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

NCT ID: NCT04576520

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2021-03-26

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.

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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pharmacopuncture therapy

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

Group Type EXPERIMENTAL

pharmacopuncture therapy

Intervention Type PROCEDURE

This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.

physical therapy

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

Group Type ACTIVE_COMPARATOR

physical therapy

Intervention Type PROCEDURE

This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.

Interventions

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pharmacopuncture therapy

This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.

Intervention Type PROCEDURE

physical therapy

This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jaseng Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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In-Hyuk Ha, KMD

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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In-Hyuk Ha, Ph.D

Role: STUDY_DIRECTOR

Jaseng Medical Foundation

Locations

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Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Site Status

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, South Korea

Site Status

Haeundae Jaseng Hospital of Korean Medicine

Busan, , South Korea

Site Status

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JS-CT-2020-09

Identifier Type: -

Identifier Source: org_study_id

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