이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

비급성 요추 추간판 탈출증의 비약물적 치료와 약물적 치료 비교

2026년 9월 16일 업데이트: Jaseng Medical Foundation

비급성 요추 추간판 탈출증에 대한 비약물적 치료와 약물적 치료의 비교 효과: 다기관, 실용적 무작위 대조, 병렬 그룹 연구

This is a randomized controlled study comparing non-pharmacological treatment to proactive pharmacological treatment for patient with non-acute lumbar disc herniation with moderate or higher levels of pain. The study involves 200 adult patients aged 19-69, with 50 patients from each participating hospital. Patients will be randomly assigned to either the non-pharmacological treatment group or the pharmacological treatment group 1:1 ratio. Specific interventions will be determined by doctors and Korean medicine doctors without predefined treatment strategies. The non-pharmacological treatment include acupuncture, electroacupuncture, spinal manual therapy and motion style acupuncture. The pharmacological treatment include medication prescription, injection, and nerve block. Treatment period is 8 weeks, and f/u for 3 years.

연구 개요

상세 설명

This is a pragmatic, multi-centered, randomized controlled, parallel-grouped study aiming to compare the effectiveness of a non-pharmacological treatment strategy and a active pharmacological treatment strategy in managing non-acute lumbar disc herniation with moderate or higher levels of pain persisting for more than one month in adult men and women aged 19 to 69 years.

The study will include 200 patients with lumbar disc herniation, with 50 patients from each of the participating hospitals (Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Haeundae Jaseng Hospital of Korean Medicine, competitively recruited). The patients will be assigned in a 1:1 ratio to receive either non-pharmacological treatment (100 patients) or active pharmacological treatment (100 patients) in a pragmatic randomized controlled design. The specific interventions for each group will be determined based on clinical judgment by the doctors and Korean medicine doctors involved in the study, without predefining the treatment strategies. The treatment methods, including acupuncture, electroacupuncture, spinal maunal therapy and motion style acupuncture, will be recorded in the case report form for comparative analysis.

For the non-pharmacological treatment group, patients will be recommended to receive non-pharmacological treatment based on TKM. The frequency and specifics of the treatment will be determined by the clinical judgment of the doctors and Korean medicine doctors based on the patient's symptoms, MRI images, and clinical improvement. The treatment will be conducted twice a week for a total of eight weeks, but the frequency may be adjusted according to the patient's condition. Concurrent therapies and adjuvant therapies can be freely chosen by the patients, and the details will be recorded in the case report form.

For the pharmacological treatment group, patients will be educated about proactive pharmacological treatment and recommended to receive pharmacological treatment. The specific pharmacological interventions, such as prescription medication, injection therapy, and nerve block, will be determined by the doctors based on the patient's symptoms, imaging results, and clinical judgment. The details of the prescribed medication, dosage, administration route, and duration will be recorded in the case report form. Similar to the non-pharmacological treatment group, concurrent therapies and adjuvant therapies can be chosen by the patients, and the details will be recorded.

The treatment frequency for the pharmacological treatment group will also be twice a week for a total of eight weeks, with adjustments based on the patient's condition. The effectiveness of the treatment strategies will be assessed through weekly evaluations of the patients' symptoms and treatment progress.

It should be noted that patients are not obligated to strictly follow the assigned treatment strategy, as this is a study recommending a particular treatment strategy rather than enforcing it as a protocol violation.

연구 유형

중재적

등록 (추정된)

200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

      • Busan, 대한민국
        • 모병
        • Haeundae Jaseng Hospital of Korean Medicine
        • 연락하다:
          • Hyun Woo Cho, PhD
        • 연락하다:
      • Daejeon, 대한민국
        • 모병
        • Daejeon Jaseng Hospital of Korean Medicine
        • 연락하다:
    • Gangnam-Gu
      • Seoul, Gangnam-Gu, 대한민국, 135-896
        • 모병
        • Jaseng Hospital of Korean Medicine
        • 연락하다:
    • Gyeonggi-do
      • Bucheon-si, Gyeonggi-do, 대한민국, 14598
        • 모병
        • Bucheon Jaseng Hospital of Korean Medicine
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

19년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • aged 19 to 69 years.
  • lower back pain that has persisted for at least 1 month.
  • a Numeric Rating Scale (NRS) score of 5 or higher for either lower back pain or radiating leg pain over the past three consecutive days.
  • confirmed lumbar disc herniation on MRI that can explain the lower back pain.
  • who have provided written informed consent and agreed to participate in the clinical study.

Exclusion Criteria:

  • diagnosed with specific severe diseases that could be the cause of lower back pain or leg pain (e.g., spinal metastasis, acute fractures, and spinal dislocation).
  • showing progressive neurological deficits or severe neurological symptoms.
  • with pain originating from soft tissue disorders other than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout).
  • with other chronic conditions (e.g., stroke and myocardial infarction, renal disease, diabetic neuropathy, dementia, epilepsy) that may interfere with the treatment effect or result interpretation.
  • taking steroids, immunosuppressive drugs, psychiatric medications, or other medications that may impact the study results.
  • acupuncture or nerve block treatment is inappropriate or unsafe, such as those with a history of bleeding disorders, receiving anticoagulant therapy, or diagnosed with uncontrolled diabetes.
  • taken non-steroidal anti-inflammatory drugs (NSAIDs) or other pain-affecting drugs or received acupuncture treatment within the past 5 days.
  • Pregnant women, those planning pregnancy, or breastfeeding women.
  • within 3 months after lumbar surgery.
  • who have not completed participation in another clinical study within the past month or have plans to participate in another clinical study within 6 months from the selection date or during the study participation and follow-up period.

