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

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02975011
• Other study ID #: JS-CT-2016-03
• Status: Terminated
• Start date: March 4, 2017
• Est. completion date: November 2, 2018

Study information

• Verified date: November 2018
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: November 2, 2018
• Est. primary completion date: November 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with radiating leg pain with or without low back pain (LBP) (walking pain NRS =4)

• Patients with dural sac cross-sectional area (DSCA) of <100 mm2 or morphological grading =B as assessed on MRI

• Patients with clear neurogenic claudication symptoms (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position)

• Patients who have received surgery recommendation for lumbar spinal stenosis

• Patients with plans of receiving Korean medicine treatment for lumbar spinal stenosis for =2 months

• Patients who have agreed to study participation

Exclusion Criteria:

• Patients with vascular claudication

• Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation

• Patients with soft tissue pathologies or pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, rheumatoid arthritis)

• Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection, severe cardiovascular diseases, or other conditions deemed unsuitable for acupuncture treatment)

• Pregnant patients or patients planning pregnancy

• Patients with serious psychological disorders

• Patients unable to fill out study participation consent form

• Subjects deemed unsuitable for study participation as assessed by the researchers

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Sciatica
• Spinal Stenosis

Intervention

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.
• 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
Korea, Republic of	Jaseng Medical Foundation	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Numeric rating scale (NRS) of low back pain	Change in low back pain intensity	Change from baseline to 3 months
Primary	Change in Numeric rating scale (NRS) of radiating leg pain	Change in radiating leg pain intensity	Change from baseline to 3 months
Secondary	Numeric rating scale (NRS) of low back pain	Low back pain intensity for the past 3 days	Baseline, 1, 2, 3, 6, 12 months
Secondary	Numeric rating scale (NRS) of radiating leg pain	Radiating leg pain intensity for the past 3 days	Baseline, 1, 2, 3, 6, 12 months
Secondary	Oswestry Disability Index (ODI)	Functional disability questionnaire	Baseline, 1, 2, 3, 6, 12 months
Secondary	EuroQol 5-dimensions 5-levels (EQ-5D-5L)	Health-related quality of life questionnaire	Baseline, 1, 2, 3, 6, 12 months
Secondary	Patient Global Impression of Change (PGIC)	Global patient-reported outcome	6, 12 months
Secondary	Current medical service use	Current use of medical services (type, frequency, period)	Baseline, 1, 2, 3, 6, 12 months
Secondary	Pain-free walking time	Average pain-free walking time for the past 3 days	Baseline, 1, 2, 3, 6, 12 months
Secondary	Physical examination	Lumbar physical examination	Baseline, 1, 2, 3 months