This is pilot study for a 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy and physical therapy for chronic low back pain.
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture and the type and time of physical therapy according to participants' conditions, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea
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
Visual analogue scale (VAS) of low back pain
Visual analogue scale of low back pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
Time frame: Change from baseline VAS at week 6
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, 10, 16
Numeric rating scale (NRS) of low back pain and leg radiating 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, 10, 16
Oswestry Disability Index (ODI)
ODI is a functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome).
Time frame: Week 1, 6, 10, 16
Korean version of the Roland-Morris Disability Questionnaire (RMDQ)
The Roland Morris Disability Questionnaire consists of 24 statements relating to the person's perceptions of their back pain and associated disability. This includes items on physical ability/activity (15), sleep/rest (3), psychosocial (2), household management (2), eating (1) and pain frequency (1). There is no weighting applied to the statements, therefore the score can range from 0 (no disability) to 24 (maximal disability).
Time frame: Week 1, 6, 10, 16
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, no change; 5, minimally worse; 6, much worse; or 7, very much worse.)
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Time frame: Week 6, 10, 16
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, 6, 10, 16
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, 6, 10, 16