Low Back PainPhase 4WRMDNCT02988232
Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain
A Phase 4 study testing Sogyeonghwalhyeol-tang in people with Low Back Pain and Workplace, 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 Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Low Back Pain, Workplace
- What is being tested?
- Sogyeonghwalhyeol-tang
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2016to 30 Dec 2020
- Phase
- Phase 4
- 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
- Workplace Vulnerable populations(hospital workers, office worker, blue collar workers, transit workers)
- Patients must include all of the following symptoms:
- Those who have 4 ~7 cm of VAS pain score;
- Those who has classified as 'at risk non-complier' or 'pain complaints' by KOSHA questionnaire
- 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.
About this study
Official title: Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain: a Multicenter, Randomized, Controlled, Clinical Trial
The Purpose of this trial is to investigate the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain
Read the detailed description
Investigating the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work-related Chronic Low Back Pain
- Conditions
- Low Back Pain, Workplace
- Being tested
- Sogyeonghwalhyeol-tang, Placebo
- Keywords
- Work Related Chronic Low Back Pain, Korean Medicine, Sogyeonghwalhyeol-tang
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sogyeonghwalhyeol-tangDrug
Also called SGHH
herbal extract
PlaceboDrug
extract powder with same appearance, odor and color as SGHH
| Study group | Role | What they receive |
|---|---|---|
| Treatment(SGHH) | Experimental | Admission to Sogyeonghwalhyeol-tang granule Receives: Drug: Sogyeonghwalhyeol-tang |
| Placebo | Placebo comparator | admission to placebo Receives: Drug: Placebo |
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 posted9 Dec 2016 (estimated)
- Study start1 Jul 2016
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Oriental Medical Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sangji University Oriental Medical Center, Korea, Semyung University Korean Medicine Hospital in Chungju, Korea, Daejeon University
- Responsible party
- Principal investigator, Yun-Kyung Song, Gachon University Gil Oriental Medical Hospital
- Investigators
- Yun-Kyung Song, PhD, Principal investigator, Gachon University of Oriental Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988232
- Sponsor's protocol ID
- ISEE_2015_WRMD
- Acronym
- WRMD
- Status last verified
- Apr 2021
- First submitted
- 7 Dec 2016
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain: a Multicenter, Randomized, Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT02988232
- Acronym / sponsor ID
- WRMD / ISEE_2015_WRMD
- Conditions
- Low Back Pain, Workplace
- Keywords
- Work Related Chronic Low Back Pain, Korean Medicine, Sogyeonghwalhyeol-tang
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gachon University Gil Oriental Medical HospitalUniversity, hospital or other
- Collaborators
- Sangji University Oriental Medical Center, Korea, Semyung University Korean Medicine Hospital in Chungju, Korea, Daejeon University
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 9 Dec 2016 (estimated)
- 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 Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain
Detailed description
Investigating the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work-related Chronic Low Back Pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment(SGHH) | Experimental | Drug: Sogyeonghwalhyeol-tangAdmission to Sogyeonghwalhyeol-tang granule |
| Placebo | Placebo comparator | Drug: Placeboadmission to placebo |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Inpatients with chief complaint of low back pain in oriental rehabilitation medical center
- Age 19 - 65
- Workplace Vulnerable populations(hospital workers, office worker, blue collar workers, transit workers)
- Patients must include all of the following symptoms:
- Ability to have normal communication
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-tangAlso: SGHHherbal extract | Drug | Treatment(SGHH) |
| Placeboextract powder with same appearance, odor and color as SGHH | Drug | Placebo |
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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 of Oriental Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sogyeonghwalhyeol-tang in people with Low Back Pain and Workplace, 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 8 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: finished, as of the sponsor's last update on 12 Apr 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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 12 Apr 2021.