Inability to provide written informed consent.

- Other cases where the researchers determine that participation in the clinical study would be difficult.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Non-pharmacological treatment strategy

Interventions: Non-pharmacological treatment include acupuncture, electroacupuncture, spinal manual therapy, and motion style acupuncture treatment.

Frequency: Not specified (Twice a week recommended) Duration: Eight weeks.

Acupuncture, elctroacupuncture, spinal manual therapy, motion style acupucnture treatment

활성 비교기: Pharmacological treatment strategy

Interventions: Active pharmacological treatment involving prescription medication, injection therapy, or other pharmacological interventions.

Frequency: Not specified (Twice a week recommended) Duration: Eight weeks.

Prescription medication, injection therapy, nerve blocks, or other pharmacological interventions commonly used for managing lumbar disc herniation.

This group is treated using the above treatment strategies, and no drug is specified.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Oswestry Disability Index (ODI)
기간: Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36

The Oswestry Disability Index (ODI) is a questionnaire used to assess the functional status and degree of disability caused by lower back pain. It consists of 10 items that evaluate various aspects of daily activities and mobility. Each item is rated on a 6-point scale, with higher scores indicating a greater level of disability.

From 0 to 100. Higher scores mean a worse outcome.

Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
Numeric Rating Scale for Pain of Dominant Change (NRS for DC)
기간: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36

The study will evaluate the intensity of lower back pain and radiating leg pain using the Numeric Rating Scale (NRS). Patients will rate their pain levels on a scale from 0 to 10, where 0 represents no pain and 10 represents the most severe imaginable pain. The NRS for Dominant Change (NRS-DC) will be calculated as the higher value between the change in NRS scores from baseline for lower back pain and radiating leg pain. The NRS-DC will serve as a key evaluation indicator for pain intensity.

Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36

2차 결과 측정

결과 측정
측정값 설명
기간
Recurrence
기간: Week 13, 26, 39, 52, Month 18, 24, 36

This study will confirm the recurrence of symptoms in patients through a yes or no response.

Week 13, 26, 39, 52, Month 18, 24, 36
Numeric Rating Scale (NRS) for Low Back Pain
기간: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36

NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participants are asked to report their low back pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable.

Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36
Patient Global Impression of Change (PGIC)
기간: Week 9, 13, 26, 39, 52, Month 18, 24, 36

Participants rate the improvement after treatment on a 7-point Likert scale (1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)

Week 9, 13, 26, 39, 52, Month 18, 24, 36
Fear-Avoidance Beliefs Questionnaire (FABQ)
기간: Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36

The fear-avoidance belief questionnaire (FABQ) is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.

Minimum 0 to maximum 66 scores. Higher score means a worse outcome.

Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
Short Form-12 Health Survey version 2 (SF-12 v2)
기간: Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36

The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.

Ranging from 0 to 100, higher score means a better outcome.

Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
EuroQol-5 Dimension (EQ-5D-5L)
기간: Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36

The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) Ranging from 0 to 1, higher score means a better outcome.

Week 1, 5, 9, 13, 26, 39, 52, Month 18, 24, 36
Credibility and Expectancy
기간: Baseline

The study will measure the level of trust and expectation regarding the effectiveness of the treatment through two questions:

On a scale from 0 to 10, how much do you believe that traditional herbal medicine treatment will alleviate your symptoms? On a scale from 0 to 10, how much do you believe that drug therapy will alleviate your symptoms? 0 indicates no belief or expectation, and 10 indicates full belief and high expectation.

Baseline
Intention to Treat
기간: Week 9

Evaluate participants' intentions if they are willing to receive non-pharmacological treatment strategies or pharmacological treatment strategies in the future on a scale from 0 to 9. 0 indicates no intention, and 10 indicates full belief and high intention.

Week 9
Work Productivity and Activity Impairment-Specific Health Problem
기간: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36

Productivity loss will be assesed by WPAI-SHP. Through the WPAI questionnaire, the overall work productivity, which is a concept combining absenteesim and presenteeism, as well as employment will be investigated and used as outcomes.

Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36
Classification of Disc Degeneration
기간: Week 1, 26, 52, Month 24, 36

Classify the degree of disc degeneration based on the Pfirrmann grading system.

Week 1, 26, 52, Month 24, 36
Stages to a Disc Herniation
기간: Week 1, 26, 52, Month 24, 36

Classify the stage of disc herniation as bulging, protrusion, extrusion, or sequestration/migration.

Week 1, 26, 52, Month 24, 36
Herniated Disc Areas
기간: Week 1, 26, 52, Month 24, 36

Measure the area of the most significant transverse plane slice of the herniated disc on MRI.

Week 1, 26, 52, Month 24, 36
Cost Data Survey
기간: Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36

Measure various cost items related to the treatment, including medical costs, non-medical costs, time costs, and productivity loss costs.

Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 13, 26, 39, 52, Month 18, 24, 36

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 책임자: In-Hyuk Ha, Dr, Jaseng Medical Foundation

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 8월 9일

기본 완료 (추정된)

2030년 12월 31일

연구 완료 (추정된)

2030년 12월 31일

연구 등록 날짜

최초 제출

2023년 7월 20일

QC 기준을 충족하는 최초 제출

2023년 8월 29일

처음 게시됨 (실제)

2023년 9월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 16일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다