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

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pharmacopuncture therapy
physical therapy
Sponsored by
Jaseng Medical Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. low back pain for more than 6 months
  2. Numeric rating scale (NRS) score for low back pain 5 or more
  3. 19-70 years old
  4. participants who agreed and signed informed consent form

Exclusion Criteria:

  1. Spine metastasis of cancer, acute fracture of spine, or spine dislocation
  2. Progressive neurologic deficits or severe neurologic deficits
  3. Soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc)
  4. Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
  5. Concurrent use of steroids, immunosuppressants, or psychotropic medications
  6. Hemorrhagic disease, severe diabetes or taking anticoagulant drug
  7. Participants who took NSAIDs or pharmacopuncture within 1 week
  8. Pregnant or lactating women
  9. Participants who had undergone lumbar surgery within 3 months
  10. 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
  11. Participants who can not write informed consent
  12. Participants who is difficult to participate in the trial according to investigator's decision

Sites / Locations

  • Jaseng Hospital of Korean Medicine
  • Bucheon Jaseng Hospital of Korean Medicine
  • Haeundae Jaseng Hospital of Korean Medicine
  • Daejeon Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pharmacopuncture therapy

Physical therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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'.
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'.
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.
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.
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).
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).
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.)
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.
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)

Full Information

First Posted
April 4, 2021
Last Updated
December 19, 2022
Sponsor
Jaseng Medical Foundation
Collaborators
Korea Institute of Oriental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04833309
Brief Title
Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial
Official Title
Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2021 (Actual)
Primary Completion Date
February 26, 2022 (Actual)
Study Completion Date
February 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation
Collaborators
Korea Institute of Oriental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacopuncture therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
pharmacopuncture therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric rating scale (NRS) of low-back pain
Description
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 6
Secondary Outcome Measure Information:
Title
Numeric rating scale (NRS) of low-back pain
Description
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, 13, 25
Title
Numeric rating scale (NRS) of radiating pain in lower extremities
Description
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, 13, 25
Title
Visual analogue scale (VAS) of leg radiating pain
Description
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, 13, 25
Title
Visual analogue scale (VAS) of low-back pain
Description
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, 13, 25
Title
Oswestry Disability Index (ODI)
Description
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).
Time Frame
week 1, 6, 13, 25
Title
Korean version of the Roland-Morris Disability Questionnaire (RMDQ)
Description
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).
Time Frame
week 1, 6, 13, 25
Title
Patient Global Impression of Change (PGIC)
Description
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 6, 13, 25
Title
Short Form-12 Health Survey version 2 (SF-12 v2)
Description
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Time Frame
week 1, 6, 13, 25
Title
EuroQol-5 Dimension (EQ-5D-5L)
Description
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, 6, 13, 25

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, KMD,Ph.D
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Study Director
Facility Information:
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-896
Country
Korea, Republic of
Facility Name
Bucheon Jaseng Hospital of Korean Medicine
City
Bucheon
State/Province
Gyeonggi Province
ZIP/Postal Code
14598
Country
Korea, Republic of
Facility Name
Haeundae Jaseng Hospital of Korean Medicine
City
Busan
ZIP/Postal Code
48102
Country
Korea, Republic of
Facility Name
Daejeon Jaseng Hospital of Korean Medicine
City
Daejeon
ZIP/Postal Code
35262
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36072909
Citation
Park KS, Kim S, Seo JY, Cho H, Lee JY, Lee YJ, Lee J, Kim MJ, Choi YE, Yang CS, Han CH, Ha IH. Effectiveness and Safety of Pharmacopuncture Therapy for Chronic Low Back Pain: A Protocol for a Pragmatic Randomized Controlled Trial. J Pain Res. 2022 Sep 1;15:2629-2639. doi: 10.2147/JPR.S375231. eCollection 2022.
Results Reference
derived

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

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