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CompletedNCT04528160Updated Jul 18, 2022

Pain Neuroscience Education for Older Adults

An interventional study of Pain neuroscience education and exercise and Usual Care in Chronic Pain, sponsored by Aveiro University. Completed at 1 site in Portugal. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2022-07-18.

Sponsored by Aveiro University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 4 months after the study started (first participant enrolled Apr 2018, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Aveiro University is the lead sponsor of 57 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • Active comparator
    Usual care

    This group will receive usual care administered by general practitioners at primary care.

    Other: Usual Care

Interventions

  • OtherPain 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.

  • OtherUsual Care

    Usual care delivered at primary care for older adults with pain.

06

What researchers measure

Primary outcomes

  1. Inclusion rate

    ratio between the number of participants included in the study and the total number of people contacted

    Time frame: 9 weeks

  2. Refusal rate

    ratio between the number of individuals who refused to participate in the study and the number of individuals contacted

    Time frame: 9 weeks

  3. Exclusion rate

    ratio between the number of individuals excluded for not meeting the inclusion criteria and the total number of individuals contacted

    Time frame: 9 weeks

  4. Dropout rate

    ratio between the number of participants who abandoned the study and the number of participants who completed the initial assessment

    Time frame: 9 weeks

  5. Retention rate

    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

  6. Number of participants reporting adverse events

    Self-report of any adverse event perceived as being related to the intervention

    Time frame: 9 weeks

  7. Perception of participants towards the intervention structure and content

    Semi-structured interviews with participants on the structure and content of the intervention

    Time frame: 9 weeks

Secondary outcomes

  1. 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)

    Time frame: Baseline

  2. 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)

    Time frame: 9 weeks

  3. 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)

    Time frame: 6 months

  4. Pain catastrophizing

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

    Time frame: Baseline

  5. Pain catastrophizing

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

    Time frame: 9 weeks

  6. Pain catastrophizing

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

    Time frame: 6 months

  7. Depression

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

    Time frame: Baseline

  8. Depression

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

    Time frame: 9 weeks

  9. Depression

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

    Time frame: 6 months

  10. 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)

    Time frame: Baseline

  11. 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)

    Time frame: 6 weeks

  12. 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)

    Time frame: 6 months

  13. Knowledge of pain neuroscience

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

    Time frame: Baseline

  14. Knowledge of pain neuroscience

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

    Time frame: 9 weeks

  15. Knowledge of pain neuroscience

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

    Time frame: 6 months

  16. Gait velocity

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

    Time frame: Baseline

  17. Gait velocity

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

    Time frame: 9 weeks

  18. Gait velocity

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

    Time frame: 6 months

  19. 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.

    Time frame: Baseline

  20. 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.

    Time frame: 9 weeks

  21. 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.

    Time frame: 6 months

  22. 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)

    Time frame: Baseline

  23. 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)

    Time frame: 9 weeks

  24. 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)

    Time frame: 6 months

  25. 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)

    Time frame: 9 weeks

  26. 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)

    Time frame: 6 months

07

Study locations

1 site
  • School of Health Sciences
    Aveiro, 3810-193, Portugal
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04528160
Lead sponsor
Aveiro University
Responsible party
Anabela G Silva (Assistant Professor, Aveiro University) — Principal investigator
First posted
Aug 27, 2020
Start date
Apr 1, 2018
Primary completion
Oct 1, 2020
Completion
Oct 1, 2020
Last update
Jul 18, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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