- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04833309
Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial
December 19, 2022 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: In-Hyuk Ha, KMD,Ph.D
- Phone Number: +82-2-2222-2740
- Email: hanihata@gmail.com
Study Locations
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Busan, Korea, Republic of, 48102
- Haeundae Jaseng Hospital of Korean Medicine
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Daejeon, Korea, Republic of, 35262
- Daejeon Jaseng Hospital of Korean Medicine
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Gangnam-Gu
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Seoul, Gangnam-Gu, Korea, Republic of, 135-896
- Jaseng Hospital of Korean Medicine
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Gyeonggi Province
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Bucheon, Gyeonggi Province, Korea, Republic of, 14598
- Bucheon Jaseng Hospital of Korean Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pharmacopuncture therapy
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.
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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.
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Active Comparator: Physical therapy
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric rating scale (NRS) of low-back pain
Time Frame: week 6
|
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'.
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week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric rating scale (NRS) of low-back pain
Time Frame: week 1, 2, 3, 4, 5, 6, 13, 25
|
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'.
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week 1, 2, 3, 4, 5, 6, 13, 25
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Numeric rating scale (NRS) of radiating pain in lower extremities
Time Frame: week 1, 2, 3, 4, 5, 6, 13, 25
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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'.
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week 1, 2, 3, 4, 5, 6, 13, 25
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Visual analogue scale (VAS) of leg radiating pain
Time Frame: week 1, 2, 3, 4, 5, 6, 13, 25
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Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
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week 1, 2, 3, 4, 5, 6, 13, 25
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Visual analogue scale (VAS) of low-back pain
Time Frame: week 1, 2, 3, 4, 5, 6, 13, 25
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Visual analogue scale of radiating leg pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
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week 1, 2, 3, 4, 5, 6, 13, 25
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Oswestry Disability Index (ODI)
Time Frame: week 1, 6, 13, 25
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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).
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week 1, 6, 13, 25
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Korean version of the Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: week 1, 6, 13, 25
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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).
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week 1, 6, 13, 25
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Patient Global Impression of Change (PGIC)
Time Frame: week 6, 13, 25
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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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week 6, 13, 25
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Short Form-12 Health Survey version 2 (SF-12 v2)
Time Frame: week 1, 6, 13, 25
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The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
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week 1, 6, 13, 25
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EuroQol-5 Dimension (EQ-5D-5L)
Time Frame: week 1, 6, 13, 25
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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)
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week 1, 6, 13, 25
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: In-Hyuk Ha, KMD,Ph.D, Jaseng Medical Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2021
Primary Completion (Actual)
February 26, 2022
Study Completion (Actual)
February 26, 2022
Study Registration Dates
First Submitted
April 4, 2021
First Submitted That Met QC Criteria
April 4, 2021
First Posted (Actual)
April 6, 2021
Study Record Updates
Last Update Posted (Actual)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 19, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS-CT-2021-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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