Chronic Low-back PainNCT05777343
Exercise, PNE and Cognitive Training in Individuals With Chronic Low Back Pain
A study testing Experimental, Exercise and PNE and Cognitive training in people with Chronic Low-back Pain, run by Aveiro University at 1 site in Portugal.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Experimental, Exercise and PNE and Cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Apr 2023to 15 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Neuroscience Education, Exercise, and Cognitive Training in Individuals With Idiopathic Chronic Low Back Pain: a Three-arm Randomized Trial
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).
Read the 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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Experimental, Exercise and PNE, Cognitive training
- Keywords
- cognitive training, exercise, chronic low back pain, pain neuroscience education
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Cognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
Exercise and PNEOther
Recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education).
Cognitive trainingOther
Online sessions of cognitive training.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | Participants will receive exercise, PNE and online cognitive training sessions. Receives: Other: Experimental |
| Intervention 2 | Active comparator | Participants will receive exercise and pain neuroscience education (PNE). Receives: Other: Exercise and PNE |
| Intervention 3 | Active comparator | Participants will receive online cognitive training sessions. Receives: Other: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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".
Measured: 3 months follow-up
Secondary outcomes (26)
Cognitive Function
Cognitive function will be assessed using the Brain on Track® (BoT), a self-administered computerized test that evaluates different cognitive domains. Each test has a virtually unlimited range score and considers the maximum number of correct answers that a person gives in a fixed period of time and higher scores represent higher cognitive performance.
Measured: baseline
Cognitive Function
Cognitive function will be assessed using the Brain on Track® (BoT), a self-administered computerized test that evaluates different cognitive domains. Each test has a virtually unlimited range score and considers the maximum number of correct answers that a person gives in a fixed period of time and higher scores represent higher cognitive performance.
Measured: post-intervention - 8 weeks
Cognitive Function
Cognitive function will be assessed using the Brain on Track® (BoT), a self-administered computerized test that evaluates different cognitive domains. Each test has a virtually unlimited range score and considers the maximum number of correct answers that a person gives in a fixed period of time and higher scores represent higher cognitive performance.
Measured: 3 months follow-up.
Roland Morris disability questionnaire
The Roland Morris assesses disability caused by LBP. It has 24 statements, and the individual must tick those that relate to him that day. The total score ranges from "0" meaning no disability to "24" meaning maximum disability.
Measured: baseline
Roland Morris disability questionnaire
The Roland Morris assesses disability caused by LBP. It has 24 statements, and the individual must tick those that relate to him that day. The total score ranges from "0" meaning no disability to "24" meaning maximum disability.
Measured: post-intervention - 8 weeks
Roland Morris disability questionnaire
The Roland Morris assesses disability caused by LBP. It has 24 statements, and the individual must tick those that relate to him that day. The total score ranges from "0" meaning no disability to "24" meaning maximum disability.
Measured: 3 months follow-up
Central sensitization Inventory
The central sensitization inventory (CSI) assesses symptoms of central sensitization. The total score ranges from 0 to 100 points and to identify central sensitization in individuals, the recommended cut-off score is 40 points.
Measured: baseline
Central sensitization Inventory
The central sensitization inventory (CSI) assesses symptoms of central sensitization. The total score ranges from 0 to 100 points and to identify central sensitization in individuals, the recommended cut-off score is 40 points.
Measured: post-intervention - 8 weeks
Central sensitization Inventory
The central sensitization inventory (CSI)assesses symptoms of central sensitization. The total score ranges from 0 to 100 points and to identify central sensitization in individuals, the recommended cut-off score is 40 points.
Measured: 3 months follow-up
Hospital Anxiety and Depression Scale (HADS)
HADS evaluates symptoms of anxiety and depression. The total scores range from 0 to 21 points with a 4-point Likert scale rating between "most of the times" and "not at all" with higher scores indicating higher levels of anxiety and depression.
Measured: baseline
Hospital Anxiety and Depression Scale (HADS)
HADS evaluates symptoms of anxiety and depression. The total scores range from 0 to 21 points with a 4-point Likert scale rating between "most of the times" and "not at all" with higher scores indicating higher levels of anxiety and depression.
