Low Back PainNCT04191317
Pain Neuroscience Education and Gradual Exposure to Exercise in Factory Workers With Chronic Low Back Pain
A study testing Pain Neuroscience Education and gradual exposure and Pilates and postural education in people with Low Back Pain, run by Aveiro University at 1 site in Portugal.
Trial summary
This study aims to compare the effectiveness of a pain neuroscience education (PNE) based programe and gradual exposure to exercise versus pilates on disability levels associated with chronic low back pain in factory workers. There will be two arms each one receiving one type of intervention over 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Pain Neuroscience Education and gradual exposure and Pilates and postural education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Dec 2019to 30 Jul 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to have nonspecific low back pain lasting longer than three months, felt in the anatomic region below the costal margin and above the inferior gluteal folds, without referred leg pain and not related to any specific pathology such as lumbar fracture, ankylosing spondylitis, cauda equina syndrome, infection or tumour;
- not receiving treatment for low back pain.
Who cannot join
- altered sensorial signs indicative of radiculopathy; red flags such as weight loss without a particular cause, cancer diagnosis or sustained use of corticoids;
- presence of any rheumatic, neurologic or cardiorespiratory disease that prevent the practice of physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to compare the effectiveness of a pain neuroscience education (PNE) based programe and gradual exposure to exercise versus pilates on disability levels associated with chronic low back pain in factory workers. There will be two arms each one receiving one type of intervention over 8 weeks.
Read the detailed description
This will be a pilot randomized controlled and experimental study. There will be two groups, one group will receive an intervention strategy based in basic postural re-education exercises (Pilates) and self-management strategies, and the other group will perform a program based in pain neuroscience education and gradual exposure to exercise. Both interventions will be delivered in the physiotherapy office of a paper industry. Participants will be randomly allocated according to the work team they belong, to an intervention arm.
The inclusion criteria to participate in the study are: to have nonspecific low back pain lasting longer than three months, felt in the anatomic region below the costal margin and above the inferior gluteal folds, without referred leg pain and not related to any specific pathology such as lumbar fracture, ankylosing spondylitis, cauda equina syndrome, infection or tumour and not receiving treatment for low back pain. Participants will be excluded if during the physical examination they show altered sensorial signs indicative of radiculopathy; red flags such as weight loss without a particular cause, cancer diagnosis or sustained use of corticoids; presence of any rheumatic, neurologic or cardiorespiratory disease that prevent the practice of physical exercise.
Once inclusion criteria have been ascertained, participants will be assessed for sociodemographic and anthropometric data, pain, disability, knowledge of pain neurophysiology, pain catastrophizing, fear of movement, presence of a neuropathic component, workstation evaluation and global impression of change related to intervention.
The intervention will last for 8 weeks, during which participants will have 1 face-to-face session per week with a duration of approximately 60 minutes each. One group (Pilates group) will receive an intervention based on Pilates' and and postural education. The other group will have theoretical sessions of PNE and gradual exposure to exercise (PNE plus graded exposure group).
- Conditions
- Low Back Pain
- Being tested
- Pain Neuroscience Education and gradual exposure, Pilates and postural education
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education and gradual exposureOther
Education covering the pathophysiology of apin and exercises based on the gradual exposure principle
Pilates and postural educationOther
Postural education and pilates exercises
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education and gradual exposure | Experimental | Education explaining the neurophysiological processes that lead to chronic pain, in order to change maladaptive belief towards disease, reconceptualising them and desensitizing the Central Nervous system.
