This study is a 2-armed parallel, multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation.
This study is a multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation. The participants who voluntarily signed informed consent will be randomly assigned in 1:2 ratio to non-pharmacological group and pharmacological group and will receive the 8 weeks of intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
36
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.
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.
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, South Korea
Haeundae Jaseng Hospital of Korean Medicine
Busan, South Korea
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, South Korea
Jaseng Hospital of Korean Medicine
Seoul, South Korea
Oswestry disability index (ODI)
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)
Time frame: week 1, 5, 9, 14, 27
Numeric rating scale (NRS) of low back pain
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Visual analogue scale (VAS) of low back pain and radiating pain in lower extermities
Visual analogue scale of low back pain and radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome.
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Numeric rating scale (NRS) of radiating pain in lower extremities
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Time frame: week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Patient global impression of change (PGIC)
Participants rate the global impression of improvement after treatment on a 7-point Likert scale.
Time frame: week 9, 14, 27
Short form-12 health survey version 2 (SF-12 v2)
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Time frame: week 1, 5, 9, 14, 27
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EuroQol-5 Dimension (EQ-5D-5L)
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)
Time frame: week 1, 5, 9, 14, 27
Credibility and Expectancy
To evaluate participants' expectations for treatment, the nine-point scale(Likert scale) is used to evaluate them. During the screening visit, the candidates will choose their scores in response to the question, "How much do you think non-drug therapy, including Korean medical treatment, or medication will relieve your symptoms?" (1 = not at all, 5 = somewhat, and 9 = very much)
Time frame: week -1
Evaluation question
Use a questionnaire that measures official unofficial medical expenses, non-medical expenses, time costs, and productivity loss costs developed separately to measure cost items. Informal medical expenses, such as purchasing pars or medical devices, include transportation, patient time, transportation, patient time, and nursing costs are non-medical expenses. Productivity loss costs refer to the cost of economic loss caused by the disease itself or by the inability to participate in labor due to premature death from the disease. To calculate the cost of productivity loss, we will use the Work Productivity and Activity Impairment questionnair (WPAI) to convert it into cost-effectiveness analysis.
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Drug Consumption
The type and dose of prescribed drugs or relief drugs due to the active history of drugs taken during the study period are observed through a questionnaire when visiting the study subjects. Other than the medication you are taking, physical therapy, injection therapy, etc. should be recorded in the number of times.
Time frame: week -1, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Adverse events
Safety will be verified by comparing the occurrence of adverse events between the two groups. The researcher evaluates each treatment method and its adverse events on a six-step scale according to the WHO-UMC UMC causality assessment system (1=definitive linked, 2=provocatively linked, 4=probably not related, 5=definitive not related, 5=definitive not related to the study), and all adverse events are classified into three stages by the Spilker taxonomy (Mild(1)): If treatment is not required and does not significantly impair the normal life function, Moderate(2): may significantly impair normal life function, and may require treatment, and Severe(3): severe adverse events require high treatment, and side effects remain.
Time frame: week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27