NCT03879447

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

Observational Study on the Effectiveness and Safety of Integrative Korean Medicine Treatment for Patients With Low Back Pain or Sciatica Due to Lumbar Stenosis or Spondylolisthesis

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Jaseng Medical Foundation · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in lumbar stenosis or spondylolisthesis patients with low back pain or sciatica at 3 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, walking ability, and quality of life patient-reported outcomes

Detailed description

This is a prospective observational study to the aim of investigating the effectiveness and safety of integrative Korean medicine treatment (generally consisting of herbal medicine, Chuna manual medicine, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, and cupping) in lumbar stenosis or spondylolisthesis patients with low back pain or sciatica diagnosed by lumbar X-ray and/or MRI and clinical symptoms including neurogenic claudication at 3 locations of Jaseng Hospital of Korean Medicine (Bucheon, Daejeon, Busan (Haeundae)) as assessed through of pain, functional disability, walking ability, and quality of life patient-reported outcomes with a 5-year follow-up period

Conditions

• Lumbar Spinal Stenosis
• Lumbar Spondylolisthesis
• Low Back Pain
• Sciatica
• Neurogenic Claudication

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) 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.

Timeline

• Start date: 2019-06-24
• Primary completion: 2022-03-03
• Completion: 2027-12-01
• First posted: 2019-03-18
• Last updated: 2025-12-23

Locations

1 site across 1 country: South Korea