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Clinical Trials/NCT05777343
NCT05777343
Recruiting
Not Applicable

Pain Neuroscience Education, Exercise, and Cognitive Training in Individuals With Idiopathic Chronic Low Back Pain: a Three-arm Randomized Trial

Aveiro University1 site in 1 country83 target enrollmentApril 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low-back Pain
Sponsor
Aveiro University
Enrollment
83
Locations
1
Primary Endpoint
Numeric Pain Rating Scale Numeric Pain Rating Scale
Status
Recruiting
Last Updated
2 years ago

Overview

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).

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 10, 2023
End Date
March 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aveiro University
Responsible Party
Principal Investigator
Principal Investigator

Ellen Hirose Pereira Nery

Principal Investigator

Aveiro University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Numeric Pain Rating Scale Numeric Pain Rating Scale

Time Frame: 3 months follow-up

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

Secondary Outcomes

  • Central sensitization Inventory(3 months follow-up)
  • Pain Catastrophizing Scale(3 months follow-up.)
  • Two-point discrimination(3 months follow-up)
  • Patient's Global Impression of Change (PGIC)(3 months follow-up.)
  • Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)(3 months follow-up.)
  • Cognitive Function(3 months follow-up.)
  • Roland Morris disability questionnaire(3 months follow-up)
  • Hospital Anxiety and Depression Scale (HADS)(3 months follow-up.)
  • TAMPA Scale of Kinesiophobia(3 months follow-up.)

Study Sites (1)

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