Pain Neuroscience Education for Older Adults

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Pain neuroscience education and exercise; Other: Usual Care

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Aveiro, Portugal, 3810-193
    • School of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain neuroscience education and exercise; 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.	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.
Active Comparator: Usual care; This group will receive usual care administered by general practitioners at primary care.	Other: Usual Care; Usual care delivered at primary care for older adults with pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inclusion rate	ratio between the number of participants included in the study and the total number of people contacted	9 weeks
Refusal rate	ratio between the number of individuals who refused to participate in the study and the number of individuals contacted	9 weeks
Exclusion rate	ratio between the number of individuals excluded for not meeting the inclusion criteria and the total number of individuals contacted	9 weeks
Dropout rate	ratio between the number of participants who abandoned the study and the number of participants who completed the initial assessment	9 weeks
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
Number of participants reporting adverse events	Self-report of any adverse event perceived as being related to the intervention	9 weeks
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)	Baseline
Depression	Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)	9 weeks
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
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
Gait velocity	Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters	Baseline
Gait velocity	Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters	9 weeks
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
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
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
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
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
Pain catastrophizing	Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)	Baseline
Pain catastrophizing	Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)	9 weeks
Pain catastrophizing	Assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)	6 months
Depression	Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)	6 months
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
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
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
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
Gait velocity	Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters	6 months
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Aveiro University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: PNE4OlderAdults

Drug and device information, study documents

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