pain has recurred for 1 month or longer at site of chief complaint
Time Frame: Post-treatment follow-up phone interview at average of 3 years
Whether or not low back pain, radiating leg pain, neck pain or radiating arm pain has recurred at site of chief complaint will be recorded dichotomously
Post-treatment follow-up phone interview at average of 3 years
Type of treatment received, if any, for pain recurrence for 1 month or longer at site of chief complaint
Time Frame: Post-treatment follow-up phone interview at average of 3 years
Type of treatment received, if any, for pain recurrence at site of chief complaint out of Korean medicine treatment, conventional nonsurgical treatment, or surgery will be recorded
Post-treatment follow-up phone interview at average of 3 years
Whether or not patient was aware of possible spontaneous disc resorption at site of chief complaint at onset
Time Frame: Post-treatment follow-up phone interview at average of 3 years
Whether or not patient is aware of possible spontaneous disc resorption at site of chief complaint will be recorded dichotomously
Post-treatment follow-up phone interview at average of 3 years
Type of treatment patient would recommend to others as primary care
Time Frame: Post-treatment follow-up phone interview at average of 3 years
Type of treatment patient would recommend to others out of surgical and nonsurgical treatment will be recorded
Post-treatment follow-up phone interview at average of 3 years
Satisfaction with integrative Korean medicine treatment
Time Frame: Post-treatment follow-up phone interview at average of 3 years
Satisfaction with integrative Korean medicine treatment will be recorded using a 5-point Likert scale: very dissatisfied, dissatisfied, slightly satisfied, satisfied, very satisfied
Post-treatment follow-up phone interview at average of 3 years
Korean medicine treatment method perceived to be most effective
Time Frame: Post-treatment follow-up phone interview at average of 3 years
Korean medicine treatment method perceived to be most effective out of herbal medicine, pharmacopuncture/bee venom pharmacopuncture, acupuncture, and Chuna manipulation will be recorded
Post-treatment follow-up phone interview at average of 3 years

Collaborators and Investigators

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

Sponsor

Jaseng Medical Foundation

Investigators

  • Principal Investigator: Joowon Kim, KMD, M.Sc., Jaseng Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

July 19, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-CT-2016-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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