Measured: post-intervention - 8 weeks
Hospital Anxiety and Depression Scale (HADS)
HADS evaluates symptoms of anxiety and depression. The total scores range from 0 to 21 points with a 4-point Likert scale rating between "most of the times" and "not at all" with higher scores indicating higher levels of anxiety and depression.
Measured: 3 months follow-up.
TAMPA Scale of Kinesiophobia
The Tampa scale measures the fear of movement related to chronic LBP. The short version has 13 items in a 4-point Likert scale rating between "strongly disagree" and "strongly agree". The total scores range from 0 to 52 points with higher levels indicating higher fear of movement.
Measured: baseline
TAMPA Scale of Kinesiophobia
The Tampa scale measures the fear of movement related to chronic LBP. The short version has 13 items in a 4-point Likert scale rating between "strongly disagree" and "strongly agree". The total scores range from 0 to 52 points with higher levels indicating higher fear of movement.
Measured: post-intervention - 8 weeks
TAMPA Scale of Kinesiophobia
The Tampa scale measures the fear of movement related to chronic LBP. The short version has 13 items in a 4-point Likert scale rating between "strongly disagree" and "strongly agree". The total scores range from 0 to 52 points with higher levels indicating higher fear of movement.
Measured: 3 months follow-up.
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) assess catastrophic thinking related to pain. It has 13 statements on a 5-point scale ranging from 0 meaning "not at all" and 4 meaning "all the time". The total score ranges from 0 to 52 with higher scores indicating higher levels of catastrophizing.
Measured: Baseline
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) assess catastrophic thinking related to pain. It has 13 statements on a 5-point scale ranging from 0 meaning "not at all" and 4 meaning "all the time". The total score ranges from 0 to 52 with higher scores indicating higher levels of catastrophizing.
Measured: post-intervention - 8 weeks
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) assess catastrophic thinking related to pain. It has 13 statements on a 5-point scale ranging from 0 meaning "not at all" and 4 meaning "all the time". The total score ranges from 0 to 52 with higher scores indicating higher levels of catastrophizing.
Measured: 3 months follow-up.
Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
The scale assess the difficulties with sleep onset and maintenance and the quality and depth of sleep during the last month and considering a normal week. Total score ranges from 0 to 28 points and higher scores are associated with poor quality of sleep.
Measured: baseline
Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
The scale assess the difficulties with sleep onset and maintenance and the quality and depth of sleep during the last month and considering a normal week. Total score ranges from 0 to 28 points and higher scores are associated with poor quality of sleep.
Measured: post-intervention - 8 weeks
Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
The scale assess the difficulties with sleep onset and maintenance and the quality and depth of sleep during the last month and considering a normal week. Total score ranges from 0 to 28 points and higher scores are associated with poor quality of sleep.
Measured: 3 months follow-up.
Two-point discrimination
Two-point discrimination is used to assess cortical reorganization.
Measured: baseline
Two-point discrimination
Two-point discrimination is used to assess cortical reorganization.
Measured: post-intervention - 8 weeks
Two-point discrimination
Two-point discrimination is used to assess cortical reorganization.
Measured: 3 months follow-up
Patient's Global Impression of Change (PGIC)
PGIC evaluates the perception of improvement associated with the intervention. Participants are instructed to select on a scale from 1 ("No change or condition worsened") to 7 ("Much better, and with a considerable improvement that made all the difference") the statement that best reflected the impact of the intervention on their condition.
Measured: post-intervention - 8 weeks
Patient's Global Impression of Change (PGIC)
PGIC evaluates the perception of improvement associated with the intervention. Participants are instructed to select on a scale from 1 ("No change or condition worsened") to 7 ("Much better, and with a considerable improvement that made all the difference") the statement that best reflected the impact of the intervention on their condition.
