Pain Neuroscience Education for Older Adults

Chronic Pain Clinical Trial

Official title:

Pain Neuroscience Education for Older Adults With Pain From Primary Care: a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04528160
• Other study ID #: PNE4OlderAdults
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: July 2022
• Source: Aveiro University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Other:
• 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 included genera exercise delivered at moderate intensity.
• Usual Care
Usual care delivered at primary care for older adults with pain.

Locations

Country	Name	City	State
Portugal	School of Health Sciences	Aveiro

Sponsors (1)

Lead Sponsor	Collaborator
Aveiro University

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inclusion rate	ratio between the number of participants included in the study and the total number of people contacted	9 weeks
Primary	Refusal rate	ratio between the number of individuals who refused to participate in the study and the number of individuals contacted	9 weeks
Primary	Exclusion rate	ratio between the number of individuals excluded for not meeting the inclusion criteria and the total number of individuals contacted	9 weeks
Primary	Dropout rate	ratio between the number of participants who abandoned the study and the number of participants who completed the initial assessment	9 weeks
Primary	Retention rate	ratio between the number of participants who completed the final assessment and the number of participants who completed the initial assessment	9 weeks
Primary	Number of participants reporting adverse events	Self-report of any adverse event perceived as being related to the intervention	9 weeks
Primary	Perception of participants towards the intervention structure and content	Semi-structured interviews with participants on the structure and content of the intervention	9 weeks
Secondary	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)	Baseline
Secondary	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)	9 weeks
Secondary	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)	6 months
Secondary	Pain catastrophizing	Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)	Baseline
Secondary	Pain catastrophizing	Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)	9 weeks
Secondary	Pain catastrophizing	Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)	6 months
Secondary	Depression	Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)	Baseline
Secondary	Depression	Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)	9 weeks
Secondary	Depression	Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)	6 months
Secondary	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)	Baseline
Secondary	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)	6 weeks
Secondary	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)	6 months
Secondary	Knowledge of pain neuroscience	Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)	Baseline
Secondary	Knowledge of pain neuroscience	Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)	9 weeks
Secondary	Knowledge of pain neuroscience	Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)	6 months
Secondary	Gait velocity	Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters	Baseline
Secondary	Gait velocity	Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters	9 weeks
Secondary	Gait velocity	Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters	6 months
Secondary	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.	Baseline
Secondary	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.	9 weeks
Secondary	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.	6 months
Secondary	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)	Baseline
Secondary	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)	9 weeks
Secondary	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)	6 months
Secondary	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)	9 weeks
Secondary	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)	6 months