Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Unspecific Low Back Pain

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Patients With Unspecific Low Back Pain

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: motor control training
* Behavioral: pain neurophysiology education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Neurophysiology Education and motor control training<br>This group will undergo two pain neurophysiology education sessions prior to motor control training. | Behavioral: motor control training<br>* Exercises to strengthen the lumbar musculature and control the posture.<br>Behavioral: pain neurophysiology education<br>* Educational sessions to improve patient's neurophysiology of pain knowledge.<br>* Other names: pain neuroscience education;|
| Active Comparator: motor control training alone<br>This group will only perform motor control training. | