Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain

Overview

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.

Full Title of Study: “Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain: A Feasibility Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2018

Detailed Description

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.

Interventions

  • Other: Pain neuroscience education
    • 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.
  • Other: Exercise
    • Exercise will be provided in different formats including general exercise, strengthening, dance.

Arms, Groups and Cohorts

  • Experimental: Pain neuroscience and exercise
    • Participants will received an 8 week intervention consisting of pain neuroscience education and exercise. Pain neuroscience education will be conducted in line with international guidelines, covering the neurophysiology of pain, transition from from acute to chronic pain and the nervous system ability to modulate the pain experience. exercise will include general exercise and dance.

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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)
  • 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 Measures

  • Pain location
    • Time Frame: Baseline
    • Assessed using a body chart where the patients identifies the painful body segments
  • Pain location
    • Time Frame: 9 weeks
    • Assessed using a body chart where the patients identifies the painful body segments
  • Pain location
    • Time Frame: 3 months
    • Assessed using a body chart where the patients identifies the painful body segments
  • Pain frequency
    • Time Frame: Baseline
    • Assessed using a closed question on pain frequency for the last week
  • Pain frequency
    • Time Frame: 9 weeks
    • Assessed using a closed question on pain frequency for the last week
  • Pain frequency
    • Time Frame: 3 months
    • Assessed using a closed question on pain frequency for the last week
  • Depression
    • Time Frame: Baseline
    • Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
  • Depression
    • Time Frame: 9 weeks
    • Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
  • Depression
    • Time Frame: 3 months
    • Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
  • Knowledge of pain neuroscience
    • Time Frame: Baseline
    • Assessed using the pain neurophysiology questionnaire
  • 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)
  • 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)
  • Pain catastrophizing
    • Time Frame: Baseline
    • assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
  • Pain catastrophizing
    • Time Frame: 9 weeks
    • assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
  • Pain catastrophizing
    • Time Frame: 3 months
    • assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
  • 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)
  • 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)
  • 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)
  • Gait velocity
    • Time Frame: Baseline
    • Assessed using the gait velocity test – the time, in seconds, that each participant takes to walk 4 meters
  • Gait velocity
    • Time Frame: 9 weeks
    • Assessed using the gait velocity test – the time, in seconds, that each participant takes to walk 4 meters
  • Gait velocity
    • Time Frame: 3 months
    • Assessed using the gait velocity test – the time, in seconds, that each participant takes to walk 4 meters
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aveiro University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anabela G Silva, Assistant Professor – Aveiro University
  • Overall Official(s)
    • Anabela Silva, PhD, Principal Investigator, Aveiro University

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