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Completed

NCT Number: NCT04528160

Pain Neuroscience Education for Older Adults

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.

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Key information

Conditions

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

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Health Sciences

Aveiro, 3810-193, Portugal

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Pain Neuroscience Education and Exercise

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 will included genera exercise delivered at moderate intensity.

Usual Care

Other

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

Primary outcomes

  1. Inclusion rate

    Time frame: 9 weeks

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

  2. Refusal rate

    Time frame: 9 weeks

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

  3. Exclusion rate

    Time frame: 9 weeks

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

  4. Dropout rate

    Time frame: 9 weeks

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

  5. Retention rate

    Time frame: 9 weeks

    ratio between the number of participants who completed the final assessment and the number of participants who completed the initial assessment

  6. Number of participants reporting adverse events

    Time frame: 9 weeks

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

  7. Perception of participants towards the intervention structure and content

    Time frame: 9 weeks

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

Secondary outcomes

  1. Pain severity and interference

    Time frame: Baseline

    Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)

  2. Pain severity and interference

    Time frame: 9 weeks

    Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)

  3. Pain severity and interference

    Time frame: 6 months

    Assessed using the Brief Pain Inventory questionnaire (range 0-110 and higher values are indicative of higher pain severity and interference)

  4. Pain catastrophizing

    Time frame: Baseline

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

  5. Pain catastrophizing

    Time frame: 9 weeks

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

  6. Pain catastrophizing

    Time frame: 6 months

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

  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: 6 months

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

  10. 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)

  11. Fear of movement

    Time frame: 6 weeks

    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)

  12. Fear of movement

    Time frame: 6 months

    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)

  13. Knowledge of pain neuroscience

    Time frame: Baseline

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

  14. 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)

  15. Knowledge of pain neuroscience

    Time frame: 6 months

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

  16. Gait velocity

    Time frame: Baseline

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

  17. Gait velocity

    Time frame: 9 weeks

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

  18. Gait velocity

    Time frame: 6 months

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

  19. 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.

  20. 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.

  21. Postural control

    Time frame: 6 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.

  22. Self-perceived disability

    Time frame: Baseline

    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)

  23. Self-perceived disability

    Time frame: 9 weeks

    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)

  24. Self-perceived disability

    Time frame: 6 months

    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)

  25. Perception of change

    Time frame: 9 weeks

    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)

  26. Perception of change

    Time frame: 6 months

    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)

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2020
Registry last updated
Jul 18, 2022

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.

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