NCT03858556

Brief Summary

Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2019

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

February 27, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
Last Updated

March 29, 2019

Status Verified

February 1, 2019

Enrollment Period

Same day

First QC Date

December 17, 2018

Last Update Submit

March 27, 2019

Conditions

Lumbar Disc HerniationGait AnalysisManual Therapy

Keywords

gaiteffectivenesstreatmentLumbar intervertebral disc herniationChuna

Outcome Measures

Primary Outcomes (1)

  • Gait parameter change

    \- Time parameters(step time)

    baseline, 2 weeks after baseline

Secondary Outcomes (4)

  • ODI

    baseline, 2 weeks after baseline

  • EQ-5D

    baseline, 2 weeks after baseline

  • Lumbar ROM

    baseline, 2 weeks after baseline

  • SLR

    baseline, 2 weeks after baseline

Study Arms (2)

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)

Procedure: Chuna manipulationDrug: Herbal medicineProcedure: Bee venom pharmacopunctureProcedure: PharmacopunctureProcedure: AcupunctureProcedure: ElectroacupunctureProcedure: CuppingOther: Other intervention(s)

Normal

baseline Observation of gait, Oswestry disability index, EQ5D-5L, Lumbar Range of motion. -No treatment

Interventions

Chuna manipulationPROCEDURE

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.

Also known as: Chuna spinal manipulation
Patients with lumbar disc herniation
Herbal medicineDRUG

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).

Also known as: Traditional herbal medicine
Patients with lumbar disc herniation
Bee venom pharmacopuncturePROCEDURE

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).

Also known as: Bee venom acupuncture
Patients with lumbar disc herniation
PharmacopuncturePROCEDURE

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).

Patients with lumbar disc herniation
AcupuncturePROCEDURE

Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Patients with lumbar disc herniation
ElectroacupuncturePROCEDURE

Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Patients with lumbar disc herniation
CuppingPROCEDURE

Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.

Patients with lumbar disc herniation
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.

Patients with lumbar disc herniation

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who are admitted to Jaseng Hospital of Korean Medicine

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

PhytotherapyAcupuncture TherapyElectroacupunctureCupping Therapy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsCombined Modality TherapyElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 17, 2018

First Posted

February 28, 2019

Study Start

February 27, 2019

Primary Completion

February 27, 2019

Study Completion

February 27, 2019

Last Updated

March 29, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share