Chronic Low-back PainNCT05953454
Effectiveness of Pain Neuroscience Education on Clinical and Psychosocial Variables in Chronic Low Back Pain
A study testing Pain neuroscience Education in people with Chronic Low-back Pain, run by Universidad Santo Tomas, Chile.
Trial summary
An educational intervention on the neurophysiology of chronic pain will be provided. The content of the intervention will be identical in the experimental groups (group and individual). Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Pain neuroscience Education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 30 Dec 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- non-specific low back pain ≥ 3 months without compromise of any lower limb.
- average pain intensity ≥ 3/10 and ≤8/10 (according to the 0-10 numerical rating scale [NRS]) in the last month.
Who cannot join
- psychiatric, neurological or oncological diseases.
- operated of some lumbar pathology
- chronic low back pain due to a specific cause (lumbar stenosis, herniated disc, spinal deformity, fracture, spondylosis)
- have received any modality of active or passive physical therapy for pain in the last two months,
- previous experiences with PNE
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Group Versus Individual Pain Neuroscience Education on Clinical and Psychosocial Outcomes in Patients With Chronic Low Back Pain: Protocol of a Randomized Controlled Trial
An educational intervention on the neurophysiology of chronic pain will be provided. The content of the intervention will be identical in the experimental groups (group and individual). The intervention has an active educational approach based on reconceptualizing the maladaptive beliefs that influence the fear-avoidance behavior of the participants through updated contents of the neuroscience of pain.
The effects of the intervention will be compared between the groups and the influence of the social determinants of health on the effects will also be determined.
The investigators hypothesize that there will be significant differences in favor of the group intervention group over the individual intervention groups. Furthermore, the effects will be influenced by the social determinants of health in both experimental groups.
- Conditions
- Chronic Low-back Pain
- Being tested
- Pain neuroscience Education
- Keywords
- pain neuroscience education, physical therapy, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience EducationOther
A pain neuroscience education session geared towards fear-avoidance beliefs
| Study group | Role | What they receive |
|---|---|---|
| Group Pain Neuroscience Education | Experimental | A single face-to-face group session of approximately 60-80 minutes provided through active participation. Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation. In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through).
With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain). Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person. This activity must be delivered in the second evaluation. Receives: Other: Pain neuroscience Education |
| Individual Pain Neuroscience Education | Experimental | A single one-on-one face-to-face session of approximately 60-80 minutes provided through active participation. Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation. In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through).
With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain). Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person. This activity must be delivered in the second evaluation. Receives: Other: Pain neuroscience Education |
| Control | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Fear avoidance beliefs
The Fear Avoidance Beliefs Questionnaire consists of two subscales: (1) a 7-item work subscale (FABQ-W) and (2) a 4-item physical activity subscale (FABQ-P). Both subscales score on a Likert-type scale from 0 to 6 points on each item. Higher scores indicate higher levels of fear-avoidance beliefs.
Measured: baseline, 1-week post-intervention, and 4 -weeks post-intervention
changes in pressure pain sensitivity
An algometer will be used to measure pressure pain sensitivity (SPD), which is defined as the amount of applied pressure required for a subject to report the onset of pain sensation. It will be applied three times for each moment of evaluation and the average of the three applications will be considered. The unit of measure kg/cm2/s will be used.
Measured: baseline, 1-week post-intervention, and 4 -weeks post-intervention
Secondary outcomes (4)
Changes in Pain Self-efficacy
Cain self-efficacy questionnaire (PSEQ) consists of 10 items rated on a 7-point Likert scale from 0 ("not at all sure") to 6 ("very sure"). Higher scores indicate stronger self-efficacy beliefs, while low scores indicate a subject more focused on their pain.
Measured: baseline, 1-week post-intervention, and 4 -weeks post-intervention
Changes in Catastrophizing
Pain Catastrophizing Scale (PCS) consists of 13 items on a 5-point Likert scale ranging from (0) never to (4) all the time. Higher scores indicate more catastrophic thoughts.
Measured: baseline, 1-week post-intervention, and 4 -weeks post-intervention
Changes in Pain intensity
Numerical Rating Scale (NRS). It consists of a number line from 0 to 10. Higher scores indicate greater intensity of pain.
