Back Pain Lower Back ChronicPNENCT03964389
Effectiveness of a Psychoeducative Intervention on Patients With Cronic Low Back Pain
A study testing Pain Neuroscience Education" (PNE) in people with Back Pain Lower Back Chronic, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
One of the treatment modalities currently available in this hospital to treat this type of patients with low back pain who present with chronic pain are the group sessions that are carried out to provide information to the patient about the anatomy, biomechanics and ergonomics and are complemented with sessions of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Pain Neuroscience Education" (PNE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2022to 31 Dec 2022
- 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
- Patients participating in the "back protocol" groups in the hospital
- That present pain of more than 3 months of evolution
Who cannot join
- Oncological pain
- Fracture or spinal surgery in the last year
- Cognitive neurological alteration that prevents understanding the contents of the session
- Alterations at the motor level that prevent the realization of the program of directed physical exercise that is currently carried out
- Pregnancy
- Urinary or intestinal incontinence
- Other clinical conditions that may aggravate chronic spinal pain (chronic fatigue syndrome, fibromyalgia and complex regional pain syndrome)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de San Juande Alicante
Sant Joan d'Alacant, Alicante, 03550
About this study
Official title: The Effects of a Single Session of Pain Neuroscience Education (PNE) on Pain and Psychological Factors in Patients With Chronic Low Back Pain. A Double-blind Randomized Clinical Trial
One of the treatment modalities currently available in this hospital to treat this type of patients with low back pain who present with chronic pain are the group sessions that are carried out to provide information to the patient about the anatomy, biomechanics and ergonomics and are complemented with sessions of physical exercise. Based on the latest publications on treatment of this type of patients, The investigators have seen that this intervention is insufficient, and that it could be improved by combining education based on Pain Neuroscience Education (PNE)).
The present study proposes implementing this program to a randomly assigned group of patients participating in the group sessions aimed at patients with lumbar pain called "Back-pain Protocol" that are currently relized in the Physiotherapy Area of a hospital; and compare the results of this intervention with those obtained in another group that will only carry out the sessions with the traditional method that is currently used.
Read the detailed description
Procedure The physiotherapist in charge of the chronic back pain programme group ("back pain protocol") is contacted. The study will be explained and the materials and training to deliver the PNE session will be provided.
Participants who meet the inclusion criteria will then be identified and randomised to the intervention or control group.
At the end of the first session, which currently takes place in group chronic back pain treatment programmes, the physiotherapist will explain the study and ask for cooperation. The information sheet is handed out. Those who decide to participate will receive an informed consent form and some questionnaires to fill in: the Numeric Pain Rating Scale (NPRS) to assess their level of pain, the Central Sensitisation Inventory, the Pain Catastrophic Scale (Spanish version), the Tampa Kinesiofobia Scale (TSK).
Interventions The current protocol consists of five sessions spread over one and a half months. Patients come to the rehabilitation classroom in two groups of 10 people per day for one hour.
The first session consists of an informative talk. The physiotherapist gives information and explanations about the "back pain protocol". The physiotherapist explains the problems of posture and gestures that can be beneficial or detrimental to their treatment, their daily activities, their work and their sporting activities.
In the second, third and fourth sessions, the participants learn specific exercises for back pain. Patients receive a booklet with the exercises and postures to be incorporated into their daily habits.
Treatment. This study proposes that only participants assigned to the intervention group will also receive an additional patient education session on Pain Neuroscience Education (PNE).
This session will last one hour and will be given in an additional session the day after the first information session of the current protocol. They will also be given information to read and review at home. Only patients randomised to the intervention group will attend this session.
The aim of this intervention is to provide participants with information in a clear and simple way, so that they can change their attitude to pain, inviting them to take a more active and less contemplative role. The physiotherapist will explain to the participants in a simple way that chronic pain is not always the result of tissue damage. Neuroscience has shown that it is possible to have persistent pain without tissue damage or with damage that justifies the perception of disproportionate pain. The physiotherapist will also explain the difference between acute and chronic pain, central sensitisation processes (CS) and endogenous pain control mechanisms. The physiotherapist will talk about how thoughts, beliefs and emotions modify the painful experience and how the erroneous information received, sometimes iatrogenic, modifies the mechanisms of pain processing. The content of the neuroscience education lectures is based on the book Explain Pain.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Pain Neuroscience Education" (PNE)
- Keywords
- Central Nervous System Sensitization, kinesiophobia
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience Education" (PNE)Other
Also called Therapeutic Neuroscience Education (TNE)
A lecture on neuroscience education (EN). The aim of this intervention is to provide participants with information in a clear and simple way so that patients can change their attitude to pain, inviting them to take a more active and less contemplative role. Neuroscience has shown that it is possible to have persistent pain without tissue damage or with damage that justifies the perceived disproportion of pain.
