This is pilot study for a 3-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy, acupunture therapy and physical therapy, medication(prn) for cervical disc herniation.
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture, the type and number of acupuncture and the type and time of physical therapy according to participants' conditions, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
84
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 number of acupuncture therapy 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. According to clinical judgment, clinicians can prescribe analgesics and muscle relaxants if necessary.
Kyung Hee University Korean Medicine Hospital
Seoul, Dongdaemun-gu, South Korea
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, South Korea
Numeric rating scale (NRS) of neck 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, 13, 25
Numeric rating scale (NRS) of radiating arm 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, 13, 25
Visual analogue scale (VAS) of neck pain and radiating arm 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, 13, 25
Neck Disability Index (NDI)
NDI 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, 7, 13, 25
Northwick Park Questionnaire (NPQ)
NPQ measures the neck pain and the consequent patient disabilities. The questionnaire is divided in nine five-part sections. Each parameter is divided in five answer possibilities with points from 0 till 4. 0 is significant for no pain and 4 is significant for worst pain. The maximum score is 36 if all nine questions were answered and 32 if only the first eight questions were answered. The percentage ranges from 0% to 100%. The higher the percentage, the greater the disability and the pain.
Time frame: Week 1, 7, 13, 25
Patient Global Impression of Change (PGIC)
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Dongguk University Bundang Oriental Hospital
Seongnam-si, Gyeonggi-do, South Korea
Haeundae Jaseng Hospital of Korean Medicine
Busan, South Korea
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, South Korea
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.)
Time frame: Week 7, 13, 25
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, 7, 13, 25
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, 7, 13, 25