Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation

March 27, 2019 updated by: In-Hyuk Ha, KMD, Jaseng Medical Foundation

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who are admitted to Jaseng Hospital of Korean Medicine

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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: Acupuncture
Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Procedure: Electroacupuncture
Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
Procedure: Cupping
Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
Other: 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.
Procedure: Bee venom pharmacopuncture
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).
Other Names:
  • Bee venom acupuncture
Procedure: Chuna 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.
Other Names:
  • Chuna spinal manipulation
Drug: 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).
Other Names:
  • Traditional herbal medicine
Procedure: Pharmacopuncture
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).
Normal

baseline Observation of gait, Oswestry disability index, EQ5D-5L, Lumbar Range of motion.

-No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait parameter change
Time Frame: baseline, 2 weeks after baseline
- Time parameters(step time)
baseline, 2 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ODI
Time Frame: baseline, 2 weeks after baseline
Oswestry Disability Index(ODI)
baseline, 2 weeks after baseline
EQ-5D
Time Frame: baseline, 2 weeks after baseline
EuroQol-5 Dimension(EQ-5D)
baseline, 2 weeks after baseline
Lumbar ROM
Time Frame: baseline, 2 weeks after baseline
Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation)
baseline, 2 weeks after baseline
SLR
Time Frame: baseline, 2 weeks after baseline
Straight Leg Raise test(SLR)
baseline, 2 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaseng Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 27, 2019

Primary Completion (ACTUAL)

February 27, 2019

Study Completion (ACTUAL)

February 27, 2019

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

February 26, 2019

First Posted (ACTUAL)

February 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-CT-2018-08 Gait analysis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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