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

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 SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. low back pain for more than 6 months
  2. Visual Analogue Scale (VAS) of low back pain is more than 5
  3. 19-70 years old
  4. participants who agreed and wrote informed consents

Exclusion Criteria:

  1. Migration of cancer reaching to spine, fracture of spine
  2. Progressive neurologic deficits or severe neurologic deficits
  3. Cancer, fibromyalgia, RA, or goat
  4. Stroke, MI, kidney disease, dimentia, diabetic neuropathy, or epilepsy
  5. Participants taking steroid, immunosuppressant, or psychotropic medication
  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 cervical 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

The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.

The physicians will choose the type and time of physical therapy according to participants' conditions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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'.
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
September 29, 2020
Last Updated
August 26, 2021
Sponsor
Jaseng Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04576520
Brief Title
PCT of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study
Official Title
Pragmatic Randomized Controlled Trial of Pharmacopuncture Therapy for Chronic Low Back Pain : A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
March 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Medical Foundation

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 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
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.

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
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pharmacopuncture therapy
Arm Type
Experimental
Arm Description
The physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
Arm Title
physical therapy
Arm Type
Active Comparator
Arm Description
The physicians will choose the type and time of physical therapy according to participants' conditions.
Intervention Type
Procedure
Intervention Name(s)
pharmacopuncture therapy
Intervention Description
This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
Intervention Type
Procedure
Intervention Name(s)
physical therapy
Intervention Description
This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.
Primary Outcome Measure Information:
Title
Visual analogue scale (VAS) of low back pain
Description
Visual analogue scale of low back pain, minimum 0 to maximum 100, which is a higher score means a worse outcome.
Time Frame
Change from baseline VAS at week 6
Secondary Outcome Measure Information:
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, 10, 16
Title
Numeric rating scale (NRS) of low back pain and leg radiating 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, 10, 16
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, 10, 16
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, 10, 16
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, 10, 16
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, 10, 16
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, 10, 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, 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
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

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

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