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

Lumbar Disc Herniation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03858556
• Other study ID #: JS-CT-2018-08 Gait analysis
• Status: Withdrawn
• Start date: February 27, 2019
• Est. completion date: February 27, 2019

Study information

• Verified date: February 2019
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 27, 2019
• Est. primary completion date: February 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Analysis
• Hernia
• Lumbar Disc Herniation
• Manual Therapy

Intervention

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.

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).

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait parameter change	- Time parameters(step time)	baseline, 2 weeks after baseline
Secondary	ODI	Oswestry Disability Index(ODI)	baseline, 2 weeks after baseline
Secondary	EQ-5D	EuroQol-5 Dimension(EQ-5D)	baseline, 2 weeks after baseline
Secondary	Lumbar ROM	Lumbar Range of Motion(ROM) (Flexion/Extension/Lateral flexion/Rotation)	baseline, 2 weeks after baseline
Secondary	SLR	Straight Leg Raise test(SLR)	baseline, 2 weeks after baseline