Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain

September 10, 2018 updated by: Anabela G Silva, Aveiro University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Águeda, Portugal
        • Lar de Fermentelos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline
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)
9 weeks
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)
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain location
Time Frame: Baseline
Assessed using a body chart where the patients identifies the painful body segments
Baseline
Pain location
Time Frame: 9 weeks
Assessed using a body chart where the patients identifies the painful body segments
9 weeks
Pain location
Time Frame: 3 months
Assessed using a body chart where the patients identifies the painful body segments
3 months
Pain frequency
Time Frame: Baseline
Assessed using a closed question on pain frequency for the last week
Baseline
Pain frequency
Time Frame: 9 weeks
Assessed using a closed question on pain frequency for the last week
9 weeks
Pain frequency
Time Frame: 3 months
Assessed using a closed question on pain frequency for the last week
3 months
Depression
Time Frame: Baseline
Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
Baseline
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 weeks
Depression
Time Frame: 3 months
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
Time Frame: Baseline
Assessed using the pain neurophysiology questionnaire
Baseline
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)
9 weeks
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)
3 months
Pain catastrophizing
Time Frame: Baseline
assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Baseline
Pain catastrophizing
Time Frame: 9 weeks
assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
9 weeks
Pain catastrophizing
Time Frame: 3 months
assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
3 months
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)
Baseline
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)
9 weeks
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)
3 months
Gait velocity
Time Frame: Baseline
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
Baseline
Gait velocity
Time Frame: 9 weeks
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
9 weeks
Gait velocity
Time Frame: 3 months
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
3 months
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.
Baseline
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.
9 weeks
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aveiro University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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