Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study
Study Details
Study Description
Brief Summary
This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: KM non-pharmacological treatment group Non-pharmacological treatment including Korean medicine will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form. |
Other: KM non-pharmacological treatment group
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.
|
| Active Comparator: Pharmacological treatment group Pharmacological treatment will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form. |
Other: Pharmacological treatment group
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.
|
Outcome Measures
Primary Outcome Measures
- Numeric rating scale (NRS) of radiating pain in lower extremities [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 Outcome Measures
- Numeric rating scale (NRS) of radiating pain in lower extremities [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'.
- Numeric rating scale (NRS) of low-back pain [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'.
- Visual analogue scale (VAS) of leg radiating pain [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.
- Visual analogue scale (VAS) of low-back pain [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.
- Oswestry Disability Index (ODI) [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)
- Fear-Avoidance Beliefs Questionnaire (FABQ) [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
- Patient Global Impression of Change (PGIC) [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.)
- Short Form-12 Health Survey version 2 (SF-12 v2) [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.
- EuroQol-5 Dimension (EQ-5D-5L) [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days.
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Onset time of radiating pain occurred within 12 weeks.
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Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)
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19-70 years old
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participants who agreed and signed informed consent form
Exclusion Criteria:
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Spine metastasis of cancer, acute fracture of spine, or spine dislocation
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Progressive neurologic deficits or severe neurologic deficits
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Soft tissue diseases that can induce low back pain(ie. cancer, fibromyalgia, rheumatoid arthritis, gout,etc)
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Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
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Concurrent use of steroids, immunosuppressants, orpsychotropic medications or any other medication that can interrupt the study result
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Hemorrhagic disease, severe diabetes or taking anticoagulant drug
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Participants who took NSAIDs or pharmacopuncture within 1 week
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Pregnant or lactating women
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Participants who had undergone lumbar surgery within 3 months
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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
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Participants who can not write informed consent
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Participants who is difficult to participate in the trial according to investigator's decision
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jaseng Hospital of Korean Medicine | Seoul | Korea, Republic of | 06110 |
Sponsors and Collaborators
- Jaseng Hospital of Korean Medicine
- Korea Institute of Oriental Medicine
Investigators
- Principal Investigator: Kyoung Sun Park, KMD,Ph.D, Jaseng Hospital of Korean Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JS-CT-2021-01