NCT05777343

Brief Summary

This study aims of to investigate whether combining cognitive training to exercise and Pain Neuroscience Education will contribute to reduction of pain and associated symptoms (i.e., catastrophizing, fear of movement, disability) in individuals with low back pain (LBP).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

February 23, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
20 days until next milestone

Study Start

First participant enrolled

April 10, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

February 23, 2023

Last Update Submit

November 8, 2023

Conditions

Chronic Low-back Pain

Keywords

cognitive trainingexercisechronic low back painpain neuroscience education

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale Numeric Pain Rating Scale

    Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".

    baseline

  • Numeric Pain Rating Scale Numeric Pain Rating Scale

    Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".

    post-intervention - 8 weeks

  • Numeric Pain Rating Scale Numeric Pain Rating Scale

    Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".

    3 months follow-up

Secondary Outcomes (26)

  • Cognitive Function

    baseline

  • Cognitive Function

    post-intervention - 8 weeks

  • Cognitive Function

    3 months follow-up.

  • Roland Morris disability questionnaire

    baseline

  • Roland Morris disability questionnaire

    post-intervention - 8 weeks

  • +21 more secondary outcomes

Study Arms (3)

Intervention 1

EXPERIMENTAL

Participants will receive exercise, PNE and online cognitive training sessions.

Other: Experimental

Intervention 2

ACTIVE COMPARATOR

Participants will receive exercise and pain neuroscience education (PNE).

Other: Exercise and PNE

Intervention 3

ACTIVE COMPARATOR

Participants will receive online cognitive training sessions.

Other: Cognitive training

Interventions

ExperimentalOTHER

Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).

Intervention 1
Exercise and PNEOTHER

Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).

Intervention 2
Cognitive trainingOTHER

Online sessions of cognitive training.

Intervention 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have chronic idiopathic LBP
  • report pain intensity of at least 2 out of 10 on the Numeric Pain Rating Scale
  • to 64 years old
  • Be able to read, write and speak Portuguese
  • Asses to personal computer and internet for those receiving cognitive training

You may not qualify if:

  • individuals receiving any chronic treatment for their pain
  • symptoms of peripheral nervous system pathology (e.g., motor weakness and sensory disturbance);
  • a diagnosis of an ongoing neurological disease with peripheral or central nervous system involvement or relevant sequela;
  • having a diagnosis of ongoing psychiatric disease
  • having relevant cognitive impairment as assessed by Montreal Cognitive Assessment (MoCA).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aveiro

Aveiro, Portugal

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

ExerciseCognitive Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Anabela Silva, PhD

    School of Health Sciences, University of Aveiro

    STUDY DIRECTOR

Central Study Contacts

Ellen P. Nery, Ms.

CONTACT

+351234370200ellen.nery@ua.pt

Anabela Silva

CONTACT

+351234370200asilva@ua.pt

Study Design

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

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 21, 2023

Study Start

April 10, 2023

Primary Completion

February 10, 2024

Study Completion

March 1, 2024

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

PT(1)