Skip to content

Pain Resilience and Holistic Health Care of Migraine

How Pain Resilience Determines the Efficacy of Holistic Health Care of Patients With Migraine

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04743492
Enrollment
50
Registered
2021-02-08
Start date
2021-04-16
Completion date
2024-05-31
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALcognitive behavioral therapy

cognitive behavioral therapy delivered by clinical psychologists in order to help patients gain coping skills.

Sponsors

Chung Shan Medical University
CollaboratorOTHER
Changhua Christian Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* diagnosed with migraine

Exclusion criteria

* uncontrolled hypertension * coronary artery disease * arrhythmia * secondary headache(except for medication overuse headache)a * age under 20

Design outcomes

Primary

MeasureTime frameDescription
level of disability8 weeksMeasured with the Migraine Disability Assessment Test (MIDAS). The total score ranges from 0 to 21 or more. Higher score indicates more disabilities related to migraine. Score over 21 indicates severe disability.
severity of pain8 weeksSelf-reported pain scores range from 0 to 10, with 0 meaning no pain at all, and 10 meaning extreme pain. Scoring over 7 indicates severe pain.

Secondary

MeasureTime frameDescription
heart rate variability8 weeksmeasured with wearable devices

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026