Chronic PainNCT03493308
Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain
A study testing Pain neuroscience education and Exercise in people with Chronic Pain, run by Aveiro University at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain neuroscience education and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 sitePortugal
- Study dates
- 12 Apr 2018to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- Have any contra-indication to exercise and have cognitive limitations (evaluated through the Montreal Cognitive Assessment questionnaire).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Pain neuroscience education, Exercise
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience educationOther
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.
ExerciseOther
Exercise will be provided in different formats including general exercise, strengthening, dance.
| Study group | Role | What they receive |
|---|---|---|
| Pain neuroscience and exercise | Experimental | 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. Receives: Other: Pain neuroscience education; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 3 months
Secondary outcomes (24)
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Measured: Baseline
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Measured: 9 weeks
Pain location
Assessed using a body chart where the patients identifies the painful body segments
Measured: 3 months
Pain frequency
Assessed using a closed question on pain frequency for the last week
Measured: Baseline
Pain frequency
Assessed using a closed question on pain frequency for the last week
Measured: 9 weeks
Pain frequency
Assessed using a closed question on pain frequency for the last week
Measured: 3 months
Depression
Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
Measured: Baseline
Depression
Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
Measured: 9 weeks
Depression
Assessed using the Geriatric Depression Scale (range 0-15 and values of 5 or higher are indicative of depression)
Measured: 3 months
Knowledge of pain neuroscience
Assessed using the pain neurophysiology questionnaire
Measured: 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)
Measured: 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)
Measured: 3 months
Pain catastrophizing
assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Measured: Baseline
Pain catastrophizing
assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Measured: 9 weeks
Pain catastrophizing
assessed using the Pain Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Measured: 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)
Measured: Baseline
Fear of movement
Assessed using the TAMPA Scale (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Measured: 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)
Measured: 3 months
Gait velocity
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
Measured: Baseline
Gait velocity
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
Measured: 9 weeks
Gait velocity
Assessed using the gait velocity test - the time, in seconds, that each participant takes to walk 4 meters
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start12 Apr 2018
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
- Investigators
- Anabela Silva, PhD, Principal investigator, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493308
- Sponsor's protocol ID
- 09-CED/2018
- Status last verified
- Sep 2018
- First submitted
- 4 Apr 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education and Exercise in Institutionalized Older Adults With Pain: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03493308
- Acronym / sponsor ID
- 09-CED/2018
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain neuroscience and exercise | Experimental | Other: Pain neuroscience education, Other: ExerciseParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Have any contra-indication to exercise and have cognitive limitations (evaluated through the Montreal Cognitive Assessment questionnaire).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain neuroscience educationPNE 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 | Pain neuroscience and exercise |
| ExerciseExercise will be provided in different formats including general exercise, strengthening, dance. | Other | Pain neuroscience and exercise |
Primary outcome
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)
24 secondary outcomes
Pain location
Time frame: Baseline
Pain location
Time frame: 9 weeks
Pain location
Time frame: 3 months
Pain frequency
Time frame: Baseline
Pain frequency
Time frame: 9 weeks
Pain frequency
Time frame: 3 months
Depression
Time frame: Baseline
Depression
Time frame: 9 weeks
Depression
Time frame: 3 months
Knowledge of pain neuroscience
Time frame: Baseline
Knowledge of pain neuroscience
Time frame: 9 weeks
Knowledge of pain neuroscience
Time frame: 3 months
Pain catastrophizing
Time frame: Baseline
Pain catastrophizing
Time frame: 9 weeks
Pain catastrophizing
Time frame: 3 months
Fear of movement
Time frame: Baseline
Fear of movement
Time frame: 9 weeks
Fear of movement
Time frame: 3 months
Gait velocity
Time frame: Baseline
Gait velocity
Time frame: 9 weeks
Gait velocity
Time frame: 3 months
Postural control
Time frame: Baseline
Postural control
Time frame: 9 weeks
Postural control
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anabela Silva, PhD principal investigator
Aveiro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain neuroscience education and Exercise in people with Chronic Pain, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.