Pain Resilience and Holistic Health Care of Migraine

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine Disorders
• Intervention / Treatment: Behavioral: cognitive behavioral therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Chang Hua, Taiwan, 500
    • Changhua Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• diagnosed with migraine

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT group; cognitive behavioral therapy (CBT)+routine medical care	Behavioral: cognitive behavioral therapy; cognitive behavioral therapy delivered by clinical psychologists in order to help patients gain coping skills.
Experimental: exercise therapy group; physiotherapy-exercise therapy+routine medical care	Behavioral: cognitive behavioral therapy; cognitive behavioral therapy delivered by clinical psychologists in order to help patients gain coping skills.
Experimental: breathe training group; using biofeedback devices to train breathing speed+routine medical care	Behavioral: cognitive behavioral therapy; cognitive behavioral therapy delivered by clinical psychologists in order to help patients gain coping skills.
No Intervention: usual care; accepting only routine medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of disability	Measured 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.	8 weeks
severity of pain	Self-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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate variability	measured with wearable devices	8 weeks

Collaborators and Investigators

• Sponsor: Changhua Christian Hospital
• Collaborators: Chung Shan Medical University
• Investigators: Principal Investigator: Ling-Jun Liu, MSc, Changhua Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Actual): February 28, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: Y_109_0314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No