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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858556
Recruitment Status : Withdrawn (Study plan was changed, this project would not be in progress)
First Posted : February 28, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
In-Hyuk Ha, KMD, Jaseng Medical Foundation

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

Condition or disease Intervention/treatment
Lumbar Disc Herniation Gait Analysis Manual Therapy Procedure: Chuna manipulation Drug: Herbal medicine Procedure: Bee venom pharmacopuncture Procedure: Pharmacopuncture Procedure: Acupuncture Procedure: Electroacupuncture Procedure: Cupping Other: Other intervention(s)

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Prospective Observation Study of the Effect of Chuna Manipulation Therapy on Gait in Patients With Lumbar Disc Herniation
Actual Study Start Date : February 27, 2019
Actual Primary Completion Date : February 27, 2019
Actual Study Completion Date : February 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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: 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 Name: 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 Name: Traditional herbal medicine

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 Name: Bee venom acupuncture

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).

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.

Normal

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

-No treatment




Primary Outcome Measures :
  1. Gait parameter change [ Time Frame: baseline, 2 weeks after baseline ]
    - Time parameters(step time)


Secondary Outcome Measures :
  1. ODI [ Time Frame: baseline, 2 weeks after baseline ]
    Oswestry Disability Index(ODI)

  2. EQ-5D [ Time Frame: baseline, 2 weeks after baseline ]
    EuroQol-5 Dimension(EQ-5D)

  3. Lumbar ROM [ Time Frame: baseline, 2 weeks after baseline ]
    Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation)

  4. SLR [ Time Frame: baseline, 2 weeks after baseline ]
    Straight Leg Raise test(SLR)



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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who are admitted to Jaseng Hospital of Korean Medicine
Criteria

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
Additional Information:

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Responsible Party: In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
ClinicalTrials.gov Identifier: NCT03858556    
Other Study ID Numbers: JS-CT-2018-08 Gait analysis
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by In-Hyuk Ha, KMD, Jaseng Medical Foundation:
gait
effectiveness
treatment
Lumbar intervertebral disc herniation
Chuna
Additional relevant MeSH terms:
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Hernia
Pathological Conditions, Anatomical