This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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.
Jaseng Hospital of Korean Medicine
Seoul, South Korea
Numeric rating scale (NRS) of radiating pain in lower extremities
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'.
Time frame: week 9
Numeric rating scale (NRS) of radiating pain in lower extremities
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'.
Time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 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 awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 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 leg radiating pain
Visual analogue scale of 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
Visual analogue scale (VAS) of low-back pain
Visual analogue scale of 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
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)
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Time frame: week 1, 5, 9, 14, 27
Fear-Avoidance Beliefs Questionnaire (FABQ)
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
Time frame: week 1, 9, 14, 27
Patient Global Impression of Change (PGIC)
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.)
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
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