Back to resultsPain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Pain neuroscience education
Exercise
Sponsored by
About this trial
This is an interventional other trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- Be institutionalized in any type of response (nursing home, day care, ...), be able to read and write, 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, and have a statement from the institution's physician authorizing participation in the exercise sessions.
Exclusion Criteria:
- Have any contra-indication to exercise and have cognitive limitations (evaluated through the Montreal Cognitive Assessment questionnaire).
Sites / Locations
- Lar de Fermentelos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pain neuroscience and exercise
Arm Description
Participants will received an 8 week intervention consisting of pain neuroscience education and exercise. Pain neuroscience education will be conducted in line with international guidelines, covering the neurophysiology of pain, transition from from acute to chronic pain and the nervous system ability to modulate the pain experience. exercise will include general exercise and dance.
Outcomes
Primary Outcome Measures
Pain intensity
Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Pain intensity
Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Pain intensity
Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Secondary Outcome Measures
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Pain frequency
Assessed using a closed question on pain frequency for the last week
Pain frequency
Assessed using a closed question on pain frequency for the last week
Pain frequency
Assessed using a closed question on pain frequency for the last week
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)
Knowledge of pain neuroscience
Assessed using the pain neurophysiology questionnaire
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)
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)
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 (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Fear of movement
Assessed using the TAMPA Scale (range: 13-52 and higher values are indicative of higher levels of fear of movement)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03493308
Brief Title
Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain
Official Title
Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 12, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (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
The primary objectives of this study are to:
Evaluate recruitment procedures and adherence rates;
Evaluate the ability to understand the concepts of pain neurophysiology;
Evaluate the acceptability of an intervention program based on pain neuroscience education and exercise by institutionalized older adults and the institutions where they are.
Detailed Description
Participants will be older adults with pain that are institutionalized and assess the feasibility of implementing an intervention consisting of pain neuroscience education in addition to exercise. It is antecipated that the intervention will consist of 1 to 2 sessions per week during 8 weeks and will be delivered in small groups. Participants will be assessed for pain intensity, duration, catastrophizing, fear of movement, knowledge of pain neuroscience, depression and performance.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain neuroscience and exercise
Arm Type
Experimental
Arm Description
Participants will received an 8 week intervention consisting of pain neuroscience education and exercise. Pain neuroscience education will be conducted in line with international guidelines, covering the neurophysiology of pain, transition from from acute to chronic pain and the nervous system ability to modulate the pain experience. exercise will include general exercise and dance.
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Exercise will be provided in different formats including general exercise, strengthening, dance.
Primary Outcome Measure Information:
Title
Pain intensity
Description
Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Time Frame
Baseline
Title
Pain intensity
Description
Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Time Frame
9 weeks
Title
Pain intensity
Description
Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain location
Description
Assessed using a body chart where the patients identifies the painful body segments
Time Frame
Baseline
Title
Pain location
Description
Assessed using a body chart where the patients identifies the painful body segments
Time Frame
9 weeks
Title
Pain location
Description
Assessed using a body chart where the patients identifies the painful body segments
Time Frame
3 months
Title
Pain frequency
Description
Assessed using a closed question on pain frequency for the last week
Time Frame
Baseline
Title
Pain frequency
Description
Assessed using a closed question on pain frequency for the last week
Time Frame
9 weeks
Title
Pain frequency
Description
Assessed using a closed question on pain frequency for the last week
Time Frame
3 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
3 months
Title
Knowledge of pain neuroscience
Description
Assessed using the pain neurophysiology questionnaire
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
3 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
3 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 (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Time Frame
9 weeks
Title
Fear of movement
Description
Assessed using the TAMPA Scale (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Time Frame
3 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
3 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
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be institutionalized in any type of response (nursing home, day care, ...), be able to read and write, 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, and have a statement from the institution's physician authorizing participation in the exercise sessions.
Exclusion Criteria:
Have any contra-indication to exercise and have cognitive limitations (evaluated through the Montreal Cognitive Assessment questionnaire).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anabela Silva, PhD
Organizational Affiliation
Aveiro University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lar de Fermentelos
City
Águeda
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain
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