Measured: 3 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start10 Apr 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel randomized trial. Participants were randomly allocated in one of three groups: cognitive training alone; pain science education combined with exercise; or pain science education, exercise and cognitive training. Allocation was performed using block randomization generated with an online randomization tool by a researcher not involved in recruitment, assessment or delivery of the interventions. Interventions lasted eight weeks and were delivered in three consecutive cohorts, with all three groups represented in each cohort.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, RISE Study Group
- Responsible party
- Principal investigator, Ellen Hirose Pereira Nery, Aveiro University
- Investigators
- Anabela Silva, PhD, Study director, School of Health Sciences, University of Aveiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05777343
- Sponsor's protocol ID
- RCTCognitiveTraining
- Status last verified
- Sep 2026
- First submitted
- 23 Feb 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not publicly available due to ethical and privacy restrictions of the approved study protocol. An anonymized analysis dataset may be made available to qualified researchers upon reasonable request to the principal investigator and subject to approval by the Ethics and Deontology Council of the University of Aveiro.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education, Exercise, and Cognitive Training in Individuals With Idiopathic Chronic Low Back Pain: a Three-arm Randomized Trial
- ClinicalTrials.gov ID
- NCT05777343
- Acronym / sponsor ID
- RCTCognitiveTraining
- Conditions
- Chronic Low-back Pain
- Keywords
- cognitive training, exercise, chronic low back pain, pain neuroscience education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, RISE Study Group
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel randomized trial. Participants were randomly allocated in one of three groups: cognitive training alone; pain science education combined with exercise; or pain science education, exercise and cognitive training. Allocation was performed using block randomization generated with an online randomization tool by a researcher not involved in recruitment, assessment or delivery of the interventions. Interventions lasted eight weeks and were delivered in three consecutive cohorts, with all three groups represented in each cohort.
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Other: ExperimentalParticipants will receive exercise, PNE and online cognitive training sessions. |
| Intervention 2 | Active comparator | Other: Exercise and PNEParticipants will receive exercise and pain neuroscience education (PNE). |
| Intervention 3 | Active comparator | Other: Cognitive trainingParticipants will receive online cognitive training sessions. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalCognitive training combined with the recommended non-pharmacological intervention (Exercise and Pain Neuroscience Education). | Other | Intervention 1 |
| Exercise and PNERecommended non-pharmacological intervention (Exercise and Pain Neuroscience Education). | Other | Intervention 2 |
| Cognitive trainingOnline sessions of cognitive training. | Other | Intervention 3 |
Primary outcome
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".
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".
26 secondary outcomes
Cognitive Function
Time frame: baseline
Cognitive Function
Time frame: post-intervention - 8 weeks
Cognitive Function
Time frame: 3 months follow-up.
Roland Morris disability questionnaire
Time frame: baseline
Roland Morris disability questionnaire
Time frame: post-intervention - 8 weeks
Roland Morris disability questionnaire
Time frame: 3 months follow-up
Central sensitization Inventory
Time frame: baseline
Central sensitization Inventory
Time frame: post-intervention - 8 weeks
Central sensitization Inventory
Time frame: 3 months follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: baseline
Hospital Anxiety and Depression Scale (HADS)
Time frame: post-intervention - 8 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months follow-up.
TAMPA Scale of Kinesiophobia
Time frame: baseline
TAMPA Scale of Kinesiophobia
Time frame: post-intervention - 8 weeks
TAMPA Scale of Kinesiophobia
Time frame: 3 months follow-up.
Pain Catastrophizing Scale
Time frame: Baseline
Pain Catastrophizing Scale
Time frame: post-intervention - 8 weeks
Pain Catastrophizing Scale
Time frame: 3 months follow-up.
Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
Time frame: baseline
Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
Time frame: post-intervention - 8 weeks
Basic Scale on Insomnia Complaints and Quality of Sleep (BaSIQs)
Time frame: 3 months follow-up.
Two-point discrimination
Time frame: baseline
Two-point discrimination
Time frame: post-intervention - 8 weeks
Two-point discrimination
Time frame: 3 months follow-up
Patient's Global Impression of Change (PGIC)
Time frame: post-intervention - 8 weeks
Patient's Global Impression of Change (PGIC)
Time frame: 3 months follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data are not publicly available due to ethical and privacy restrictions of the approved study protocol. An anonymized analysis dataset may be made available to qualified researchers upon reasonable request to the principal investigator and subject to approval by the Ethics and Deontology Council of the University of Aveiro.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anabela Silva, PhD study director
School of Health Sciences, University of Aveiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental, Exercise and PNE and Cognitive training in people with Chronic Low-back Pain, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale Numeric Pain Rating Scale (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.