Chronic Low Back PainPhase 2/3NCT03132974
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 -
A Phase 2/3 study testing Sogyeonghwalhyeol-tang granule and Sogyeonghwalhyeol-tang granule with manipulation procedure in people with Chronic Low Back Pain, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Sogyeonghwalhyeol-tang granule and Sogyeonghwalhyeol-tang granule with manipulation procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2018to 31 Dec 2021
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Oriental Medicine Hospital
Incheon, 22318
Hyun Joo Kim, PhD, 82327701369
About this 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
- Conditions
- Chronic Low Back Pain
- Being tested
- Sogyeonghwalhyeol-tang granule, Sogyeonghwalhyeol-tang granule with manipulation procedure, Placebo with manipulation procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sogyeonghwalhyeol-tang granuleDrug
Sogyeonghwalhyeol-tang herbal extract granule
Sogyeonghwalhyeol-tang granule with manipulation procedureOther
Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure
Placebo with manipulation procedureOther
Placebo granule with manipulation procedure
| Study group | Role | What they receive |
|---|---|---|
| SGHH | Experimental | Admission to Sogyeonghwalhyeol-tang granule Receives: Drug: Sogyeonghwalhyeol-tang granule |
| SGHH with manipulation therapy | Experimental | Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy Receives: Other: Sogyeonghwalhyeol-tang granule with manipulation procedure |
| Placebo with manipulation therapy | Placebo comparator | Not described Receives: Other: Placebo with manipulation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening Visit, At baseline, week 2, 4, 6, 8
Secondary outcomes (2)
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.
Measured: 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.
Measured: Screening Visit, At baseline, week 2, 4, 6, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Sep 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Oriental Medical Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daejeon University, Semyung University Korean Medicine Hospital in Chungju, Woosuk University Oriental Medical Center
- Responsible party
- Principal investigator, Yun-Kyung Song, Gachon University Gil Oriental Medical Hospital
- Investigators
- Yun-Kyung Song, PhD, Principal investigator, Gachon University Gil Oriental Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132974
- Sponsor's protocol ID
- ISEE_2017_LBP
- Status last verified
- Mar 2021
- First submitted
- 19 Apr 2017
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32791704
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 -
- ClinicalTrials.gov ID
- NCT03132974
- Acronym / sponsor ID
- ISEE_2017_LBP
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gachon University Gil Oriental Medical HospitalUniversity, hospital or other
- Collaborators
- Daejeon University, Semyung University Korean Medicine Hospital in Chungju, Woosuk University Oriental Medical Center
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SGHH | Experimental | Drug: Sogyeonghwalhyeol-tang granuleAdmission to Sogyeonghwalhyeol-tang granule |
| SGHH with manipulation therapy | Experimental | Other: Sogyeonghwalhyeol-tang granule with manipulation procedureAdmission to Sogyeonghwalhyeol-tang granule and manipulation therapy |
| Placebo with manipulation therapy | Placebo comparator | Other: Placebo with manipulation procedure |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sogyeonghwalhyeol-tang granuleSogyeonghwalhyeol-tang herbal extract granule | Drug | SGHH |
| Sogyeonghwalhyeol-tang granule with manipulation procedureSogyeonghwalhyeol-tang herbal extract granule with manipulation procedure | Other | SGHH with manipulation therapy |
| Placebo with manipulation procedurePlacebo granule with manipulation procedure | Other | Placebo with manipulation therapy |
Primary outcome
Change from Baseline in Numeric Rating Scale of Pain
Time frame: Screening Visit, At baseline, week 2, 4, 6, 8
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.
2 secondary outcomes
Change from Baseline in 'Roland Morris Disability Questionnaire'
Time frame: Screening Visit, At baseline, week 2, 4, 6, 8
Change from Baseline in European Quality of life 5 Dimension
Time frame: Screening Visit, At baseline, week 2, 4, 6, 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 32791704Ko 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Kyung Song, PhD principal investigator
Gachon University Gil Oriental Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sogyeonghwalhyeol-tang granule and Sogyeonghwalhyeol-tang granule with manipulation procedure in people with Chronic Low Back Pain, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youme Ko, MA (8229619278, iseeymk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Numeric Rating Scale of Pain (time frame: Screening Visit, At baseline, week 2, 4, 6, 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03132974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.