NCT03493308

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

April 12, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

April 4, 2018

Last Update Submit

September 10, 2018

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (24)

  • Pain location

    Baseline

  • Pain location

    9 weeks

  • Pain location

    3 months

  • Pain frequency

    Baseline

  • Pain frequency

    9 weeks

  • +19 more secondary outcomes

Study Arms (1)

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.

Other: Pain neuroscience educationOther: Exercise

Interventions

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.

Pain neuroscience and exercise
ExerciseOTHER

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

Pain neuroscience and exercise

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Have any contra-indication to exercise and have cognitive limitations (evaluated through the Montreal Cognitive Assessment questionnaire).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lar de Fermentelos

Águeda Municipality, Portugal

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anabela Silva, PhD

    Aveiro University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 10, 2018

Study Start

April 12, 2018

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)