| Study group | Role | What they receive |
|---|---|---|
| Intervetion group | Experimental | A sessions of "Pain Neuroscience Education (PNE)" joint a physical exercises programs Receives: Other: Pain Neuroscience Education" (PNE) |
| Control group | No intervention | Only a therapeutic physical exercises programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
Measured: 6 weeks following the reported onset of symptoms.
Secondary outcomes (3)
Pain Catastrophizing: Pain Catastrophizing Scale
Pain Catastrophizing Scale. Catastrophic thinking has widely been recognized in the development and maintenance of hypochondriasis and anxiety disorders.The PCS is a 13 item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). The PCS is broken into three subscales being magnification, rumination, and helplessness. The scale was developed as a self-report measurement tool that provided a valid index of catastrophizing in clinical and non-clinical populations. ranges from '0' representing no pain catastrophizing to '52' representing maximum pain catastrophizing
Measured: baseline, 5 weeks and 12 weeks
Kinesiophobia: Tampa Scale for Kinesiophobia (TSK 11)
Tampa Scale of Kinesiophobia (TSK-11) . It assesses the fear of a patient related with suffering a re-injury again during movement through 11 items. With a score range of 11 to 44, the TSK-11 has demonstrated acceptable internal consistency and validity. A 4-point reduction optimally identifies an significant reduction in the fear of the patient associated with the movement and presents a minimal detectable change of 5.60 points
Measured: baseline, 5 weeks and 12 weeks
- Central sensitisation inventory (CSI)
This instrument is proposed to identify a potential CS syndrome in patients and to assess comorbidities associated with chronic pain, according to the IASP criterio. It contains 25 items scored on a Likert-type scale from 0 to 4. Total score ranges from 0 to 100, with a set cut-off of 40 points to differentiate subjects with and without potential CS or to confirm the presence of pain comorbidities (sensitivity: 85%, specificity: 75%) [32]. Recently, severity ranges have been proposed for CS: subclinical (0-29), mild (30-39), moderate (40-49), severe (50-59) and extreme (60-100).
Measured: baseline, 5 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Jul 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Back Pain Lower Back ChronicStudies 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-armed randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario San Juan de Alicante
- Responsible party
- Principal investigator, María Isabel Tomás Rodríguez, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964389
- Sponsor's protocol ID
- 19/ 317
- Acronym
- PNE
- Status last verified
- Feb 2024
- First submitted
- 13 May 2019
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
PubMed 27351541Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
PubMed 22133255Traeger AC, Lee H, Hubscher M, Skinner IW, Moseley GL, Nicholas MK, Henschke N, Refshauge KM, Blyth FM, Main CJ, Hush JM, Lo S, McAuley JH. Effect of Intensive Patient Education vs Placebo Patient Education on Outcomes in Patients With Acute Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):161-169. doi: 10.1001/jamaneurol.2018.3376.
PubMed 30398542
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Single Session of Pain Neuroscience Education (PNE) on Pain and Psychological Factors in Patients With Chronic Low Back Pain. A Double-blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03964389
- Acronym / sponsor ID
- PNE / 19/ 317
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Central Nervous System Sensitization, kinesiophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Hospital Universitario San Juan de Alicante
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 May 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.
One of the treatment modalities currently available in this hospital to treat this type of patients with low back pain who present with chronic pain are the group sessions that are carried out to provide information to the patient about the anatomy, biomechanics and ergonomics and are complemented with sessions of physical exercise. Based on the latest publications on treatment of this type of patients, The investigators have seen that this intervention is insufficient, and that it could be improved by combining education based on Pain Neuroscience Education (PNE)).
The present study proposes implementing this program to a randomly assigned group of patients participating in the group sessions aimed at patients with lumbar pain called "Back-pain Protocol" that are currently relized in the Physiotherapy Area of a hospital; and compare the results of this intervention with those obtained in another group that will only carry out the sessions with the traditional method that is currently used.
Detailed description
Procedure The physiotherapist in charge of the chronic back pain programme group ("back pain protocol") is contacted. The study will be explained and the materials and training to deliver the PNE session will be provided.
Participants who meet the inclusion criteria will then be identified and randomised to the intervention or control group.
