Effectiveness and Safety of Korean Medicine for Lumbar Stenosis Patients With Sciatica

NCT02975011 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2018-11-07

No results posted yet for this study

Summary

A prospective study investigating the effectiveness and safety in lumbar stenosis patients receiving integrative Korean medicine treatment at 3 locations of Jaseng Hospital of Korean Medicine through assessment of pain, functional disability, and quality of life

Conditions

  • Lumbar Spinal Stenosis

Interventions

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

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.

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).

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.

Sponsors & Collaborators

  • Jaseng Medical Foundation

    lead OTHER

Principal Investigators

  • Jinho Lee, KMD, Ph.D. · Jaseng Medical Foundation

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-04
Primary Completion
2018-11-02
Completion
2018-11-02

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02975011 on ClinicalTrials.gov