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Pain Resilience and Holistic Health Care of Migraine

Primary Purpose

Migraine Disorders

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cognitive behavioral therapy
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosed with migraine

Exclusion Criteria:

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

Sites / Locations

  • Changhua Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

CBT group

exercise therapy group

breathe training group

usual care

Arm Description

cognitive behavioral therapy (CBT)+routine medical care

physiotherapy-exercise therapy+routine medical care

using biofeedback devices to train breathing speed+routine medical care

accepting only routine medical care

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

heart rate variability
measured with wearable devices

Full Information

First Posted
February 3, 2021
Last Updated
September 26, 2023
Sponsor
Changhua Christian Hospital
Collaborators
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04743492
Brief Title
Pain Resilience and Holistic Health Care of Migraine
Official Title
How Pain Resilience Determines the Efficacy of Holistic Health Care of Patients With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Changhua Christian Hospital
Collaborators
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT group
Arm Type
Experimental
Arm Description
cognitive behavioral therapy (CBT)+routine medical care
Arm Title
exercise therapy group
Arm Type
Experimental
Arm Description
physiotherapy-exercise therapy+routine medical care
Arm Title
breathe training group
Arm Type
Experimental
Arm Description
using biofeedback devices to train breathing speed+routine medical care
Arm Title
usual care
Arm Type
No Intervention
Arm Description
accepting only routine medical care
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Intervention Description
cognitive behavioral therapy delivered by clinical psychologists in order to help patients gain coping skills.
Primary Outcome Measure Information:
Title
level of disability
Description
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.
Time Frame
8 weeks
Title
severity of pain
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
heart rate variability
Description
measured with wearable devices
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed with migraine Exclusion Criteria: uncontrolled hypertension coronary artery disease arrhythmia secondary headache(except for medication overuse headache)a age under 20
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling-Jun Liu, MSc
Organizational Affiliation
Changhua Christian Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhua Christian Hospital
City
Chang Hua
ZIP/Postal Code
500
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain Resilience and Holistic Health Care of Migraine

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