Migraine Disorders Clinical Trial
Official title:
How Pain Resilience Determines the Efficacy of Holistic Health Care of Patients With Migraine
The purpose of this study is to investigate how pain resilience (as a personality characteristic or a strength) moderate the efficacy of treatment for patients with migraine. The primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs. The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life, less disability (assessed with the Migraine Disability Assessment Test, MIDAS), less frequency and lower severity of pain, and higher heart-rate variability after training. A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies.
Introduction：A multi-national research that included data from Taiwan found that chronic headache is one of the top two disorders (alongside with chronic low back pain) with the most patients having longest years of living with disabilities through year 1999 to 2017. It does not only impact a sufferer's ability to work, but also limit one's participation in a variety of daily housework, leisure activities, etc. Quality of life is also impacted. According to a systematic review on behavioral interventions for migraine, cognitive behavioral therapy (CBT) is one of the most common non-pharmacological practices implemented and studied. CBT has been found to be effective in reducing the intensity and frequency of headache, compared to waitlist controls. Another commonly discussed non-pharmacological treatment for migraine is exercise therapy. In regard to the controversial findings from therapeutic clinical trials, the unsolved puzzle is: why do some show improvements while the others remained unchanged or worse? It is found that psychological resilience for pain can be a determining factor in task persistence despite the interruption of pain. Pain resilience specifically refers to the cognitive and behavioral aspects of an individual when one is trying to deal with pain. In a study investigating negative pain beliefs (i.e. fear avoidance and pain catastrophizing) and pain outcomes (functional and movement aspects), pain resilience was found to moderate the relationship between pain beliefs and pain outcomes. The authors found that only in individuals with low level of pain resilience was the negative pain beliefs related to greater movement-relate pain. Since pain resilience is such an important capacity/ dynamic process in coping with chronic pain, the current study aims at investigating how pain resilience can be a moderating factor determining the outcome of pain management in patients with migraine. Objectives：The primary objective of the current study is to explore the moderation effect of pain resilience between initial pain and the treatment outcome of the holistic healthcare programs. The investigators hypothesize that participants with higher level of pain resilience will show more improvements in the quality of life, less disability (assessed with MIDAS), less frequency and lower severity of pain, and higher heart-rate variability after training. A secondary finding that can be obtained through the study is the comparison between the enhancement of heart rate variability in participants receiving different kinds of non-pharmacological therapies. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01432379 -
BOTOX® Prophylaxis in Patients With Chronic Migraine
|
||
| Completed |
NCT04084314 -
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
|
Phase 4 | |
| Recruiting |
NCT05048914 -
Migraine Abortive Treatment
|
||
| Completed |
NCT03662295 -
Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
|
||
| Completed |
NCT02766517 -
Biomarker Study in Participants With Migraine
|
Early Phase 1 | |
| Completed |
NCT00963937 -
Study to Evaluate the Efficacy and Safety of Oral Sumatriptan for the Acute Treatment of Migraine in Children and Adolescents
|
Phase 3 | |
| Not yet recruiting |
NCT03632928 -
Day to Day Variation of Pressure Pain Threshold and Muscle Hardness
|
||
| Completed |
NCT02559895 -
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
|
Phase 3 | |
| Completed |
NCT01435941 -
Non-steroidal Anti-inflammatory Drugs Alone or With a Triptan and Reports of Transition From Episodic to Chronic Migraine
|
N/A | |
| Completed |
NCT00743015 -
Relative Bioavailability of a Single Dose of BI 44370 Tablet During and Between Migraine Attacks
|
Phase 1 | |
| Completed |
NCT01376141 -
Drug Use Investigation for IMIGRAN Tablet
|
N/A | |
| Completed |
NCT02183688 -
Acetylsalicylic Acid (ASA) + Paracetamol + Caffeine Combination Compared With ASA + Paracetamol as Well as ASA, Paracetamol, and Caffeine in Headache Patients
|
Phase 3 | |
| Completed |
NCT06061588 -
"Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches"
|
N/A | |
| Completed |
NCT03588364 -
The Role of Osteopathic Manipulation in the the Management of Post-traumatic Migraine
|
N/A | |
| Completed |
NCT04091321 -
Association Between Chronic Headache and Back Pain With Childbirth
|
||
| Completed |
NCT00385008 -
TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine
|
Phase 3 | |
| Active, not recruiting |
NCT05888298 -
Proximal and Distal Approach GON RFT in Migraine
|
N/A | |
| Completed |
NCT03435185 -
Greater Occipital and Supraorbital Nerve Blockade in Migraine Patients
|
N/A | |
| Recruiting |
NCT06459635 -
Migraine Attack Pain Phase Prediction Study
|
||
| Completed |
NCT02565186 -
An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
|
Phase 3 |