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 -

NCT03132974 | Unknown Phase 2 DMC

• 1 other identifier: ISEE_2017_LBP
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Baseline in 'Roland Morris Disability Questionnaire'

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

• Change from Baseline in European Quality of life 5 Dimension

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

Other Outcomes (4)

• Change from baseline in pelvic incidence

  At baseline, week 4, 8

• Change from baseline in iliac crest height

  At baseline, week 4, 8

• Change from baseline in lumbar gravity line

  At baseline, week 4, 8

Study Arms (3)

SGHH

EXPERIMENTAL

Admission to Sogyeonghwalhyeol-tang granule

Drug: Sogyeonghwalhyeol-tang granule

SGHH with manipulation therapy

EXPERIMENTAL

Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy

Other: Sogyeonghwalhyeol-tang granule with manipulation procedure

Placebo with manipulation therapy

PLACEBO COMPARATOR

Other: Placebo with manipulation procedure

Interventions

Sogyeonghwalhyeol-tang granule DRUG

Sogyeonghwalhyeol-tang herbal extract granule

SGHH

Sogyeonghwalhyeol-tang granule with manipulation procedure OTHER

Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure

SGHH with manipulation therapy

Placebo with manipulation procedure OTHER

Placebo granule with manipulation procedure

Placebo with manipulation therapy

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gachon University Gil Oriental Medical Hospital: lead
• Daejeon University: collaborator
• Semyung University Korean Medicine Hospital in Chungju: collaborator
• Woosuk University Oriental Medical Center: collaborator

Study Sites (1)

Gachon University Gil Oriental Medicine Hospital

Incheon, 22318, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 32791704 DERIVED

Study Officials

• Yun-Kyung Song, PhD

  Gachon University Gil Oriental Medical Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youme Ko, MA

CONTACT

8229619278; iseeymk@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 28, 2017
• Study Start: September 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)