Lumbar Disc HerniationNCT03858556
Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation
An observational study of Lumbar Disc Herniation and Gait Analysis, run by Jaseng Medical Foundation.
Trial summary
Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Gait Analysis, Manual Therapy
- What is being tested?
- Chuna manipulation, Herbal medicine and Bee venom pharmacopuncture
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2019to 27 Feb 2019
- How long will I take part?
- 2 Weeks
- 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 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients who are admitted to Jaseng Hospital of Korean Medicine
Who may be able to join
- Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI
- Patients with radiculopathy
- Patients aged 19 to 60
- Patients with an Oswestry Disability Index (ODI) of ≥10
- Patients who have agreed to participate in the clinical study and given written informed consent
Who cannot join
- Patients who were unable to walk for more than 5 minutes due to pain
- Patients with a serious disease that may limit gait(such as spinal metastasis of the tumor, acute fracture and spinal dislocation)
- Patients with chronic conditions that may interfere with the interpretation of the therapeutic effect or outcome(such as chronic kidney failure)
- Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
- Patients with severe mental illness
- Patients who are currently on on steroids, immunosuppressants, psychiatric medications, or other medications that can affect outcome
- Patients who are pregnant or planning a pregnancy
- Patients who are participating in other clinical studies or if it is difficult for you to participate in clinical research as determined by the researcher
About this study
Official title: Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation
Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation
Read the detailed description
To investigate the effect of Chuna manual therapy on gate, 20 patients with lumbar disc herniation were studied. The gait analysis was performed before the first treatment, after the seventh treatment, after the 14th treatment, and compared with the data of 20 normal subjects.
- Conditions
- Lumbar Disc Herniation, Gait Analysis, Manual Therapy
- Being tested
- Chuna manipulation, Herbal medicine, Bee venom pharmacopuncture, Pharmacopuncture, Acupuncture
- Keywords
- gait, effectiveness, treatment, Lumbar intervertebral disc herniation, Chuna
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chuna manipulationProcedure or surgery
Also called Chuna spinal manipulation
Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
Herbal medicineDrug
Also called Traditional herbal medicine
Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
Bee venom pharmacopunctureProcedure or surgery
Also called Bee venom acupuncture
Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
PharmacopunctureProcedure or surgery
Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
AcupunctureProcedure or surgery
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
ElectroacupunctureProcedure or surgery
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
CuppingProcedure or surgery
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Other intervention(s)Other
Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with lumbar disc herniation | 3times(baseline, 1weeks, 2weeks) of Observation of gait, Oswestry disability index, EQ5D-5L, Lumbar Range of motion in inpatients with lumbar intervertebral disc herniation hospitalized at Korean medicine hospital.
-Integrative Korean medicine treatment Procedure/Surgery: Chuna manipulation Drug: Herbal medicine Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s) Other: Other intervention(s) Receives: Procedure: Chuna manipulation; Drug: Herbal medicine; Procedure: Bee venom pharmacopuncture; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Other: Other intervention(s) | |
| Normal | baseline Observation of gait, Oswestry disability index, EQ5D-5L, Lumbar Range of motion. -No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameter change
- Time parameters(step time)
Measured: baseline, 2 weeks after baseline
Secondary outcomes (4)
ODI
Oswestry Disability Index(ODI)
Measured: baseline, 2 weeks after baseline
EQ-5D
EuroQol-5 Dimension(EQ-5D)
Measured: baseline, 2 weeks after baseline
Lumbar ROM
Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation)
Measured: baseline, 2 weeks after baseline
SLR
Straight Leg Raise test(SLR)
Measured: baseline, 2 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start27 Feb 2019
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Why it stopped: Study plan was changed, this project would not be in progress
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858556
- Sponsor's protocol ID
- JS-CT-2018-08 Gait analysis
- Status last verified
- Feb 2019
- First submitted
- 17 Dec 2018
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT03858556
- Acronym / sponsor ID
- JS-CT-2018-08 Gait analysis
- Conditions
- Lumbar Disc Herniation, Gait Analysis, Manual Therapy
- Keywords
- gait, effectiveness, treatment, Lumbar intervertebral disc herniation, Chuna
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study plan was changed, this project would not be in progress
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 28 Feb 2019 (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.
Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation
Detailed description
To investigate the effect of Chuna manual therapy on gate, 20 patients with lumbar disc herniation were studied. The gait analysis was performed before the first treatment, after the seventh treatment, after the 14th treatment, and compared with the data of 20 normal subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with lumbar disc herniation | – | Procedure: Chuna manipulation, Drug: Herbal medicine, Procedure: Bee venom pharmacopuncture, Procedure: Pharmacopuncture, Procedure: Acupuncture, Procedure: Electroacupuncture, Procedure: Cupping, Other: Other intervention(s)3times(baseline, 1weeks, 2weeks) of Observation of gait, Oswestry disability index, EQ5D-5L, Lumbar Range of motion in inpatients with lumbar intervertebral disc herniation hospitalized at Korean medicine hospital. -Integrative Korean medicine treatment Procedure/Surgery: Chuna manipulation Drug: Herbal medicine Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s) Other: Other intervention(s) |
| Normal | – | –baseline Observation of gait, Oswestry disability index, EQ5D-5L, Lumbar Range of motion. -No treatment |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients who are admitted to Jaseng Hospital of Korean Medicine
Key inclusion criteria (5 listed)
- Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI
- Patients with radiculopathy
- Patients aged 19 to 60
- Patients with an Oswestry Disability Index (ODI) of ≥10
- Patients who have agreed to participate in the clinical study and given written informed consent
Key exclusion criteria (8 listed)
- Patients who were unable to walk for more than 5 minutes due to pain
- Patients with a serious disease that may limit gait(such as spinal metastasis of the tumor, acute fracture and spinal dislocation)
- Patients with chronic conditions that may interfere with the interpretation of the therapeutic effect or outcome(such as chronic kidney failure)
- Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
- Patients with severe mental illness
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 |
|---|---|---|
| Chuna manipulationAlso: Chuna spinal manipulationChuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion. | Procedure or surgery | Patients with lumbar disc herniation |
| Herbal medicineAlso: Traditional herbal medicineHerbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica). | Drug | Patients with lumbar disc herniation |
| Bee venom pharmacopunctureAlso: Bee venom acupunctureBee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea). | Procedure or surgery | Patients with lumbar disc herniation |
| PharmacopuncturePharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea). | Procedure or surgery | Patients with lumbar disc herniation |
| AcupunctureAcupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Patients with lumbar disc herniation |
| ElectroacupunctureElectroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Patients with lumbar disc herniation |
| CuppingCupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points. | Procedure or surgery | Patients with lumbar disc herniation |
| Other intervention(s)Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study. | Other | Patients with lumbar disc herniation |
Primary outcome
Gait parameter change
Time frame: baseline, 2 weeks after baseline
- Time parameters(step time)
4 secondary outcomes
ODI
Time frame: baseline, 2 weeks after baseline
EQ-5D
Time frame: baseline, 2 weeks after baseline
Lumbar ROM
Time frame: baseline, 2 weeks after baseline
SLR
Time frame: baseline, 2 weeks after baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation and Gait Analysis, run by Jaseng Medical Foundation.
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 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: withdrawn, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Gait parameter change (time frame: baseline, 2 weeks after baseline). 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 29 Mar 2019.