Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pharmacopunture therapy | Experimental | The physicians will choose the type and volume of pharmacopuncture according to participants' conditions. |
|
| acupuncture therapy | Active Comparator | The physicians will choose the type and number of acupuncture therapy according to participants' conditions. |
|
| physical therapy, medication(prn) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmacopuncture therapy | Procedure | This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | Week 1, 2, 3, 4, 5, 6, 7, 13, 25 |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | Week 1, 2, 3, 4, 5, 6, 7, 13, 25 |
| Visual analogue scale (VAS) of neck pain and radiating arm pain |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| In-Hyuk Ha, Ph.D. | Jaseng Medical Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Korean Medicine Hospital | Seoul | Dongdaemun-gu | 130-701 | South Korea | ||
| Kyung Hee University Korean Medicine Hospital at Gangdong |
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| acupuncture therapy | Procedure | This is a pragmatic RCT, so the physicians will choose the type and number of acupuncture therapy according to participants' conditions. |
|
| physical therapy, medication(prn) | Procedure | 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. |
|
Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome. |
| 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). | 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. | Week 1, 7, 13, 25 |
| 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.) | 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. | 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) | Week 1, 7, 13, 25 |
| Seoul |
| Gangdong-gu |
| 05278 |
| South Korea |
| Jaseng Hospital of Korean Medicine | Seoul | Gangnam-Gu | 135-896 | South Korea |
| Bucheon Jaseng Hospital of Korean Medicine | Bucheon-si | Gyeonggi Province | 14598 | South Korea |
| Dongguk University Bundang Oriental Hospital | Seongnam-si | Gyeonggi-do | 13601 | South Korea |
| Haeundae Jaseng Hospital of Korean Medicine | Busan | South Korea |
| Daejeon Jaseng Hospital of Korean Medicine | Daejeon | 35262 | South Korea |