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

NCT02975011 | Terminated

• 1 other identifier: JS-CT-2016-03
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Magnetic Resonance Imaging; Patient Satisfaction; Numeric Rating Scale

Outcome Measures

Primary Outcomes (2)

• Change in Numeric rating scale (NRS) of low back pain

  Change in low back pain intensity

  Change from baseline to 3 months

• Change in Numeric rating scale (NRS) of radiating leg pain

  Change in radiating leg pain intensity

  Change from baseline to 3 months

Secondary Outcomes (8)

• Numeric rating scale (NRS) of low back pain

  Baseline, 1, 2, 3, 6, 12 months

• Numeric rating scale (NRS) of radiating leg pain

  Baseline, 1, 2, 3, 6, 12 months

• Oswestry Disability Index (ODI)

  Baseline, 1, 2, 3, 6, 12 months

• EuroQol 5-dimensions 5-levels (EQ-5D-5L)

  Baseline, 1, 2, 3, 6, 12 months

• Patient Global Impression of Change (PGIC)

  6, 12 months

Study Arms (1)

Lumbar stenosis group

Lumbar stenosis patients will be administered integrative Korean medicine treatment consisting of herbal medicine, Chuna manipulation, bee venom pharmacopuncture and pharmacopuncture, acupuncture, electroacupuncture, cupping, and other interventions, as needed.

Drug: Herbal medicine; Procedure: Chuna manipulation; Procedure: Bee venom pharmacopuncture; Procedure: Pharmacopuncture; Procedure: Acupuncture; Procedure: Electroacupuncture; Procedure: Cupping; Other: Other intervention(s)

Interventions

Herbal medicine DRUG

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).

Also known as: Traditional herbal medicine

Lumbar stenosis group

Chuna manipulation PROCEDURE

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.

Also known as: Chuna spinal manipulation

Lumbar stenosis group

Bee venom pharmacopuncture PROCEDURE

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).

Also known as: Bee venom acupuncture

Lumbar stenosis group

Pharmacopuncture PROCEDURE

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).

Lumbar stenosis group

Acupuncture PROCEDURE

Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Lumbar stenosis group

Electroacupuncture PROCEDURE

Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.

Lumbar stenosis group

Cupping PROCEDURE

Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.

Lumbar stenosis group

Other intervention(s) OTHER

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.

Lumbar stenosis group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Lumbar stenosis patients with MRI results visiting and receiving treatment at 3 locations of Jaseng Hospital of Korean Medicine between November 2016 and March 2018

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Medical Foundation

Seoul, South Korea

Location

MeSH Terms

Conditions

Spinal Stenosis; Patient Satisfaction

Interventions

Phytotherapy; Acupuncture Therapy; Electroacupuncture; Cupping Therapy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Combined Modality Therapy; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Jinho Lee, KMD, Ph.D.

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical management director

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: November 29, 2016
• Study Start: March 4, 2017
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)