Neck Pain Clinical Trial
Official title:
Observational Study on Effectiveness and Safety of Integrative Korean Medicine Treatment for Cervical Disc Herniation With Radiculopathy
Verified date | October 2023 |
Source | Jaseng Medical Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jaseng Medical Foundation | Seoul |
Lead Sponsor | Collaborator |
---|---|
Jaseng Medical Foundation |
Korea, Republic of,
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] |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05293847 -
Postural Based Telerehabilitation in Mechanic Neck Pain
|
N/A | |
Completed |
NCT04060004 -
The Effects of Dry Needling on the Superficial Neck Musculature
|
N/A | |
Recruiting |
NCT06204627 -
TDCS* and Laterality Trainnning in Patients With Chronic Neck Pain
|
N/A | |
Active, not recruiting |
NCT05870371 -
The Effect of the Feldenkrais Method on Pain and Function in Patients With Chronic Neck Pain
|
N/A | |
Completed |
NCT06049316 -
Scapular Stabilization vs Functional Exercises on Chronic Neck Pain
|
N/A | |
Recruiting |
NCT05944354 -
Wearable Spine Health System for Military Readiness
|
||
Completed |
NCT03147508 -
Investigating Clinical Indicators of Spine Related Dysfunction Patterns. A Clinical Study on Neck Pain Patients.
|
||
Completed |
NCT02882061 -
Examination of Cervical Thoracic Differentiation Testing in Individuals With Neck Pain
|
N/A | |
Completed |
NCT02731014 -
Dry Needling for Patients With Neck Pain
|
N/A | |
Completed |
NCT02904668 -
Self-management Program in Chronic Neck Pain
|
N/A | |
Completed |
NCT02638987 -
EMG Activity Before, During and After Dry Needling
|
N/A | |
Active, not recruiting |
NCT02843269 -
Multiple-component Workplace FRamed Intervention to Decrease Occupational Muscle Pain - FRIDOM
|
N/A | |
Enrolling by invitation |
NCT02485795 -
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
|
N/A | |
Completed |
NCT02235207 -
Effectiveness of Fustra—Exercise Program in Neck and Low Back Pain
|
N/A | |
Completed |
NCT02245425 -
Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
|
N/A | |
Completed |
NCT02225873 -
The Effectiveness of Exercises Protocol in Management of Neck Pain
|
N/A | |
Completed |
NCT02190890 -
Dry Needling Dosage in the Treatment of Myofascial Neck Pain
|
N/A | |
Completed |
NCT02051478 -
Thoracic Manipulation and Mobilization for Neck Pain
|
N/A | |
Completed |
NCT01938209 -
A Comparison of Seated Thoracic Manipulation and Targeted Supine Thoracic Manipulation on Cervical Flexion Motion and Pain
|
N/A | |
Completed |
NCT01233180 -
Effects of Gua Sha and Thermotherapy on Chronic Neck Pain
|
N/A |