Back to resultsPain Neuroscience Education for Older Adults
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Pain neuroscience education and exercise
Usual Care
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- be able to read and write and have chronic pain (defined as pain lasting 3 months or more and felt at least once a week during these 3 months ) anywhere in the body.
Exclusion Criteria:
- presence of pathology of the nervous or cardiovascular systems, cancer, or having had a surgery in the last 6 months or the presence of a condition for which the practice of therapeutic exercise could be contraindicated.
Sites / Locations
- School of Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pain neuroscience education and exercise
Usual care
Arm Description
This group will receive an 8-week intervention (1 session per week) of pain neuroscience education and exercise. PNE will be conducted in line with international guidelines and will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise will include mobility, balance and strength exercises.
This group will receive usual care administered by general practitioners at primary care.
Outcomes
Primary Outcome Measures
Inclusion rate
ratio between the number of participants included in the study and the total number of people contacted
Refusal rate
ratio between the number of individuals who refused to participate in the study and the number of individuals contacted
Exclusion rate
ratio between the number of individuals excluded for not meeting the inclusion criteria and the total number of individuals contacted
Dropout rate
ratio between the number of participants who abandoned the study and the number of participants who completed the initial assessment
Retention rate
ratio between the number of participants who completed the final assessment and the number of participants who completed the initial assessment
Number of participants reporting adverse events
Self-report of any adverse event perceived as being related to the intervention
Perception of participants towards the intervention structure and content
Semi-structured interviews with participants on the structure and content of the intervention
Secondary Outcome Measures
Pain severity and interference
Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)
Pain severity and interference
Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)
Pain severity and interference
Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)
Pain catastrophizing
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Pain catastrophizing
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Pain catastrophizing
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Depression
Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
Depression
Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
Depression
Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
Fear of movement
Assessed using the TAMPA Scale, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Fear of movement
Assessed using the TAMPA Scale, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Fear of movement
Assessed using the TAMPA Scale, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Knowledge of pain neuroscience
Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Knowledge of pain neuroscience
Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Knowledge of pain neuroscience
Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Gait velocity
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
Gait velocity
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
Gait velocity
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
Postural control
Assessed using the Timed up and go test - the time, in seconds, that it takes to stand from a chair, walk 3 meters, turn, walk another 3 meters to sit in the chair.
Postural control
Assessed using the Timed up and go test - the time, in seconds, that it takes to stand from a chair, walk 3 meters, turn, walk another 3 meters to sit in the chair.
Postural control
Assessed using the Timed up and go test - the time, in seconds, that it takes to stand from a chair, walk 3 meters, turn, walk another 3 meters to sit in the chair.
Self-perceived disability
assessed using the World Health Organization Disability Assessment Schedule 2.0 - 12-item version of WHODAS 2.0) questionnaire (range: 12-60 and higher values are indicative of higher levels of disability)
Self-perceived disability
assessed using the World Health Organization Disability Assessment Schedule 2.0 - 12-item version of WHODAS 2.0) questionnaire (range: 12-60 and higher values are indicative of higher levels of disability)
Self-perceived disability
assessed using the World Health Organization Disability Assessment Schedule 2.0 - 12-item version of WHODAS 2.0) questionnaire (range: 12-60 and higher values are indicative of higher levels of disability)
Perception of change
Assessed using the Global Perception of Change scale (answer is given using a 7-point likert scale from 1- no change to 7 - a great deal better and a considerable improvement that has made all the difference)
Perception of change
Assessed using the Global Perception of Change scale (answer is given using a 7-point likert scale from 1- no change to 7 - a great deal better and a considerable improvement that has made all the difference)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04528160
Brief Title
Pain Neuroscience Education for Older Adults
Official Title
Pain Neuroscience Education for Older Adults With Pain From Primary Care: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to investigate the feasibility of using pain neuroscience education for older adults with chronic pain from primary care services. It will have a group of participants receiving pain neuroscience education and exercise and a group receiving usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain neuroscience education and exercise
Arm Type
Experimental
Arm Description
This group will receive an 8-week intervention (1 session per week) of pain neuroscience education and exercise.
PNE will be conducted in line with international guidelines and will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise will include mobility, balance and strength exercises.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
This group will receive usual care administered by general practitioners at primary care.
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education and exercise
Intervention Description
PNE will be conducted in line with international guidelines and will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise will included genera exercise delivered at moderate intensity.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual care delivered at primary care for older adults with pain.
