Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03493308
• Other study ID #: 09-CED/2018
• Status: Completed
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: September 2018
• Source: Aveiro University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
Portugal	Lar de Fermentelos	Águeda

Sponsors (1)

Lead Sponsor	Collaborator
Aveiro University

Country where clinical trial is conducted

Portugal, 

Outcome

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