Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Inpatients With Sciatica Due to Lumbar Intervertebral Disc Herniation

NCT03750591 | Completed

• 1 other identifier: JS-CT-2017-05-1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 4

Brief Summary

Observational study on the effectiveness and safety of integrative Korean medicine treatment for inpatients with sciatica due to lumbar intervertebral disc herniation

Conditions

Sciatica Due to Intervertebral Disc Disorder; Intervertebral Disc Displacement; Sciatica; Sciatic Radiculopathy

Keywords

Integrative Korean medicine; treatment; effectiveness; safety; Lumbar intervertebral disc herniation

Outcome Measures

Primary Outcomes (3)

• NRS change from Baseline NRS at discharge

  Numeric rating scale (NRS) of low back pain, and radiating leg pain In pain measurement using NRS, patients are asked to rate their pain by selecting a number from 0 to 10 that best represents their pain severity between the anchors of 0 which indicates 'no pain', and 10 which indicates 'worst pain possible'.

  Baseline (admission), discharge (up to 14 weeks after baseline)

• ODI change from Baseline ODI at discharge

  Oswestry Disability Index(ODI) The ODI evaluates functional impairment and is a 10-item questionnaire developed to assess the level of disability due to back pain. Each item is graded into 6 levels, each representing a score of 0-5. Higher scores indicate greater limitation relating to back pain.

  Baseline (admission), discharge (up to 14 weeks after baseline)

• PGIC

  Patient global impression of change (PGIC) PGIC grades the level of subjective improvement into 7 levels (1, very much improved; 2, much improved; 3, slightly improved; 4, no change; 5, slightly worse; 6, much worse; and 7, very much worse).

  6 months after baseline

Secondary Outcomes (6)

• EQ-5D change from Baseline EQ-5D at each time point

  Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline), 6 months after baseline

• Lumbar ROM from Baseline Lumbar ROM at each time point

  Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)

• SLR from Baseline SLR at each time point

  Baseline (admission), 2 weeks after baseline, discharge (up to 14 weeks after baseline)

• AE

  up to 14 weeks after baseline

• NRS change from Baseline NRS at each timepoint

  Baseline (admission), 2 weeks after baseline, 6 months after baseline

Study Arms (1)

Integrative Korean medicine treatment group

Observation of pain, function, quality of life, satisfaction, and adverse events in inpatients with lumbar intervertebral disc herniation hospitalized at 4 Korean medicine hospitals Interventions: Drug: Herbal medicine Procedure/Surgery: Chuna manual therapy Procedure/Surgery: Bee venom pharmacopuncture Procedure/Surgery: Pharmacopuncture Procedure/Surgery: Acupuncture Procedure/Surgery: Electroacupuncture Procedure/Surgery: Cupping Other intervention(s)

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

Interventions

Herbal medicine DRUG

Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: 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

Integrative Korean medicine treatment group

Chuna manual therapy PROCEDURE

Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving highvelocity, 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 at the physician's discretion.

Also known as: Chuna manipulation, Chuna spinal manipulation

Integrative Korean medicine treatment 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, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).

Also known as: Bee venom acupuncture

Integrative Korean medicine treatment group

Pharmacopuncture PROCEDURE

Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).

Integrative Korean medicine treatment group

Acupuncture PROCEDURE

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

Integrative Korean medicine treatment group

Electroacupuncture PROCEDURE

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

Integrative Korean medicine treatment group

Cupping PROCEDURE

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

Integrative Korean medicine treatment 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.

Integrative Korean medicine treatment group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are admitted or scheduled to be admitted to Jaseng Hospital of Korean Medicine, Bucheon Jaseng Hospital of Korean Medicine, Daejeon Jaseng Hospital of Korean Medicine, or Haeundae Jaseng Hospital of Korean Medicine

You may qualify if:

• Lumbar intervertebral disc herniation as confirmed by a doctor of medicine or a doctor of Korean medicine through an MRI taken within 3 years
• Patients with radiculopathy (ipsilateral or bilateral radiculopathy)
• Patients whose pain intensity of back pain or radiating leg pain is NRS≥5
• Patients aged 19 to 70
• Patients who have agreed to participate in the clinical study and given written informed consent
• Patients admitted to a Korean medicine hospital for treatment

You may not qualify if:

• Patients who have been diagnosed with a serious disease that may cause low back pain or neck pain (e.g. spinal metastasis of tumor, acute fracture, spinal dislocation)
• Patients admitted due to pain caused by traffic accidents
• Patients with progressive neurological deficit or severe neurological symptoms such as spinal cord injury
• Patients with severe mental illness
• Patients with difficulty or refusal to give sign written informed consent
• Patients for whom the researchers judge participation in the clinical study to be difficult
• Diagnosis of lumbar spondylolisthesis of Meyerding Ⅱ or higher by a doctor of medicine or doctor of Korean medicine through X-ray or MRI

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (4)

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, 48102, South Korea

Location

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, 35262, South Korea

Location

Jaseng Hospital of Korean Medicine

Seoul, 06110, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Sciatica

Interventions

Phytotherapy; Acupuncture Therapy; Electroacupuncture; Cupping Therapy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms

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

• HYUN WOO CHO, PhD

  Haeundae Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 23, 2018
• Study Start: March 31, 2018
• Primary Completion: May 10, 2019
• Study Completion: November 8, 2019
• Last Updated: March 13, 2020

Record last verified: 2020-03

Locations

KR (4)