NCT02975011

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

Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients With Sciatica Due to Lumbar Stenosis: Multicenter, Prospective, Single Group Observational Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: Jaseng Medical Foundation · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a prospective study to the aim of investigating the effectiveness and safety in patients with neurogenic claudication diagnosed as lumbar stenosis by lumbar MRI and receiving integrative Korean medicine treatment (herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) through assessment of pain, functional disability, and quality of life with 1-year follow-up period

Conditions

• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-04
• Primary completion: 2018-11-02
• Completion: 2018-11-02
• First posted: 2016-11-29
• Last updated: 2018-11-07

Locations

1 site across 1 country: South Korea