Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/spondylolisthesis

Active, not recruitingOBSERVATIONAL
Enrollment

110

Participants

Timeline

Start Date

June 24, 2019

Primary Completion Date

March 3, 2022

Study Completion Date

December 31, 2027

Conditions
Lumbar Spinal StenosisLumbar SpondylolisthesisLow Back PainSciaticaNeurogenic Claudication
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) at the physician's discretion.

PROCEDURE

Chuna manual medicine

Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine 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 manual medicine will be administered to the 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 usually 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) at the physician's discretion.

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.

PROCEDURE

Other intervention(s)

Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.

Trial Locations (1)

Unknown

Jaseng Medical Foundation, Seoul

Sponsors
All Listed Sponsors
lead

Jaseng Medical Foundation

OTHER

NCT03879447 - Effectiveness and Safety of Korean Medicine for Low Back Pain or Sciatica Due to Lumbar Stenosis/spondylolisthesis | Biotech Hunter | Biotech Hunter