On first session of gradual exposure the patients are challenged to create a hierarchically list with the functional activities they experience fear, and exposure begins with the one they have less. Both the therapist and participant will determine a specific group of exercises after the patient understands the benign nature of pain, and will be evaluated the maximal performance of the individual to perform each exercise separately. Receives: Other: Pain Neuroscience Education and gradual exposure |
| Pilates and postural education | Active comparator | In the first session, basic Pilates principles will be taught and reinforced at the beginning of the follow up sessions, including: postural alignment (neutral spine position, shoulder blade and neck position) and core recruitment along with a controlled breathing. Each session will have a warm up, mobility, stability and strengthening exercises and a cool down period. Receives: Other: Pilates and postural education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Measured using the Numerical Rating Scale (NRS), a 11-point scale is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: Baseline (week 0)
Pain intensity
Measured using the Numerical Rating Scale (NRS), a 11-point scale is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: End of study - week 9
Pain intensity
Measured using the Numerical Rating Scale (NRS), a 11-point scale is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable)
Measured: 3 months follow up
Secondary outcomes (18)
Disability
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Measured: Baseline (week 0)
Disability
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Measured: End of study - week 9
Disability
Measured using the Roland Morris Disability Questionnaire, scored a minimum of 0 and a maximum of 24
Measured: 3 months follow up
Knowledge of pain neurophysiology
Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19
Measured: Baseline - week 0
Knowledge of pain neurophysiology
Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19
Measured: End of study - week 9
Knowledge of pain neurophysiology
Measured using the Neurophysiology of Pain Questionnaire scored a minimum of 0 and a maximum of 19
Measured: 3 months follow up
Pain catastrophizing
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Measured: Baseline - week 0
Pain catastrophizing
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Measured: End of study - week 9
Pain catastrophizing
Measured using the Pain Catastrophizing Scale scored a minimum of 0 and a maximum of 52
Measured: 3 months follow up
Fear avoidance behavior
Measured using the Tampa Scale of Kinesiophobia, total score varies from 13 to 52, where 13 represents the less and 52 the greater level of fear of movement
Measured: Baseline - week 0
Fear avoidance behavior
Measured using the Tampa Scale of Kinesiophobia, total score varies from 13 to 52, where 13 represents the less and 52 the greater level of fear of movement
Measured: End of study - week 9
Fear avoidance behavior
Measured using the Tampa Scale of Kinesiophobia, total score varies from 13 to 52, where 13 represents the less and 52 the greater level of fear of movement
Measured: 3 months follow up
Pain phenotype
Measured using the Pain Detect Questionnaire. Total score varies from -1 to 38 points. Scores below 12 indicate little probability of a neuropathic component (85% chance of not having); scores between 12 - 19 reveal a mixed phenotype, whereas a score above 19 reveals high probability of neuropathic pain (90% chance).
Measured: Baseline - week 0
Pain phenotype
Measured using the Pain Detect Questionnaire. Total score varies from -1 to 38 points. Scores below 12 indicate little probability of a neuropathic component (85% chance of not having); scores between 12 - 19 reveal a mixed phenotype, whereas a score above 19 reveals high probability of neuropathic pain (90% chance).
Measured: End of study - week 9
Pain phenotype
Measured using the Pain Detect Questionnaire. Total score varies from -1 to 38 points. Scores below 12 indicate little probability of a neuropathic component (85% chance of not having); scores between 12 - 19 reveal a mixed phenotype, whereas a score above 19 reveals high probability of neuropathic pain (90% chance).
Measured: 3 months follow up
Patient Global Impression of Change
Measured using the Patient Global Impression of Change (PGIC) scale. This is a unidimensional measure widely used in chronic pain studies, in which the patients classify their improvements using a 7-point scale, varying from "1- no change" to "7 - a great deal better and a considerable improvement that has made all the difference"
Measured: Baseline - week 0
Patient Global Impression of Change
Measured using the Patient Global Impression of Change (PGIC) scale. This is a unidimensional measure widely used in chronic pain studies, in which the patients classify their improvements using a 7-point scale, varying from "1- no change" to "7 - a great deal better and a considerable improvement that has made all the difference"
Measured: End of study - week 9
Patient Global Impression of Change
Measured using the Patient Global Impression of Change (PGIC) scale. This is a unidimensional measure widely used in chronic pain studies, in which the patients classify their improvements using a 7-point scale, varying from "1- no change" to "7 - a great deal better and a considerable improvement that has made all the difference"
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 posted9 Dec 2019
- Study start2 Dec 2019
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Two arms, each receiving a different intervention.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191317
- Sponsor's protocol ID
- 21-CED/2019
- Status last verified
- Jul 2022
- First submitted
- 5 Dec 2019
- Last updated
- 15 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education and Gradual Exposure to Exercise in Factory Workers With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04191317
- Acronym / sponsor ID
- 21-CED/2019
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 9 Dec 2019 (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 to compare the effectiveness of a pain neuroscience education (PNE) based programe and gradual exposure to exercise versus pilates on disability levels associated with chronic low back pain in factory workers. There will be two arms each one receiving one type of intervention over 8 weeks.
Detailed description
This will be a pilot randomized controlled and experimental study. There will be two groups, one group will receive an intervention strategy based in basic postural re-education exercises (Pilates) and self-management strategies, and the other group will perform a program based in pain neuroscience education and gradual exposure to exercise. Both interventions will be delivered in the physiotherapy office of a paper industry. Participants will be randomly allocated according to the work team they belong, to an intervention arm.
