Clinical trial NCT05777343: Exercise, PNE and Cognitive Training in Individuals With Chronic Low Back Pain
Official title: Pain Neuroscience Education, Exercise, and Cognitive Training in Individuals With Idiopathic Chronic Low Back Pain: a Three-arm Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: cognitive training
exercise
chronic low back pain
pain neuroscience education
Lead sponsor: Aveiro University
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: RISE Study Group
First posted: 2023-03-21
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Numeric Pain Rating Scale Numeric Pain Rating Scale
timeFrame: baseline
measure: Numeric Pain Rating Scale Numeric Pain Rating Scale
timeFrame: post-intervention - 8 weeks
measure: Numeric Pain Rating Scale Numeric Pain Rating Scale
timeFrame: 3 months follow-up
Secondary outcomes:
measure: Cognitive Function
timeFrame: baseline
measure: Cognitive Function
timeFrame: post-intervention - 8 weeks
measure: Cognitive Function
timeFrame: 3 months follow-up.
measure: Roland Morris disability questionnaire
timeFrame: baseline
measure: Roland Morris disability questionnaire
timeFrame: post-intervention - 8 weeks
measure: Roland Morris disability questionnaire
timeFrame: 3 months follow-up
measure: Central sensitization Inventory
timeFrame: baseline
measure: Central sensitization Inventory
timeFrame: post-intervention - 8 weeks
measure: Central sensitization Inventory
timeFrame: 3 months follow-up
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: post-intervention - 8 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months follow-up.
measure: TAMPA Scale of Kinesiophobia
timeFrame: baseline
measure: TAMPA Scale of Kinesiophobia
timeFrame: post-intervention - 8 weeks
measure: TAMPA Scale of Kinesiophobia
timeFrame: 3 months follow-up.
measure: Pain Catastrophizing Scale
timeFrame: Baseline
measure: Pain Catastrophizing Scale
timeFrame: post-intervention - 8 weeks
measure: Pain Catastrophizing Scale
timeFrame: 3 months follow-up.
measure: Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
timeFrame: baseline
measure: Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
timeFrame: post-intervention - 8 weeks
measure: Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
timeFrame: 3 months follow-up.
measure: Two-point discrimination
timeFrame: baseline
measure: Two-point discrimination
timeFrame: post-intervention - 8 weeks
measure: Two-point discrimination
timeFrame: 3 months follow-up
measure: Patient's Global Impression of Change (PGIC)
timeFrame: post-intervention - 8 weeks
measure: Patient's Global Impression of Change (PGIC)
timeFrame: 3 months follow-up.
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: University of Aveiro
Study officials:
affiliation: School of Health Sciences, University of Aveiro
name: Anabela Silva, PhD
role: STUDY_DIRECTOR
References: