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

Sponsor

Jaseng Medical Foundation (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03858556

Collaborator

(none)

Enrollment

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

0 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 27, 2019

Actual Primary Completion Date :

Feb 27, 2019

Actual Study Completion Date :

Feb 27, 2019

Arms and Interventions

Arm	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 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: 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: 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

Arm

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 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: 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: 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

Outcome Measures

Primary Outcome Measures

Gait parameter change [baseline, 2 weeks after baseline]
- Time parameters(step time)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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