At the end of the first session, which currently takes place in group chronic back pain treatment programmes, the physiotherapist will explain the study and ask for cooperation. The information sheet is handed out. Those who decide to participate will receive an informed consent form and some questionnaires to fill in: the Numeric Pain Rating Scale (NPRS) to assess their level of pain, the Central Sensitisation Inventory, the Pain Catastrophic Scale (Spanish version), the Tampa Kinesiofobia Scale (TSK).
Interventions The current protocol consists of five sessions spread over one and a half months. Patients come to the rehabilitation classroom in two groups of 10 people per day for one hour.
The first session consists of an informative talk. The physiotherapist gives information and explanations about the "back pain protocol". The physiotherapist explains the problems of posture and gestures that can be beneficial or detrimental to their treatment, their daily activities, their work and their sporting activities.
In the second, third and fourth sessions, the participants learn specific exercises for back pain. Patients receive a booklet with the exercises and postures to be incorporated into their daily habits.
Treatment. This study proposes that only participants assigned to the intervention group will also receive an additional patient education session on Pain Neuroscience Education (PNE).
This session will last one hour and will be given in an additional session the day after the first information session of the current protocol. They will also be given information to read and review at home. Only patients randomised to the intervention group will attend this session.
The aim of this intervention is to provide participants with information in a clear and simple way, so that they can change their attitude to pain, inviting them to take a more active and less contemplative role. The physiotherapist will explain to the participants in a simple way that chronic pain is not always the result of tissue damage. Neuroscience has shown that it is possible to have persistent pain without tissue damage or with damage that justifies the perception of disproportionate pain. The physiotherapist will also explain the difference between acute and chronic pain, central sensitisation processes (CS) and endogenous pain control mechanisms. The physiotherapist will talk about how thoughts, beliefs and emotions modify the painful experience and how the erroneous information received, sometimes iatrogenic, modifies the mechanisms of pain processing. The content of the neuroscience education lectures is based on the book Explain Pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two-armed randomized trial
| Arm | Type | Receives |
|---|---|---|
| Intervetion group | Experimental | Other: Pain Neuroscience Education" (PNE)A sessions of "Pain Neuroscience Education (PNE)" joint a physical exercises programs |
| Control group | No intervention | –Only a therapeutic physical exercises programs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients participating in the "back protocol" groups in the hospital
- That present pain of more than 3 months of evolution
Key exclusion criteria (7 listed)
- Oncological pain
- Fracture or spinal surgery in the last year
- Cognitive neurological alteration that prevents understanding the contents of the session
- Alterations at the motor level that prevent the realization of the program of directed physical exercise that is currently carried out
- Pregnancy
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" (PNE)Also: Therapeutic Neuroscience Education (TNE)A lecture on neuroscience education (EN). The aim of this intervention is to provide participants with information in a clear and simple way so that patients can change their attitude to pain, inviting them to take a more active and less contemplative role. Neuroscience has shown that it is possible to have persistent pain without tissue damage or with damage that justifies the perceived disproportion of pain. | Other | Intervetion group |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 6 weeks following the reported onset of symptoms.
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")
3 secondary outcomes
Pain Catastrophizing: Pain Catastrophizing Scale
Time frame: baseline, 5 weeks and 12 weeks
Kinesiophobia: Tampa Scale for Kinesiophobia (TSK 11)
Time frame: baseline, 5 weeks and 12 weeks
- Central sensitisation inventory (CSI)
Time frame: baseline, 5 weeks and 12 weeks
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 6 Feb 2024.
- Background: PubMed 27351541Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
- Background: PubMed 22133255Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
- Background: PubMed 30398542Traeger AC, Lee H, Hubscher M, Skinner IW, Moseley GL, Nicholas MK, Henschke N, Refshauge KM, Blyth FM, Main CJ, Hush JM, Lo S, McAuley JH. Effect of Intensive Patient Education vs Placebo Patient Education on Outcomes in Patients With Acute Low Back Pain: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):161-169. doi: 10.1001/jamaneurol.2018.3376.
- Learn a science based approach to overcome chronic pain.Link provided by the sponsor.
- An international research group that focuses on pain an dody movementLink provided by the sponsor.
- 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" (PNE) in people with Back Pain Lower Back Chronic, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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 7 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 6 Feb 2024. 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 Spain. 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 (NPRS) (time frame: 6 weeks following the reported onset of symptoms.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03964389, which also lists 3 linked publications.
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 6 Feb 2024.