Clinical trial NCT03959098: Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation
Official title: Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Cervical Disc Herniation with Radiculopathy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neck Pain
Cervical Radiculopathy
Intervertebral Disc Displacement
Keywords: Korean Medicine
Effectiveness
Neck Pain
Lead sponsor: Jaseng Medical Foundation
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptoms of neck pain or radiating arm pain alongside cervical radiculopathy symptoms

Brief summary: A prospective observational study investigating the effectiveness and safety of integrative Korean medicine treatment in cervical disc herniation patients with neck pain or cervical radiculopathy at 4 locations of Jaseng Hospital of Korean Medicine as assessed through of pain, functional disability, work loss 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 cervical disc herniation patients with neck pain or cervical radiculitis diagnosed by cervical MRI and clinical symptoms including cervical radiculopathy at 4 locations of Jaseng Hospital of Korean Medicine (Gangnam, Bucheon, Daejeon, Haeundae) as assessed through of pain, functional disability, work loss, and quality of life patient-reported outcomes with a 5-year follow-up period

Eligibility criteria: Inclusion Criteria:

* Patients with age between 19 years \~ 65 years
* Patients with one arm pain or both side arm pain or neck pain with intensity of NRS ≥6 which occurred less then 12 month before
* Patients with cervical radiculopathy symptoms of one or both side of arms
* Patients diagnosed with cervical disc herniation with over protrusion degree of prolapsed inter-vertebral disc assessed on MRI
* Patients with plans of receiving Korean medicine treatment for cervical disc herniation for ≥2 months
* Patients who have agreed to study participation

Exclusion Criteria:

* 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 neck pain or radiating arm pain (e.g. spinal tumor, rheumatoid arthritis)
* Patients with medical history of cervical myelopathy which can cause neck pain or radiating arm pain
* Patients with medical history of surgery in relation with cervical disc herniation
* Patients for whom acupuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anticoagulation 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
* Patients deemed unsuitable for study participation as assessed by the researchers

Primary outcomes:
measure: Change in Numeric rating scale (NRS) out of neck pain and radiating arm pain
timeFrame: Time Frame: Change from baseline to 4 months
Secondary outcomes:
measure: Visual analogue scale (VAS) of neck pain
timeFrame: Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Visual analogue scale (VAS) of radiating arm pain
timeFrame: Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Neck Disability Index (NDI)
timeFrame: Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Patient Global Impression of Change (PGIC)
timeFrame: Time Frame: 8, 16, 20, 24 weeks, 1, 3, 5 years
measure: EuroQol 5-dimensions 5-levels (EQ-5D-5L)
timeFrame: Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Type and frequency of other intervention(s)
timeFrame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Physical examination
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Type and frequency of adverse reaction(s)
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Numeric rating scale (NRS) of Neck pain
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: Numeric rating scale (NRS) of radiating arm pain
timeFrame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: SF-36
timeFrame: Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
measure: EQ-VAS
timeFrame: [Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Medical Foundation
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Won-Il Ko, KMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daejeon Jaseng Hospital of Korean Medicine
name: Sun-A Kim, KMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haeundae Jaseng Hospital of Korean Medicine
name: Hyun-Woo Cho, KMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bucheon Jaseng Hospital of Korean Medicine
name: Ji-Yun Seo, KMD
role: PRINCIPAL_INVESTIGATOR
References: