Low Back PainNCT03409562
Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Unspecific Low Back Pain
A study testing pain neurophysiology education in people with Low Back Pain, run by Universidad Complutense de Madrid at 2 sites in Spain.
Trial summary
The purpose of the present study is to evaluate whether the addition of two pain neurophysiology education sessions to motor control training may result in an improvement of the outcome measures of pain and disability, compared to motor control training alone. 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 neurophysiology education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Feb 2018to 9 Jun 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
- Unspecific low back pain for at least 3 months
- Patients must be knowledgeable in the language in which the educational sessions will be provided (Spanish)
Who cannot join
- Specific low back pain (e.g. infection, tumor, fracture, radiculopathy).
- Signs and symptoms of neuropathic pain or generalized chronic pain.
- History of lumbar or cervical spine surgery.
- Pregnancy.
- Concomitant pathologies that impede the performance of exercises.
- Psychiatric treatment.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Hospital Clínico San Carlos
Madrid, 28040
About this study
Official title: Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Patients With Unspecific Low Back Pain
The purpose of the present study is to evaluate whether the addition of two pain neurophysiology education sessions to motor control training may result in an improvement of the outcome measures of pain and disability, compared to motor control training alone.
Read the detailed description
Sixty-two subjects with unspecific low-back pain were randomly recruited for the present study. The subjects were randomly allocated to a control group (which received only motor control training) and an intervention group (which underwent two pain neurophysiology education sessions prior to motor control training). Primary outcome measures were pain (measured with the Visual Analogical Scale) and disability (measured with the Oswestry Disability Index). Secondary outcome measures are kinesiophobia (Tampa Scale for Kinesiophobia), the global perceived effect (Global Perceived Effect Scale) and quality of life (SF-12). These will be measured before the intervention, at the end of the intervention, and 3 and 6 months after ending the intervention.
- Conditions
- Low Back Pain
- Being tested
- motor control training, pain neurophysiology education
- Keywords
- low back pain, pain neurophysiology education, motor control
- 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.
motor control trainingBehavioural
Exercises to strengthen the lumbar musculature and control the posture.
pain neurophysiology educationBehavioural
Also called pain neuroscience education
Educational sessions to improve patient's neurophysiology of pain knowledge.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neurophysiology Education and motor control training | Experimental | This group will undergo two pain neurophysiology education sessions prior to motor control training. Receives: Behavioral: motor control training; Behavioral: pain neurophysiology education |
| motor control training alone | Active comparator | This group will only perform motor control training. Receives: Behavioral: motor control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain at different time points
Visual Analogic Scale
Measured: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
Change in disability at different time points
Oswestry Disability Index
Measured: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
Secondary outcomes (3)
Change in kinesiophobia at different time points
Tampa Scale of Kinesiophobia
Measured: Assessed before the intervention, at the end of the 4-week intervention and 3 and 6 months after the end of the intervention
Change in Global Perceived Effect at different time points
Global Perceived Effect Scale
Measured: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
Change in quality of life at different time points
SF-12 questionnaire
Measured: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start14 Feb 2018
- Primary completion3 May 2021
- Study completion9 Jun 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.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Fundación Alcorcón, FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
- Responsible party
- Principal investigator, Gustavo Plaza Manzano, Universidad Complutense de Madrid
- Investigators
- Gustavo Plaza-Manzano, Ph.D, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409562
- Sponsor's protocol ID
- CI 17/108
- Other IDs
- 18/068-E
- Status last verified
- Jun 2022
- First submitted
- 10 Jan 2018
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Patients With Unspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT03409562
- Acronym / sponsor ID
- CI 17/108
- Conditions
- Low Back Pain
- Keywords
- low back pain, pain neurophysiology education, motor control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Hospital Universitario Fundación Alcorcón, FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 3 May 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 24 Jan 2018 (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.
The purpose of the present study is to evaluate whether the addition of two pain neurophysiology education sessions to motor control training may result in an improvement of the outcome measures of pain and disability, compared to motor control training alone.
Detailed description
Sixty-two subjects with unspecific low-back pain were randomly recruited for the present study. The subjects were randomly allocated to a control group (which received only motor control training) and an intervention group (which underwent two pain neurophysiology education sessions prior to motor control training). Primary outcome measures were pain (measured with the Visual Analogical Scale) and disability (measured with the Oswestry Disability Index). Secondary outcome measures are kinesiophobia (Tampa Scale for Kinesiophobia), the global perceived effect (Global Perceived Effect Scale) and quality of life (SF-12). These will be measured before the intervention, at the end of the intervention, and 3 and 6 months after ending the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Neurophysiology Education and motor control training | Experimental | Behavioral: motor control training, Behavioral: pain neurophysiology educationThis group will undergo two pain neurophysiology education sessions prior to motor control training. |
| motor control training alone | Active comparator | Behavioral: motor control trainingThis group will only perform motor control training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unspecific low back pain for at least 3 months
- Patients must be knowledgeable in the language in which the educational sessions will be provided (Spanish)
Key exclusion criteria (6 listed)
- Specific low back pain (e.g. infection, tumor, fracture, radiculopathy).
- Signs and symptoms of neuropathic pain or generalized chronic pain.
- History of lumbar or cervical spine surgery.
- Pregnancy.
- Concomitant pathologies that impede the performance of exercises.
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 |
|---|---|---|
| motor control trainingExercises to strengthen the lumbar musculature and control the posture. | Behavioural | Pain Neurophysiology Education and motor control training, motor control training alone |
| pain neurophysiology educationAlso: pain neuroscience educationEducational sessions to improve patient's neurophysiology of pain knowledge. | Behavioural | Pain Neurophysiology Education and motor control training |
Primary outcome
Change in pain at different time points
Time frame: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
Visual Analogic Scale
Change in disability at different time points
Time frame: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
Oswestry Disability Index
3 secondary outcomes
Change in kinesiophobia at different time points
Time frame: Assessed before the intervention, at the end of the 4-week intervention and 3 and 6 months after the end of the intervention
Change in Global Perceived Effect at different time points
Time frame: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
Change in quality of life at different time points
Time frame: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention
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 5 Jul 2022.
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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.
Gustavo Plaza-Manzano, Ph.D study director
Universidad Complutense de Madrid
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pain neurophysiology education in people with Low Back Pain, run by Universidad Complutense de Madrid at 2 sites 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 6 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 5 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 2 sites 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?
Change in pain at different time points (time frame: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the 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 5 Jul 2022.