Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation

October 17, 2023 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation

Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Cervical Disc Herniation With Radiculopathy

A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in cervical disc herniation patients with neck pain or cervical radiculopathy at 4 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, work loss and quality of life patient-reported outcomes

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational study to the aim of investigating the effectiveness and safety of integrative Korean medicine treatment (generally consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) in cervical disc herniation patients with neck pain or cervical radiculitis diagnosed by cervical MRI and clinical symptoms including cervical radiculopathy at 4 locations of Jaseng Hospital of Korean Medicine (Gangnam, Bucheon, Daejeon, Haeundae) as assessed through of pain, functional disability, work loss, and quality of life patient-reported outcomes with a 5-year follow-up period

Study Type

Observational

Enrollment (Actual)

120

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

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

17 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with symptoms of neck pain or radiating arm pain alongside cervical radiculopathy symptoms

Description

Inclusion Criteria:

  • Patients with age between 19 years ~ 65 years
  • Patients with one arm pain or both side arm pain or neck pain with intensity of NRS ≥6 which occurred less then 12 month before
  • Patients with cervical radiculopathy symptoms of one or both side of arms
  • Patients diagnosed with cervical disc herniation with over protrusion degree of prolapsed inter-vertebral disc assessed on MRI
  • Patients with plans of receiving Korean medicine treatment for cervical disc herniation for ≥2 months
  • Patients who have agreed to study participation

Exclusion Criteria:

  • Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
  • Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause neck pain or radiating arm pain (e.g. spinal tumor, rheumatoid arthritis)
  • Patients with medical history of cervical myelopathy which can cause neck pain or radiating arm pain
  • Patients with medical history of surgery in relation with cervical disc herniation
  • Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anticoagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)
  • Pregnant patients or patients planning pregnancy
  • Patients with serious psychological disorders
  • Patients unable to fill out study participation consent form
  • Patients deemed unsuitable for study participation as assessed by the researchers

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: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numeric rating scale (NRS) out of neck pain and radiating arm pain
Time Frame: Time Frame: Change from baseline to 4 months
Change from higher score at baseline out of neck pain or radiating arm pain intensity to same score at 4 months. Total score range: -10 (worse outcome) to 10 (better outcome) Total score range: -10 (worse outcome) to 10 (better outcome)
Time Frame: Change from baseline to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS) of neck pain
Time Frame: Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Neck pain intensity for the past 3 days. Total score range: 0 (better outcome) to 100 (worse outcome)
Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Visual analogue scale (VAS) of radiating arm pain
Time Frame: Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Radiating arm pain intensity for the past 3 days. Total score range: 0 (better outcome) to 100 (worse outcome)
Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Neck Disability Index (NDI)
Time Frame: Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 50 (worse outcome)
Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Patient Global Impression of Change (PGIC)
Time Frame: Time Frame: 8, 16, 20, 24 weeks, 1, 3, 5 years
Global patient-reported outcome. Total score range: 1 (better outcome) to 7 (worse outcome)
Time Frame: 8, 16, 20, 24 weeks, 1, 3, 5 years
EuroQol 5-dimensions 5-levels (EQ-5D-5L)
Time Frame: Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Health-related quality of life questionnaire. Total score range: 11111 (better outcome) to 55555 (worse outcome)
Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Type and frequency of other intervention(s)
Time Frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Use of any other additional intervention(s) other than the integrative Korean medicine treatment administered by the attending physician (start date of treatment, end date of treatment, name of treatment, number of treatment sessions received, and other comments)
Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Physical examination
Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Cervical physical examination
Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Type and frequency of adverse reaction(s)
Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Safety
Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Numeric rating scale (NRS) of Neck pain
Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Neck pain intensity for the past 3 days. Total score range: 0 (better outcome) to 10 (worse outcome)
Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Numeric rating scale (NRS) of radiating arm pain
Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Radiating arm pain intensity for the past 3 days. Total score range: 0 (better outcome) to 10 (worse outcome)
Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
SF-36
Time Frame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
EQ-VAS
Time Frame: [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]
The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
[Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]

Collaborators and Investigators

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

Sponsor

Jaseng Medical Foundation

Investigators

  • Principal Investigator: Won-Il Ko, KMD, Jaseng Hospital of Korean Medicine
  • Principal Investigator: Sun-A Kim, KMD, Daejeon Jaseng Hospital of Korean Medicine
  • Principal Investigator: Hyun-Woo Cho, KMD, Haeundae Jaseng Hospital of Korean Medicine
  • Principal Investigator: Ji-Yun Seo, KMD, Bucheon 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)

June 24, 2019

Primary Completion (Actual)

January 28, 2022

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-CT-2019-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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