Clinical trial NCT03132974: 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: 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 -
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Chronic Low Back Pain
Lead sponsor: Gachon University Gil Oriental Medical Hospital
Sponsor class: OTHER
Collaborators: name: Daejeon University
name: Semyung University Korean Medicine Hospital in Chungju
name: Woosuk University Oriental Medical Center
First posted: 2017-04-28
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change from Baseline in Numeric Rating Scale of Pain
timeFrame: Screening Visit, At baseline, week 2, 4, 6, 8
Secondary outcomes:
measure: Change from Baseline in 'Roland Morris Disability Questionnaire'
timeFrame: Screening Visit, At baseline, week 2, 4, 6, 8
measure: Change from Baseline in European Quality of life 5 Dimension
timeFrame: Screening Visit, At baseline, week 2, 4, 6, 8
Other outcomes:
measure: Change from baseline in pelvic incidence
timeFrame: At baseline, week 4, 8
measure: Change from baseline in iliac crest height
timeFrame: At baseline, week 4, 8
measure: Change from baseline in lumbar gravity line
timeFrame: At baseline, week 4, 8
measure: Change from baseline in lumbar lordotic angle
timeFrame: At baseline, week 4, 8
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Oriental Medicine Hospital
Study officials:
affiliation: Gachon University Gil Oriental Medical Hospital
name: Yun-Kyung Song, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.