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 -

Chronic Low Back Pain Clinical Trial

Official 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 -

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03132974
• Other study ID #: ISEE_2017_LBP
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Gachon University Gil Oriental Medical Hospital
• Contact: Youme Ko, MA
• Phone: 8229619278
• Email: iseeymk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• Sogyeonghwalhyeol-tang granule
Sogyeonghwalhyeol-tang herbal extract granule

Other:
• Sogyeonghwalhyeol-tang granule with manipulation procedure
Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure
• Placebo with manipulation procedure
Placebo granule with manipulation procedure

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Oriental Medicine Hospital	Incheon

Sponsors (4)

Lead Sponsor	Collaborator
Gachon University Gil Oriental Medical Hospital	Daejeon University, Semyung University Korean Medicine Hospital in Chungju, Woosuk University Oriental Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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