Neck Pain, Posterior Clinical Trial
Official title:
The Efficacy and Safety of Trapezius MSAT on Inpatients With Acute Whiplash Injury Caused by Traffic Accidents: A Randomized Controlled Trials
Verified date | March 2020 |
Source | Jaseng Medical Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a double blind, randomized controlled trail. condition/disease: acute neck pain treatment/intervention: motion style acupuncture treatment
Status | Completed |
Enrollment | 100 |
Est. completion date | December 15, 2019 |
Est. primary completion date | September 7, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Patients who needs hospitalization due to acute whiplash injury that occurred within 7 days after traffic accident - Patients with NRS = 5 for posterior neck pain - Patients aged 19-70 years on the date they sign the consent form - Patients who provide consent to participate in the trial and return the informed consent form Exclusion Criteria: - Patients with a specific serious disease that may cause spinal pain: malignancy, spondylitis, inflammatory spondylitis, etc. - Patients with progressive neurological deficits or with severe neurological symptoms - Patients who have had surgery or procedures within the last three weeks - The cause of pain is due to soft tissue disease, not the spine: tumors, fibromyalgia, rheumatoid arthritis, gout, etc. - Patients with other chronic conditions that may interfere with the interpretation of the therapeutic effects or results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc. - Patients who are taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect the results of the study - If acupuncture is inadequate or unsafe: patients with hemorrhagic, receiving anticoagulants, severe diabetes and cardiovascular disease - Patients who are pregnant or planning to become pregnant - Patients with a serious mental illness - Patients who are participated in clinical trials other than observational studies without therapeutic intervention. - Patients who are difficult to complete the research participation agreement - Other patients whose participation in the trial is judged by a researcher to be problematic |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Jaseng Hospital of Korean Medicine | Seoul | Gangnam-Gu |
Korea, Republic of | Jaseng Medical Foundation | Seoul |
Lead Sponsor | Collaborator |
---|---|
Jaseng Medical Foundation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric Rating Scale(NRS) of neck pain | The extent of posterior neck pain and discomfort was assessed using NRS. NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. The participant is asked to report their posterior neck pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. | day 5 | |
Secondary | Visual Analogue Scale (VAS) of neck pain | VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end. | day 5 | |
Secondary | Visual Analogue Scale (VAS) of arm pain | VAS is an assessment index in which the patient records their pain on a 100mm line from 'no pain' at one end, and 'the most severe pain imaginable' at the other end. | day 5 | |
Secondary | Numeric Rating Scale(NRS) of arm pain | NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10. | day 5 | |
Secondary | Physical examination (Cervical range of motion) | ROM of flexion, extension, lateral flexion, rotation was measured. | day 5 | |
Secondary | Neck Disability Index (NDI) | The Neck Disability Index (NDI) is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. | day 5 | |
Secondary | EuroQol 5-Dimension (EQ-5D) | The EQ-5D is a method of indirectly calculating the weights of certain health states for quality of life after a multidimensional investigation of health states, and is the most widely used instrument for this purpose. The EQ-5D consists of 5 questions about current health state (mobility, self-care, usual activities, pain, anxiety/depression), and each question is scored on a 5-point Likert scale (1=no problems, 3=moderate problems, 5=severe problems). In this study, we will use the Korean version of the EQ-5D, which has been demonstrated to be valid. | day 5 | |
Secondary | Patient Global Impression of Change (PGIC) | The PGIC is an index that assesses improvements in functional limitation caused by whiplash injury. Participants rate the improvement in functional limitations after treatment on a 7-point Likert scale (1=Very much improved, 4=No change, 7=Very much worse). This index was originally developed for use in Psychology, but is currently used in various other medical fields to assess improvements in pain. | day 5 | |
Secondary | Drug Consumption | Check drug consumption change every visit | day 5 | |
Secondary | Adverse events | Check adverse events every visit | day 5 |
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