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Completed

NCT Number: NCT04833270

Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study

This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.

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Key information

Conditions

Lumbar Disc Prolapse With Radiculopathy

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jaseng Hospital of Korean Medicine

Seoul, 06110, South Korea

About this study

Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and pharmacological treatment group. Participants of each group will receive twice a week for total 8 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific intervention and dosage of pharmacological and non-pharmacological treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days.
  • Onset time of radiating pain occurred within 12 weeks.
  • Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)
  • 19-70 years old
  • participants who agreed and signed informed consent form

Exclusion criteria

  • Spine metastasis of cancer, acute fracture of spine, or spine dislocation
  • Progressive neurologic deficits or severe neurologic deficits
  • Soft tissue diseases that can induce low back pain(ie. cancer, fibromyalgia, rheumatoid arthritis, gout,etc)
  • Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
  • Concurrent use of steroids, immunosuppressants, orpsychotropic medications or any other medication that can interrupt the study result
  • Hemorrhagic disease, severe diabetes or taking anticoagulant drug
  • Participants who took NSAIDs or pharmacopuncture within 1 week
  • Pregnant or lactating women
  • Participants who had undergone lumbar surgery within 3 months
  • Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
  • Participants who can not write informed consent
  • Participants who is difficult to participate in the trial according to investigator's decision

Treatment and study plan

KM non-pharmacological treatment group

Other

This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject.

Pharmacological treatment group

Other

This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject.

Primary outcomes

  1. Numeric rating scale (NRS) of radiating pain in lower extremities

    Time frame: week 9

    NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.

Secondary outcomes

  1. Numeric rating scale (NRS) of radiating pain in lower extremities

    Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27

    NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.

  2. Numeric rating scale (NRS) of low-back pain

    Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27

    NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.

  3. Visual analogue scale (VAS) of leg radiating pain

    Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27

    Visual analogue scale of radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome.

  4. Visual analogue scale (VAS) of low-back pain

    Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27

    Visual analogue scale of radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome.

  5. Oswestry Disability Index (ODI)

    Time frame: week 1, 5, 9, 14, 27

    ODI is a functional disability questionnaire. The possible range of eachitem score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome)

  6. Fear-Avoidance Beliefs Questionnaire (FABQ)

    Time frame: week 1, 9, 14, 27

    FABQ is one of pateint-reported outcome questionnaire which consists of total 16 questions. Through FABQ, the investigator can evaluate fear avoidance responses, especially in physical and occupational activity domain for patients with low-back pain

  7. Patient Global Impression of Change (PGIC)

    Time frame: week 9, 14, 27

    Participants rate the improvement after treatment on a 7-point Likert scale(1, very much improved; 2, much improved; 3, minimally improved; 4, nochange; 5, minimally worse; 6, much worse; or 7, very much worse.)

  8. Short Form-12 Health Survey version 2 (SF-12 v2)

    Time frame: week 1, 5, 9, 14, 27

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

  9. EuroQol-5 Dimension (EQ-5D-5L)

    Time frame: week 1, 5, 9, 14, 27

    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)

Sponsors and collaborators

Lead sponsor

Jaseng Hospital of Korean Medicine

Other

Collaborators

  • Korea Institute of Oriental Medicine

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2021
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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