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Evaluation of Efficacy and Safety of Single and Multiple Therapy of Herbal Medicine/Chuna Therapy on Non-specific Chronic Low Back Pain: A Study Protocol for Multicenter, 3-arm, Randomized, Single Blinded, Parallel Group, Incomplete Factorial Design, Pilot Study -

Primary Purpose

Chronic Low Back Pain

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Sogyeonghwalhyeol-tang granule

Sogyeonghwalhyeol-tang granule with manipulation procedure

Placebo with manipulation procedure

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inpatients with chief complaint of low back pain in oriental rehabilitation medical center
Age 19 - 65
Patients who have 4 ~7 cm of VAS pain score;
Ability to have normal communication
Ability to give informed consent

Exclusion Criteria:

Patients with pain duration of 3 months or less
Patients with progressive neurologic deficit or severe neurologic symptoms by SLR test
Patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, etc)
Patients with spondylolisthesis or spondylolysis(diagnosed with grade II or higher level)
Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
Patients with history of spinal surgery
Patients with more severe pain than pain caused by low back pain
Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis etc.
Patients with history of Medical Malpractice Case
Patients with treatment history of low back pain within 1 month either KM or WM
Patients participating in other clinical studies within 3 months
Pregnant patients or patients with plans of pregnancy or lactating patients
Patients disagree to sign the informed consent form
Patients deemed unsuitable for participating the trial by the researchers

Sites / Locations

Gachon University Gil Oriental Medicine HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

SGHH

SGHH with manipulation therapy

Placebo with manipulation therapy

Arm Description

Admission to Sogyeonghwalhyeol-tang granule

Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy

Outcomes

Primary Outcome Measures

Change from Baseline in Numeric Rating Scale of Pain

A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.

Secondary Outcome Measures

Change from Baseline in 'Roland Morris Disability Questionnaire'

This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.

Change from Baseline in European Quality of life 5 Dimension

The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state.

Full Information

NCT ID

NCT03132974

First Posted

April 19, 2017

Last Updated

March 27, 2021

Sponsor

Gachon University Gil Oriental Medical Hospital

Collaborators

Daejeon University, Semyung University Korean Medicine Hospital in Chungju, Woosuk University Oriental Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03132974

Brief Title

Evaluation of Efficacy and Safety of Single and Multiple Therapy of Herbal Medicine/Chuna Therapy on Non-specific Chronic Low Back Pain: A Study Protocol for Multicenter, 3-arm, Randomized, Single Blinded, Parallel Group, Incomplete Factorial Design, Pilot Study -

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

December 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gachon University Gil Oriental Medical Hospital

Collaborators

Daejeon University, Semyung University Korean Medicine Hospital in Chungju, Woosuk University Oriental Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Purpose of this trial is to investigate the efficacy and safety of herbal medicine with manipulation therapy on Korean Patients with Chronic Low Back Pain

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

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SGHH

Arm Type

Experimental

Arm Description

Admission to Sogyeonghwalhyeol-tang granule

Arm Title

SGHH with manipulation therapy

Arm Type

Experimental

Arm Description

Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy

Arm Title

Placebo with manipulation therapy

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Sogyeonghwalhyeol-tang granule

Intervention Description

Sogyeonghwalhyeol-tang herbal extract granule

Intervention Type

Other

Intervention Name(s)

Sogyeonghwalhyeol-tang granule with manipulation procedure

Intervention Description

Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure

Intervention Type

Other

Intervention Name(s)

Placebo with manipulation procedure

Intervention Description

Placebo granule with manipulation procedure

Primary Outcome Measure Information:

Title

Change from Baseline in Numeric Rating Scale of Pain

Description

A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.

Time Frame

Screening Visit, At baseline, week 2, 4, 6, 8

Secondary Outcome Measure Information:

Title

Change from Baseline in 'Roland Morris Disability Questionnaire'

Description

Time Frame

Screening Visit, At baseline, week 2, 4, 6, 8

Title

Change from Baseline in European Quality of life 5 Dimension

Description

Time Frame

Screening Visit, At baseline, week 2, 4, 6, 8

Other Pre-specified Outcome Measures:

Title

Change from baseline in pelvic incidence

Description

angle between the line perpendicular to the sacral plate and the line connecting the midpoint of the sacral plate to the bicoxofemoral axis.

Time Frame

At baseline, week 4, 8

Title

Change from baseline in iliac crest height

Description

A measure of the vertical distance from the top of the iliac crest to the floor while the subject stands.

Time Frame

At baseline, week 4, 8

Title

Change from baseline in lumbar gravity line

Description

created by first locating center of the L3 body & then droping a line downward from there, perpendicular to the bottom of the film.

Time Frame

At baseline, week 4, 8

Title

Change from baseline in lumbar lordotic angle

Description

the angle between the top (superior surface) of the second lumbar vertebra and the bottom (inferior surface) of the fifth lumbar vertebra

Time Frame

At baseline, week 4, 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Inpatients with chief complaint of low back pain in oriental rehabilitation medical center Age 19 - 65 Patients who have 4 ~7 cm of VAS pain score; Ability to have normal communication Ability to give informed consent Exclusion Criteria: Patients with pain duration of 3 months or less Patients with progressive neurologic deficit or severe neurologic symptoms by SLR test Patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, etc) Patients with spondylolisthesis or spondylolysis(diagnosed with grade II or higher level) Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results Patients with history of spinal surgery Patients with more severe pain than pain caused by low back pain Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis etc. Patients with history of Medical Malpractice Case Patients with treatment history of low back pain within 1 month either KM or WM Patients participating in other clinical studies within 3 months Pregnant patients or patients with plans of pregnancy or lactating patients Patients disagree to sign the informed consent form Patients deemed unsuitable for participating the trial by the researchers

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Youme Ko, MA

Phone

8229619278

iseeymk@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yun-Kyung Song, PhD

Organizational Affiliation

Gachon University Gil Oriental Medical Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gachon University Gil Oriental Medicine Hospital

City

Incheon

ZIP/Postal Code

22318

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hyun Joo Kim, PhD

Phone

82327701369

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32791704

Citation

Ko Y, Jang BH, Oh MS, Kim SJ, Ko YS, Ha IH, Lee EJ, Kim MR, Song YK, Ko SG. Evaluation of efficacy and safety of single and multiple therapy of herbal medicine/Chuna therapy on non-specific chronic low back pain: A study protocol for multicenter, 3-arm, randomized, single blinded, parallel group, incomplete factorial design, pilot study. Medicine (Baltimore). 2020 Jul 24;99(30):e21260. doi: 10.1097/MD.0000000000021260.

Results Reference

derived

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