Skip to main content
OpenTrials
Completed

NCT Number: NCT03493308

Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lar de Fermentelos

Águeda Municipality, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Pain neuroscience education

Other

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

Other

Exercise will be provided in different formats including general exercise, strengthening, dance.

Primary outcomes

  1. Pain intensity

    Time frame: Baseline

    Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)

  2. Pain intensity

    Time frame: 9 weeks

    Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)

  3. Pain intensity

    Time frame: 3 months

    Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)

Secondary outcomes

  1. Pain location

    Time frame: Baseline

    Assessed using a body chart where the patients identifies the painful body segments

  2. Pain location

    Time frame: 9 weeks

    Assessed using a body chart where the patients identifies the painful body segments

  3. Pain location

    Time frame: 3 months

    Assessed using a body chart where the patients identifies the painful body segments

  4. Pain frequency

    Time frame: Baseline

    Assessed using a closed question on pain frequency for the last week

  5. Pain frequency

    Time frame: 9 weeks

    Assessed using a closed question on pain frequency for the last week

  6. Pain frequency

    Time frame: 3 months

    Assessed using a closed question on pain frequency for the last week

  7. Depression

    Time frame: Baseline

    Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)

  8. Depression

    Time frame: 9 weeks

    Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)

  9. Depression

    Time frame: 3 months

    Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)

  10. Knowledge of pain neuroscience

    Time frame: Baseline

    Assessed using the pain neurophysiology questionnaire

  11. Knowledge of pain neuroscience

    Time frame: 9 weeks

    Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)

  12. Knowledge of pain neuroscience

    Time frame: 3 months

    Assessed using the pain neurophysiology questionnaire (range 0-19 and higher values are indicative of more knowledge on pain neurophysiology)

  13. Pain catastrophizing

    Time frame: Baseline

    assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)

  14. Pain catastrophizing

    Time frame: 9 weeks

    assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)

  15. Pain catastrophizing

    Time frame: 3 months

    assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)

  16. Fear of movement

    Time frame: Baseline

    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)

  17. Fear of movement

    Time frame: 9 weeks

    Assessed using the TAMPA Scale (range: 13-52 and higher values are indicative of higher levels of fear of movement)

  18. Fear of movement

    Time frame: 3 months

    Assessed using the TAMPA Scale (range: 13-52 and higher values are indicative of higher levels of fear of movement)

  19. Gait velocity

    Time frame: Baseline

    Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters

  20. Gait velocity

    Time frame: 9 weeks

    Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters

  21. Gait velocity

    Time frame: 3 months

    Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters

  22. Postural control

    Time frame: Baseline

    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.

  23. Postural control

    Time frame: 9 weeks

    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.

  24. Postural control

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Registry information

Official study title

Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain: A Feasibility Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 10, 2018
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.