Measured: baseline, 1-week post-intervention, and 4 -weeks post-intervention
Treatment expectation
The treatment expectation questionnaire (TEX-Q). This questionnaire consists of 15 questions with a Likert scale of 0-10. higher scores indicate a better expectation of treatment.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Apr 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Santo Tomas, Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joaquín Ignacio Salazar Méndez, Universidad Santo Tomas, Chile
- Investigators
- Joaquín I Salazar, MSc, Principal investigator, Universidad Santo Tomás
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953454
- Sponsor's protocol ID
- USantoTomasChile
- Status last verified
- Jul 2023
- First submitted
- 1 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Group Versus Individual Pain Neuroscience Education on Clinical and Psychosocial Outcomes in Patients With Chronic Low Back Pain: Protocol of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05953454
- Acronym / sponsor ID
- USantoTomasChile
- Conditions
- Chronic Low-back Pain
- Keywords
- pain neuroscience education, physical therapy, chronic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Universidad Santo Tomas, ChileUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 20 Jul 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.
An educational intervention on the neurophysiology of chronic pain will be provided. The content of the intervention will be identical in the experimental groups (group and individual). The intervention has an active educational approach based on reconceptualizing the maladaptive beliefs that influence the fear-avoidance behavior of the participants through updated contents of the neuroscience of pain.
The effects of the intervention will be compared between the groups and the influence of the social determinants of health on the effects will also be determined.
The investigators hypothesize that there will be significant differences in favor of the group intervention group over the individual intervention groups. Furthermore, the effects will be influenced by the social determinants of health in both experimental groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Pain Neuroscience Education | Experimental | Other: Pain neuroscience EducationA single face-to-face group session of approximately 60-80 minutes provided through active participation. Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation. In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through). With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain). Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person. This activity must be delivered in the second evaluation. |
| Individual Pain Neuroscience Education | Experimental | Other: Pain neuroscience EducationA single one-on-one face-to-face session of approximately 60-80 minutes provided through active participation. Five key domains will be structured from the Fear and Belief Avoidance Questionnaire that will serve as a guide for the sessions through a Powerpoint presentation. In addition, participants will be encouraged to be active by walking for 20-30 minutes 3-5 times a week and will be taught an exercise to improve transverse abdominis activation (abdominal corset or follow-through). With the main ones, a brochure will be delivered and informative capsules will be made to which the participants will have access (5 videos of 15 minutes, one per domain). Participants will be instructed to record on a calendar the days they read the brochure and/or reviewed the information capsules to assess treatment compliance and for each domain invent a metaphor or script for how they would explain it to another person. This activity must be delivered in the second evaluation. |
| Control | No intervention | –no intervention |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- non-specific low back pain ≥ 3 months without compromise of any lower limb.
- average pain intensity ≥ 3/10 and ≤8/10 (according to the 0-10 numerical rating scale [NRS]) in the last month.
Key exclusion criteria (5 listed)
- psychiatric, neurological or oncological diseases.
- operated of some lumbar pathology
- chronic low back pain due to a specific cause (lumbar stenosis, herniated disc, spinal deformity, fracture, spondylosis)
- have received any modality of active or passive physical therapy for pain in the last two months,
- previous experiences with PNE
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 EducationA pain neuroscience education session geared towards fear-avoidance beliefs | Other | Group Pain Neuroscience Education, Individual Pain Neuroscience Education |
Primary outcome
Changes in Fear avoidance beliefs
Time frame: baseline, 1-week post-intervention, and 4 -weeks post-intervention
The Fear Avoidance Beliefs Questionnaire consists of two subscales: (1) a 7-item work subscale (FABQ-W) and (2) a 4-item physical activity subscale (FABQ-P). Both subscales score on a Likert-type scale from 0 to 6 points on each item. Higher scores indicate higher levels of fear-avoidance beliefs.
changes in pressure pain sensitivity
Time frame: baseline, 1-week post-intervention, and 4 -weeks post-intervention
An algometer will be used to measure pressure pain sensitivity (SPD), which is defined as the amount of applied pressure required for a subject to report the onset of pain sensation. It will be applied three times for each moment of evaluation and the average of the three applications will be considered. The unit of measure kg/cm2/s will be used.
4 secondary outcomes
Changes in Pain Self-efficacy
Time frame: baseline, 1-week post-intervention, and 4 -weeks post-intervention
Changes in Catastrophizing
Time frame: baseline, 1-week post-intervention, and 4 -weeks post-intervention
Changes in Pain intensity
Time frame: baseline, 1-week post-intervention, and 4 -weeks post-intervention
Treatment expectation
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
Related trials for Chronic Low-back Pain
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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.
Joaquín I Salazar, MSc principal investigator
Universidad Santo Tomás
Questions about this trial
What is this clinical trial studying?
A study testing Pain neuroscience Education in people with Chronic Low-back Pain, run by Universidad Santo Tomas, Chile.
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 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: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquín I Salazar, MSc (+569 73785287, jsalazar13@santotomas.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Fear avoidance beliefs (time frame: baseline, 1-week post-intervention, and 4 -weeks post-intervention). The study lists 2 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 20 Jul 2023.