NCT04528160

Brief Summary

This study aims to investigate the feasibility of using pain neuroscience education for older adults with chronic pain from primary care services. It will have a group of participants receiving pain neuroscience education and exercise and a group receiving usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Apr 2018

Typical duration 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

Study Start

First participant enrolled

April 1, 2018

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

2.5 years

First QC Date

August 24, 2020

Last Update Submit

July 14, 2022

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (7)

  • Inclusion rate

    ratio between the number of participants included in the study and the total number of people contacted

    9 weeks

  • Refusal rate

    ratio between the number of individuals who refused to participate in the study and the number of individuals contacted

    9 weeks

  • Exclusion rate

    ratio between the number of individuals excluded for not meeting the inclusion criteria and the total number of individuals contacted

    9 weeks

  • Dropout rate

    ratio between the number of participants who abandoned the study and the number of participants who completed the initial assessment

    9 weeks

  • Retention rate

    ratio between the number of participants who completed the final assessment and the number of participants who completed the initial assessment

    9 weeks

  • Number of participants reporting adverse events

    Self-report of any adverse event perceived as being related to the intervention

    9 weeks

  • Perception of participants towards the intervention structure and content

    Semi-structured interviews with participants on the structure and content of the intervention

    9 weeks

Secondary Outcomes (26)

  • Pain severity and interference

    Baseline

  • Pain severity and interference

    9 weeks

  • Pain severity and interference

    6 months

  • Pain catastrophizing

    Baseline

  • Pain catastrophizing

    9 weeks

  • +21 more secondary outcomes

Study Arms (2)

Pain neuroscience education and exercise

EXPERIMENTAL

This group will receive an 8-week intervention (1 session per week) of pain neuroscience education and exercise. 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 will include mobility, balance and strength exercises.

Other: Pain neuroscience education and exercise

Usual care

ACTIVE COMPARATOR

This group will receive usual care administered by general practitioners at primary care.

Other: Usual Care

Interventions

Pain neuroscience education and exerciseOTHER

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 will included genera exercise delivered at moderate intensity.

Pain neuroscience education and exercise
Usual CareOTHER

Usual care delivered at primary care for older adults with pain.

Usual care

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be able to read and write and 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.

You may not qualify if:

  • presence of pathology of the nervous or cardiovascular systems, cancer, or having had a surgery in the last 6 months or the presence of a condition for which the practice of therapeutic exercise could be contraindicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health Sciences

Aveiro, 3810-193, Portugal

Location

Related Publications (1)

  • Heleno E, Andias R, Neto M, Silva AG. A Feasibility Study of Pain Neuroscience Education and Exercise for Community-Dwelling Older Adults With Chronic Pain. J Geriatr Phys Ther. 2023 Jan-Mar 01;46(1):26-35. doi: 10.1519/JPT.0000000000000327. Epub 2021 Aug 19.

    PMID: 34417415DERIVED

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 Design

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

Study Record Dates

First Submitted

August 24, 2020

First Posted

August 27, 2020

Study Start

April 1, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

July 18, 2022

Record last verified: 2022-07

Locations

PT(1)