PCT of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Procedure: pharmacopuncture therapy
* Procedure: physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: low back pain for more than 6 months Visual Analogue Scale (VAS) of low back pain is more than 5 19-70 years old participants who agreed and wrote informed consents Exclusion Criteria: Migration of cancer reaching to spine, fracture of spine Progressive neurologic deficits or severe neurologic deficits Cancer, fibromyalgia, RA, or goat Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy Participants taking steroid, immunosuppressant, or psychotropic medication Hemorrhagic disease, severe diabetes or taking anticoagulant drug Participants who took NSAIDs or pharmacopuncture within 1 week Pregnant or lactating women Participants who had undergone cervical surgery within 3 months Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial Participants who can not write informed consent Participants who is difficult to participate in the trial according to investigator's decision

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pharmacopuncture therapy<br>The physicians will choose the type and volume of pharmacopuncture according to participants' conditions. | Procedure: pharmacopuncture therapy<br>* This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.<br>|
| Active Comparator: physical therapy<br>The physicians will choose the type and time of physical therapy according to participants' conditions. | Procedure: physical therapy<br>* This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline VAS at week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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'. | 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). | 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). | 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.) | 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. | 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) | Week 1, 6, 10, 16 |