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

Withdrawn

• Conditions: Lumbar Disc Herniation; Gait Analysis; Manual Therapy
• Interventions: Procedure: Chuna manipulation; Drug: Herbal medicine; Procedure: Bee venom pharmacopuncture; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Other: Other intervention(s)

• Registration Number: NCT03858556
• Lead Sponsor: Jaseng Medical Foundation

Brief Summary

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 Timeline

• Study First Submitted: 2018-12-17
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-26
• Study Start: 2019-02-27
• Primary Completion: 2019-02-27
• Study Completion: 2019-02-27
• Study First Posted: 2019-02-28
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with lumbar disc herniation	Chuna manipulation	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)
Patients with lumbar disc herniation	Herbal medicine	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)
Patients with lumbar disc herniation	Bee venom pharmacopuncture	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)
Patients with lumbar disc herniation	Pharmacopuncture	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)
Patients with lumbar disc herniation	Acupuncture	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)
Patients with lumbar disc herniation	Electroacupuncture	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)
Patients with lumbar disc herniation	Cupping	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)
Patients with lumbar disc herniation	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)

Primary Outcome Measures

Name	Time	Method
Gait parameter change	baseline, 2 weeks after baseline	- Time parameters(step time)

Secondary Outcome Measures

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