Pain Neuroscience Education, Exercise, and Cognitive Training in Individuals With Idiopathic Chronic Low Back Pain: a Three-arm Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 99
- Locations
- 1
- Primary Endpoint
- Numeric Pain Rating Scale Numeric Pain Rating Scale
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Outcome assessors were masked to group allocation throughout the study. The allocation sequence was kept by a second researcher and the sealed opaque envelope was delivered only after the baseline assessment of each participant had been completed. All baseline assessments were therefore performed before allocation was known. After allocation, participants and the physiotherapist delivering the interventions could not be masked, because the interventions differ in content, setting and mode of delivery.
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Intervention 1
Participants will receive exercise, PNE and online cognitive training sessions.
Intervention: Experimental (Other)
Intervention 2
Participants will receive exercise and pain neuroscience education (PNE).
Intervention: Exercise and PNE (Other)
Intervention 3
Participants will receive online cognitive training sessions.
Intervention: Cognitive training (Other)
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".
Numeric Pain Rating Scale Numeric Pain Rating Scale
Time Frame: baseline
Measured with a 11-point scale ranging from 0 meaning "no pain" to 10 meaning "the worst pain imaginable".
Numeric Pain Rating Scale Numeric Pain Rating Scale
Time Frame: post-intervention - 8 weeks
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.)
- Cognitive Function(baseline)
- Cognitive Function(post-intervention - 8 weeks)
- Roland Morris disability questionnaire(baseline)
- Roland Morris disability questionnaire(post-intervention - 8 weeks)
- Central sensitization Inventory(baseline)
- Central sensitization Inventory(post-intervention - 8 weeks)
- Hospital Anxiety and Depression Scale (HADS)(baseline)
- Hospital Anxiety and Depression Scale (HADS)(post-intervention - 8 weeks)
- TAMPA Scale of Kinesiophobia(baseline)
- TAMPA Scale of Kinesiophobia(post-intervention - 8 weeks)
- Pain Catastrophizing Scale(Baseline)
- Pain Catastrophizing Scale(post-intervention - 8 weeks)
- Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)(baseline)
- Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)(post-intervention - 8 weeks)
- Two-point discrimination(baseline)
- Two-point discrimination(post-intervention - 8 weeks)
- Patient's Global Impression of Change (PGIC)(post-intervention - 8 weeks)
Investigators
Ellen Hirose Pereira Nery
Principal Investigator
Aveiro University