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 -

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Drug: Sogyeonghwalhyeol-tang granule; Other: Sogyeonghwalhyeol-tang granule with manipulation procedure; Other: Placebo with manipulation procedure

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Youme Ko, MA; Phone Number: 8229619278; Email: iseeymk@gmail.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 22318
    • Recruiting
    • Gachon University Gil Oriental Medicine Hospital
    • Contact: Hyun Joo Kim, PhD; Phone Number: 82327701369

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SGHH; Admission to Sogyeonghwalhyeol-tang granule	Drug: Sogyeonghwalhyeol-tang granule; Sogyeonghwalhyeol-tang herbal extract granule
Experimental: SGHH with manipulation therapy; Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy	Other: Sogyeonghwalhyeol-tang granule with manipulation procedure; Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure
Placebo Comparator: Placebo with manipulation therapy	Other: Placebo with manipulation procedure; Placebo granule with manipulation procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Screening Visit, At baseline, week 2, 4, 6, 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Screening Visit, At baseline, week 2, 4, 6, 8
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.	Screening Visit, At baseline, week 2, 4, 6, 8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pelvic incidence	angle between the line perpendicular to the sacral plate and the line connecting the midpoint of the sacral plate to the bicoxofemoral axis.	At baseline, week 4, 8
Change from baseline in iliac crest height	A measure of the vertical distance from the top of the iliac crest to the floor while the subject stands.	At baseline, week 4, 8
Change from baseline in lumbar gravity line	created by first locating center of the L3 body & then droping a line downward from there, perpendicular to the bottom of the film.	At baseline, week 4, 8
Change from baseline in lumbar lordotic angle	the angle between the top (superior surface) of the second lumbar vertebra and the bottom (inferior surface) of the fifth lumbar vertebra	At baseline, week 4, 8

Collaborators and Investigators

• Sponsor: Gachon University Gil Oriental Medical Hospital
• Collaborators: Daejeon University; Semyung University Korean Medicine Hospital in Chungju; Woosuk University Oriental Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 27, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: ISEE_2017_LBP

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