Primary Outcome Measure Information:
Title
Inclusion rate
Description
ratio between the number of participants included in the study and the total number of people contacted
Time Frame
9 weeks
Title
Refusal rate
Description
ratio between the number of individuals who refused to participate in the study and the number of individuals contacted
Time Frame
9 weeks
Title
Exclusion rate
Description
ratio between the number of individuals excluded for not meeting the inclusion criteria and the total number of individuals contacted
Time Frame
9 weeks
Title
Dropout rate
Description
ratio between the number of participants who abandoned the study and the number of participants who completed the initial assessment
Time Frame
9 weeks
Title
Retention rate
Description
ratio between the number of participants who completed the final assessment and the number of participants who completed the initial assessment
Time Frame
9 weeks
Title
Number of participants reporting adverse events
Description
Self-report of any adverse event perceived as being related to the intervention
Time Frame
9 weeks
Title
Perception of participants towards the intervention structure and content
Description
Semi-structured interviews with participants on the structure and content of the intervention
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Pain severity and interference
Description
Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)
Time Frame
Baseline
Title
Pain severity and interference
Description
Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)
Time Frame
9 weeks
Title
Pain severity and interference
Description
Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)
Time Frame
6 months
Title
Pain catastrophizing
Description
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Time Frame
Baseline
Title
Pain catastrophizing
Description
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Time Frame
9 weeks
Title
Pain catastrophizing
Description
Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Time Frame
6 months
Title
Depression
Description
Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
Time Frame
Baseline
Title
Depression
Description
Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
Time Frame
9 weeks
Title
Depression
Description
Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
Time Frame
6 months
Title
Fear of movement
Description
Assessed using the TAMPA Scale, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Time Frame
Baseline
Title
Fear of movement
Description
Assessed using the TAMPA Scale, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Time Frame
6 weeks
Title
Fear of movement
Description
Assessed using the TAMPA Scale, which assesses fear of movement (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Time Frame
6 months
Title
Knowledge of pain neuroscience
Description
Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Time Frame
Baseline
Title
Knowledge of pain neuroscience
Description
Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Time Frame
9 weeks
Title
Knowledge of pain neuroscience
Description
Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)
Time Frame
6 months
Title
Gait velocity
Description
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
Time Frame
Baseline
Title
Gait velocity
Description
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
Time Frame
9 weeks
Title
Gait velocity
Description
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
Time Frame
6 months
Title
Postural control
Description
Assessed using the Timed up and go test - the time, in seconds, that it takes to stand from a chair, walk 3 meters, turn, walk another 3 meters to sit in the chair.
Time Frame
Baseline
Title
Postural control
Description
Assessed using the Timed up and go test - the time, in seconds, that it takes to stand from a chair, walk 3 meters, turn, walk another 3 meters to sit in the chair.
Time Frame
9 weeks
Title
Postural control
Description
Assessed using the Timed up and go test - the time, in seconds, that it takes to stand from a chair, walk 3 meters, turn, walk another 3 meters to sit in the chair.
Time Frame
6 months
Title
Self-perceived disability
Description
assessed using the World Health Organization Disability Assessment Schedule 2.0 - 12-item version of WHODAS 2.0) questionnaire (range: 12-60 and higher values are indicative of higher levels of disability)
Time Frame
Baseline
Title
Self-perceived disability
Description
assessed using the World Health Organization Disability Assessment Schedule 2.0 - 12-item version of WHODAS 2.0) questionnaire (range: 12-60 and higher values are indicative of higher levels of disability)
Time Frame
9 weeks
Title
Self-perceived disability
Description
assessed using the World Health Organization Disability Assessment Schedule 2.0 - 12-item version of WHODAS 2.0) questionnaire (range: 12-60 and higher values are indicative of higher levels of disability)
Time Frame
6 months
Title
Perception of change
Description
Assessed using the Global Perception of Change scale (answer is given using a 7-point likert scale from 1- no change to 7 - a great deal better and a considerable improvement that has made all the difference)
Time Frame
9 weeks
Title
Perception of change
Description
Assessed using the Global Perception of Change scale (answer is given using a 7-point likert scale from 1- no change to 7 - a great deal better and a considerable improvement that has made all the difference)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
be able to read and write and have chronic pain (defined as pain lasting 3 months or more and felt at least once a week during these 3 months ) anywhere in the body.
Exclusion Criteria:
presence of pathology of the nervous or cardiovascular systems, cancer, or having had a surgery in the last 6 months or the presence of a condition for which the practice of therapeutic exercise could be contraindicated.
Facility Information:
Facility Name
School of Health Sciences
City
Aveiro
ZIP/Postal Code
3810-193
Country
Portugal
12. IPD Sharing Statement
Learn more about this trial
Pain Neuroscience Education for Older Adults
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