Exercise, PNE and Cognitive Training in Individuals With Chronic Low Back Pain

NCT ID: NCT05777343

Last Updated: 2023-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-10

Study Completion Date

2024-03-01

Brief Summary

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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).

Detailed Description

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

It will have three arms of which will receive exercise, PNE and/or cognitive training for 8 weeks (Group I - exercise and PNE; Group II - exercise, PNE and cognitive training; Group III - cognitive training).

Participants will be assessed for pain characteristics, psychological, and cognitive aspects at baseline, post-intervention and at 3 months follow-up.

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention 1

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

Group Type EXPERIMENTAL

Experimental

Intervention Type OTHER

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

Intervention 2

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

Group Type ACTIVE_COMPARATOR

Exercise and PNE

Intervention Type OTHER

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

Intervention 3

Participants will receive online cognitive training sessions.

Group Type ACTIVE_COMPARATOR

Cognitive training

Intervention Type OTHER

Online sessions of cognitive training.

Interventions

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Experimental

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

Intervention Type OTHER

Exercise and PNE

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

Intervention Type OTHER

Cognitive training

Online sessions of cognitive training.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role collaborator

RISE Study Group

NETWORK

Sponsor Role collaborator

Aveiro University

OTHER

Sponsor Role lead

Responsible Party

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Ellen Hirose Pereira Nery

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anabela Silva, PhD

Role: STUDY_DIRECTOR

School of Health Sciences, University of Aveiro

Locations

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University of Aveiro

Aveiro, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Ellen P. Nery, Ms.

Role: CONTACT

+351234370200

Anabela Silva

Role: CONTACT

+351234370200

Facility Contacts

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Ellen Nery

Role: primary

Other Identifiers

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RCTCognitiveTraining

Identifier Type: -

Identifier Source: org_study_id

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