Effectiveness and Safety of Korean Medicine Treatment for Cervical Disc Herniation

Neck Pain Clinical Trial

Official title:

Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Cervical Disc Herniation With Radiculopathy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03959098
• Other study ID #: JS-CT-2019-02
• Status: Active, not recruiting
• Start date: June 24, 2019
• Est. completion date: December 1, 2027

Study information

• Verified date: October 2023
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 1, 2027
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Intervertebral Disc Displacement
• Neck Pain
• Radiculopathy

Intervention

Drug:
• Herbal medicine
Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum,Eucommia ulmoides, canthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, aposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycinemax, 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 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 manual medicine will be administered to the 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 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, hinchang medical co., Korea).
• Pharmacopuncture
Pharmacopuncture consisting of select herbal ingredients will be dministered 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.
• 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 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.

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) out of neck pain and radiating arm pain	Change from higher score at baseline out of neck pain or radiating arm pain intensity to same score at 4 months. Total score range: -10 (worse outcome) to 10 (better outcome) Total score range: -10 (worse outcome) to 10 (better outcome)	Time Frame: Change from baseline to 4 months
Secondary	Visual analogue scale (VAS) of neck pain	Neck pain intensity for the past 3 days. Total score range: 0 (better outcome) to 100 (worse outcome)	Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	Visual analogue scale (VAS) of radiating arm pain	Radiating arm pain intensity for the past 3 days. Total score range: 0 (better outcome) to 100 (worse outcome)	Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	Neck Disability Index (NDI)	Functional disability questionnaire. The possible range of each item score is 0 to 5. Total score range: 0 (better outcome) to 50 (worse outcome)	Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	Patient Global Impression of Change (PGIC)	Global patient-reported outcome. Total score range: 1 (better outcome) to 7 (worse outcome)	Time Frame: 8, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	EuroQol 5-dimensions 5-levels (EQ-5D-5L)	Health-related quality of life questionnaire. Total score range: 11111 (better outcome) to 55555 (worse outcome)	Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	Type and frequency of other intervention(s)	Use of any other additional intervention(s) other than the integrative Korean medicine treatment administered by the attending physician (start date of treatment, end date of treatment, name of treatment, number of treatment sessions received, and other comments)	Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	Physical examination	Cervical physical examination	Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	Type and frequency of adverse reaction(s)	Safety	Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	Numeric rating scale (NRS) of Neck pain	Neck pain intensity for the past 3 days. Total score range: 0 (better outcome) to 10 (worse outcome)	Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	Numeric rating scale (NRS) of radiating arm pain	Radiating arm pain intensity for the past 3 days. Total score range: 0 (better outcome) to 10 (worse outcome)	Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	SF-36	The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	Baseline, 4, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years
Secondary	EQ-VAS	The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.	[Time Frame: Baseline, 2, 4, 6, 8, 12, 16, 20, 24 weeks, 1, 3, 5 years]