Tension Headache Clinical Trial
Official title:
The Effectiveness and Safety of Pharmacopuncture on Inpatients With Tension Headache Caused by Traffic Accidents: A Pragmatic Randomized Controlled Trial
Verified date | October 2023 |
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 tension headache treatment/intervention: Pharmacopuncture
Status | Completed |
Enrollment | 80 |
Est. completion date | April 4, 2023 |
Est. primary completion date | April 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 69 Years |
Eligibility | Inclusion Criteria: - Patients who needs hospitalization due to acute tension headache that occurred within 7 days after traffic accident - Patients with NRS = 5 for headache - Patients aged 19-69 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 headache: malignancy, cerebral hemorrhage, dural hematoma, 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 nerve system disease: trigeminal neuralgia, glossopharyngeal neuralgia, 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 pharmacopuncture and 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 |
Lead Sponsor | Collaborator |
---|---|
Jaseng Medical Foundation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numeric Rating Scale(NRS) of headache | The extent of headache and discomfort will be assessed by 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 headache and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. | Change from baseline NRS at 4 days | |
Secondary | Numeric Rating Scale(NRS) of Neck pain | 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 leg pain and discomfort using NRS, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'. | Baseline(day2), day3, day4, day of discharge(up to 14days), week 8 | |
Secondary | Headache Disability Index(HDI) | The HDI is a 25-item, self-report headache disability measure that has good internal consistency reliability and strong long-term test-retest stability. | Baseline(day2), day4, day of discharge(up to 14days), week 8 | |
Secondary | Headache Impact Test-6(HIT-6) | The HIT-6 items measure the adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological distress. The HIT-6 also measures the severity of headache pain. | Baseline(day2), day4, day of discharge(up to 14days), week 8 | |
Secondary | EuroQol 5-Dimension 5-Level (EQ-5D-5L) | 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, the investigators will use the Korean version of the EQ-5D, which has been demonstrated to be valid. | Baseline(day2), day4, day of discharge(up to 14days), week 8 | |
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. | day4, day of discharge(up to 14days), week 8 |
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