SciaticaNCT01989403
Alternative and Integrative Therapy for Lumbar Disk Herniation
An observational study of Sciatica and Intervertebral Disc Disorder, run by Jaseng Hospital of Korean Medicine at 1 site in South Korea.
Trial summary
The investigators report management of lumbar disc herniation with severe sciatic pain using an integrative complementary and alternative medicine approach with a 5 year follow-up. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sciatica, Intervertebral Disc Disorder
- What is being tested?
- herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2006to Mar 2013
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: integrative hospital that offers both Western and traditional Korean medical services
Who may be able to join
- LBP with sciatica,
- A numeral rating scale (NRS) leg pain intensity of 5 or higher
- Onset within 1 year;
- Lumbar Disk Heriation confirmed by MRI;
- Written consent to attend 6 months of integrative CAM treatment and following assessment visits.
Who cannot join
- Treatment regarding the current LBP and/or sciatica (e.g. surgery, nerve block, or analgesic medication) other than the CAM treatment specified in the protocol
- Non-spinal or soft tissue problem related to back pain or sciatica (e.g. pregnancy, spinal tumor, or rheumatoid arthritis)
- History of spinal surgery, vertebral dislocation, fracture, or cancer;
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Spine and joint Research Institute
Seoul, 135-896
About this study
Official title: The Long-term Course of Patients Undergoing Alternative and Integrative Therapy for Lumbar Disk Herniation: A Prospective Observational Study
The investigators report management of lumbar disc herniation with severe sciatic pain using an integrative complementary and alternative medicine approach with a 5 year follow-up.
- Conditions
- Sciatica, Intervertebral Disc Disorder
- Being tested
- herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation
- Medical subject headings
- Sciatica, Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulationOther
| Study group | Role | What they receive |
|---|---|---|
| Lumbar disc herniation patients | LBP with sciatica, with a numeral rating scale (NRS) leg pain intensity of 5 or higher and onset within 1 year; (2) LDH confirmed by MRI Receives: Other: herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale for low back and leg pain
Measured: Changes from Baseline in Visual analogue scale at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
the Oswestry Disability Index
Measured: Changes from Baseline in the Oswestry Disability Index at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
the SF-36 Health Survey
Measured: Changes from Baseline in the SF-36 Health Survey at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
Secondary outcomes (2)
Straight Leg Raise test
Measured: Changes from Baseline in the Straight Leg Raise test at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
Adverse events
Skin and general reactions, aggravation or change in pain before and after acupuncture, pharmacoacupuncture, and Chuna manipulation treatment were observed.
Regular blood tests (blood cell count, liver, renal function tests, inflammatory activity indexes) were administered.
Measured: at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startFeb 2006
- Primary completionAug 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SciaticaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Jaseng Hospital of Korean Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989403
- Sponsor's protocol ID
- JS-CT-2011-03
- Status last verified
- Nov 2018
- First submitted
- 4 Nov 2013
- 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
- The Long-term Course of Patients Undergoing Alternative and Integrative Therapy for Lumbar Disk Herniation: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01989403
- Acronym / sponsor ID
- JS-CT-2011-03
- Conditions
- Sciatica, Intervertebral Disc Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Jaseng Hospital of Korean MedicineUniversity, hospital or other
- Study start
- Feb 2006 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Nov 2013 (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 investigators report management of lumbar disc herniation with severe sciatic pain using an integrative complementary and alternative medicine approach with a 5 year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar disc herniation patients | – | Other: herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulationLBP with sciatica, with a numeral rating scale (NRS) leg pain intensity of 5 or higher and onset within 1 year; (2) LDH confirmed by MRI |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- integrative hospital that offers both Western and traditional Korean medical services
Key inclusion criteria (5 listed)
- LBP with sciatica,
- A numeral rating scale (NRS) leg pain intensity of 5 or higher
- Onset within 1 year;
- Lumbar Disk Heriation confirmed by MRI;
- Written consent to attend 6 months of integrative CAM treatment and following assessment visits.
Key exclusion criteria (3 listed)
- Treatment regarding the current LBP and/or sciatica (e.g. surgery, nerve block, or analgesic medication) other than the CAM treatment specified in the protocol
- Non-spinal or soft tissue problem related to back pain or sciatica (e.g. pregnancy, spinal tumor, or rheumatoid arthritis)
- History of spinal surgery, vertebral dislocation, fracture, or cancer;
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 |
|---|---|---|
| herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation | Other | Lumbar disc herniation patients |
Primary outcome
Visual analogue scale for low back and leg pain
Time frame: Changes from Baseline in Visual analogue scale at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
the Oswestry Disability Index
Time frame: Changes from Baseline in the Oswestry Disability Index at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
the SF-36 Health Survey
Time frame: Changes from Baseline in the SF-36 Health Survey at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
2 secondary outcomes
Straight Leg Raise test
Time frame: Changes from Baseline in the Straight Leg Raise test at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
Adverse events
Time frame: at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sciatica and Intervertebral Disc Disorder, 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 5 inclusion and 3 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 for low back and leg pain (time frame: Changes from Baseline in Visual analogue scale at 2 weeks, 4 weeks, 8weeks, 12weeks, 20weeks, 24weeks, 1 years, 2years,3years,4years and 5years.). The study lists 3 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.