Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Pain neuroscience education; Other: Exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Águeda, Portugal
    • Lar de Fermentelos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)	Baseline
Pain intensity	Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)	9 weeks
Pain intensity	Assessed using the vertical numeric rating scale that assesses pain intensity (range 0-10 and higher values are indicative of higher pain intensity)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain location	Assessed using a body chart where the patients identifies the painful body segments	Baseline
Pain location	Assessed using a body chart where the patients identifies the painful body segments	9 weeks
Pain location	Assessed using a body chart where the patients identifies the painful body segments	3 months
Pain frequency	Assessed using a closed question on pain frequency for the last week	Baseline
Pain frequency	Assessed using a closed question on pain frequency for the last week	9 weeks
Pain frequency	Assessed using a closed question on pain frequency for the last week	3 months
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
Depression	Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)	3 months
Knowledge of pain neuroscience	Assessed using the pain neurophysiology questionnaire	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)	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)	3 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)	3 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)	Baseline
Fear of movement	Assessed using the TAMPA Scale (range: 13-52 and higher values are indicative of higher levels of fear of movement)	9 weeks
Fear of movement	Assessed using the TAMPA Scale (range: 13-52 and higher values are indicative of higher levels of fear of movement)	3 months
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
Gait velocity	Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters	3 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.	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
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.	3 months

Collaborators and Investigators

• Sponsor: Aveiro University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 09-CED/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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