Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial

Study Overview
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Brief Summary
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This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain.

Detailed Description
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This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (50:50) for pharmacopuncture therapy group and physical therapy group. Participants of each group will receive total 5 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 type and volume of pharmacopuncture and physical therapy.

Official Title
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Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial

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 Numeric rating scale (NRS) score for low back pain 5 or more 19-70 years old participants who agreed and signed informed consent form Exclusion Criteria: Spine metastasis of cancer, acute fracture of spine, or spine dislocation Progressive neurologic deficits or severe neurologic deficits Soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc) Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc) Concurrent use of steroids, immunosuppressants, or psychotropic medications 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 lumbar 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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No

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>Pharmacopuncture will be administered to the subjects in the pharmacopuncture therapy group. The physicians will choose the specific type and volume of pharmacopuncture according to participants' conditions. | Procedure: pharmacopuncture therapy<br>* The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and dosage will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively.<br>|
| Active Comparator: Physical therapy<br>Physical therapy will be applied to the subjects in the physical therapy group. The physicians will choose the specific type and volume of pharmacopuncture according to participants' conditions. | Procedure: physical therapy<br>* The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and body part will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale (NRS) of low-back 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 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale (NRS) of low-back 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, 13, 25 | 
| Numeric rating scale (NRS) of radiating pain in lower extremities | 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, 13, 25 | 
| 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, 13, 25 | 
| 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. | week 1, 2, 3, 4, 5, 6, 13, 25 | 
| 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, 13, 25 | 
| 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, 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 6, 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, 6, 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, 6, 13, 25 |