Low Back Pain With RadiculopathyPhase 3NCT02196129
Immediate Pain Relieving Effects of Sinbaro-3 for Low Back Pain
A Phase 3 study testing Sinbaro-3 and Hwangryun in people with Low Back Pain With Radiculopathy and Low Back Pain Without Radiculopathy, run by Jaseng Hospital of Korean Medicine at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the immediate pain relieving effects of sinbaro-3 pharmaco-acupuncture in patients with low back pain admitted for inpatient care Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Low Back Pain With Radiculopathy, Low Back Pain Without Radiculopathy, Herniated Intervertebral Disc
- What is being tested?
- Sinbaro-3 and Hwangryun
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Nov 2014
- Phase
- Phase 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to a Korean Medicine hospital for low back pain with or without radiculopathy
- Age between 18 and 69
- NRS score of >6 on the day of the intervention
- Voluntary participation with written consent given to study consent form
Who cannot join
- Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc.
- Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
- Progressive neurologic deficit(s) or concurrent severe neurological symptoms
- Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc.
- Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher
- Experience of gastroenteric complications after taking NSAIDs or currently undergoing treatment for digestive disorders
- During pregnancy or suspected pregnancy
- Subjects considered unsuitable for clinical trial by the researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: Immediate Pain Relieving Effects of Sinbaro-3 Pharmaco-acupuncture in Low Back Pain Patients; A Randomized Controlled Trial
The purpose of this study is to investigate the immediate pain relieving effects of sinbaro-3 pharmaco-acupuncture in patients with low back pain admitted for inpatient care
Read the detailed description
60 patients with LBP with moderate to severe pain(NRS>6) were randomly allocated to 2 groups. The experimental group was treated with sinbaro-3 pharmacoacupuncture and the control group was treated with Hwangryun pharmacoacupuncture. All administrations were limited to 1 session, and comparisons of measurements were made before and after treatment. Primary outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to measure primary outcomes at 30 minutes, 2hours, 4hours, and 6 hours after treatment. Before and after each measurement, the patients are asked to stand up and rotate their torso. At termination of the study, satisfaction levels of the patient's current status will also be collected.
- Conditions
- Low Back Pain With Radiculopathy, Low Back Pain Without Radiculopathy, Herniated Intervertebral Disc
- Being tested
- Sinbaro-3, Hwangryun
- Keywords
- low back pain, pharmacoacupuncture, sinbaro-3
- Medical subject headings
- Intervertebral Disc Displacement, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinbaro-3Drug
Also called Harpagophytum Procumbens
1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain
HwangryunDrug
1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain
| Study group | Role | What they receive |
|---|---|---|
| Sinbaro-3 | Experimental | 1cc Harpagophytum Procumbens(freeze drying) pharmacoacupuncture adminstered to 6 acupoints at the site of pain Administered once and once only before any interventions Receives: Drug: Sinbaro-3 |
| Hwangryun(distillation) | Placebo comparator | 1cc Hwangryun(distillation) pharmaco-acupuncture administered to 6 acupoints at the site of pain Administered once and once only before any other intervention Receives: Drug: Hwangryun |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
Measured: At baseline
Visual Analogue Scale
The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
Measured: 30 minutes following treatment
Visual Analogue Scale
The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
Measured: 2 hours following treatment
Visual Analogue Scale
The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
Measured: 4 hours following treatment
Visual Analogue Scale
The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
Measured: 6 hours following treatment
Secondary outcomes (1)
Satisfaction levels
7-point Likert scale
Measured: 6hrs following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain With RadiculopathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Hospital of Korean Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, Jaseng Hospital of Korean Medicine
- Investigators
- Joonshik Shin, Principal investigator, Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196129
- Sponsor's protocol ID
- JS-CT-2014-02
- Status last verified
- Nov 2018
- First submitted
- 11 Jul 2014
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Pain Relieving Effects of Sinbaro-3 Pharmaco-acupuncture in Low Back Pain Patients; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02196129
- Acronym / sponsor ID
- JS-CT-2014-02
- Conditions
- Low Back Pain With Radiculopathy, Low Back Pain Without Radiculopathy, Herniated Intervertebral Disc
- Keywords
- low back pain, pharmacoacupuncture, sinbaro-3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jaseng Hospital of Korean MedicineUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 21 Jul 2014 (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 study is to investigate the immediate pain relieving effects of sinbaro-3 pharmaco-acupuncture in patients with low back pain admitted for inpatient care
Detailed description
60 patients with LBP with moderate to severe pain(NRS>6) were randomly allocated to 2 groups. The experimental group was treated with sinbaro-3 pharmacoacupuncture and the control group was treated with Hwangryun pharmacoacupuncture. All administrations were limited to 1 session, and comparisons of measurements were made before and after treatment. Primary outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to measure primary outcomes at 30 minutes, 2hours, 4hours, and 6 hours after treatment. Before and after each measurement, the patients are asked to stand up and rotate their torso. At termination of the study, satisfaction levels of the patient's current status will also be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinbaro-3 | Experimental | Drug: Sinbaro-31cc Harpagophytum Procumbens(freeze drying) pharmacoacupuncture adminstered to 6 acupoints at the site of pain Administered once and once only before any interventions |
| Hwangryun(distillation) | Placebo comparator | Drug: Hwangryun1cc Hwangryun(distillation) pharmaco-acupuncture administered to 6 acupoints at the site of pain Administered once and once only before any other intervention |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted to a Korean Medicine hospital for low back pain with or without radiculopathy
- Age between 18 and 69
- NRS score of >6 on the day of the intervention
- Voluntary participation with written consent given to study consent form
Key exclusion criteria (8 listed)
- Diagnosis of serious disease(s) which are possible causes of back pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equina compression, etc.
- Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.
- Progressive neurologic deficit(s) or concurrent severe neurological symptoms
- Unsuitable for or at risk of complications from acupuncture treatment such as patients with clotting disorders, severe diabetes with risk of infection, serious cardiovascular disease, or undergoing anticoagulant treatment, etc.
- Under prescription of corticosteroids, immuno-suppressant drugs, psychiatric medicine, or other medication considered unsuitable for subjects by the researcher
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 |
|---|---|---|
| Sinbaro-3Also: Harpagophytum Procumbens1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain | Drug | Sinbaro-3 |
| Hwangryun1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain | Drug | Hwangryun(distillation) |
Primary outcome
Visual Analogue Scale
Time frame: At baseline
The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
Visual Analogue Scale
Time frame: 30 minutes following treatment
The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
Visual Analogue Scale
Time frame: 2 hours following treatment
The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
Visual Analogue Scale
Time frame: 4 hours following treatment
The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
Visual Analogue Scale
Time frame: 6 hours following treatment
The patient is asked to stand up and roatate the torso to the left and right, then asked to mark on the visual analogue scale the intensity of the pain they are experiencing
1 secondary outcome
Satisfaction levels
Time frame: 6hrs following treatment
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 7 Nov 2018.
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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.
Joonshik Shin principal investigator
Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sinbaro-3 and Hwangryun in people with Low Back Pain With Radiculopathy and Low Back Pain Without Radiculopathy, run by Jaseng Hospital of Korean Medicine 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 4 inclusion and 8 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 7 Nov 2018. 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 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?
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?
Visual Analogue Scale (time frame: At baseline). The study lists 5 primary outcomes in all. 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 7 Nov 2018.