The inclusion criteria to participate in the study are: to have nonspecific low back pain lasting longer than three months, felt in the anatomic region below the costal margin and above the inferior gluteal folds, without referred leg pain and not related to any specific pathology such as lumbar fracture, ankylosing spondylitis, cauda equina syndrome, infection or tumour and not receiving treatment for low back pain. Participants will be excluded if during the physical examination they show altered sensorial signs indicative of radiculopathy; red flags such as weight loss without a particular cause, cancer diagnosis or sustained use of corticoids; presence of any rheumatic, neurologic or cardiorespiratory disease that prevent the practice of physical exercise.
Once inclusion criteria have been ascertained, participants will be assessed for sociodemographic and anthropometric data, pain, disability, knowledge of pain neurophysiology, pain catastrophizing, fear of movement, presence of a neuropathic component, workstation evaluation and global impression of change related to intervention.
The intervention will last for 8 weeks, during which participants will have 1 face-to-face session per week with a duration of approximately 60 minutes each. One group (Pilates group) will receive an intervention based on Pilates' and and postural education. The other group will have theoretical sessions of PNE and gradual exposure to exercise (PNE plus graded exposure group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two arms, each receiving a different intervention.
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education and gradual exposure | Experimental | Other: Pain Neuroscience Education and gradual exposureEducation explaining the neurophysiological processes that lead to chronic pain, in order to change maladaptive belief towards disease, reconceptualising them and desensitizing the Central Nervous system. On first session of gradual exposure the patients are challenged to create a hierarchically list with the functional activities they experience fear, and exposure begins with the one they have less. Both the therapist and participant will determine a specific group of exercises after the patient understands the benign nature of pain, and will be evaluated the maximal performance of the individual to perform each exercise separately. |
| Pilates and postural education | Active comparator | Other: Pilates and postural educationIn the first session, basic Pilates principles will be taught and reinforced at the beginning of the follow up sessions, including: postural alignment (neutral spine position, shoulder blade and neck position) and core recruitment along with a controlled breathing. Each session will have a warm up, mobility, stability and strengthening exercises and a cool down period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- to have nonspecific low back pain lasting longer than three months, felt in the anatomic region below the costal margin and above the inferior gluteal folds, without referred leg pain and not related to any specific pathology such as lumbar fracture, ankylosing spondylitis, cauda equina syndrome, infection or tumour;
- not receiving treatment for low back pain.
Key exclusion criteria (2 listed)
- altered sensorial signs indicative of radiculopathy; red flags such as weight loss without a particular cause, cancer diagnosis or sustained use of corticoids;
- presence of any rheumatic, neurologic or cardiorespiratory disease that prevent the practice of physical exercise.
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 |
|---|---|---|
| Pain Neuroscience Education and gradual exposureEducation covering the pathophysiology of apin and exercises based on the gradual exposure principle | Other | Pain Neuroscience Education and gradual exposure |
| Pilates and postural educationPostural education and pilates exercises | Other | Pilates and postural education |
Primary outcome
Pain intensity
Time frame: Baseline (week 0)
Measured using the Numerical Rating Scale (NRS), a 11-point scale is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable)
Pain intensity
Time frame: End of study - week 9
Measured using the Numerical Rating Scale (NRS), a 11-point scale is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable)
Pain intensity
Time frame: 3 months follow up
Measured using the Numerical Rating Scale (NRS), a 11-point scale is a measure of pain in which patients rate their pain ranging from 0 (no pain) to 10 (worst pain imaginable)
18 secondary outcomes
Disability
Time frame: Baseline (week 0)
Disability
Time frame: End of study - week 9
Disability
Time frame: 3 months follow up
Knowledge of pain neurophysiology
Time frame: Baseline - week 0
Knowledge of pain neurophysiology
Time frame: End of study - week 9
Knowledge of pain neurophysiology
Time frame: 3 months follow up
Pain catastrophizing
Time frame: Baseline - week 0
Pain catastrophizing
Time frame: End of study - week 9
Pain catastrophizing
Time frame: 3 months follow up
Fear avoidance behavior
Time frame: Baseline - week 0
Fear avoidance behavior
Time frame: End of study - week 9
Fear avoidance behavior
Time frame: 3 months follow up
Pain phenotype
Time frame: Baseline - week 0
Pain phenotype
Time frame: End of study - week 9
Pain phenotype
Time frame: 3 months follow up
Patient Global Impression of Change
Time frame: Baseline - week 0
Patient Global Impression of Change
Time frame: End of study - week 9
Patient Global Impression of Change
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 15 Jul 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience Education and gradual exposure and Pilates and postural education in people with 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 2 inclusion and 2 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 15 Jul 2022. 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?
Pain intensity (time frame: Baseline (week 0)). 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 15 Jul 2022.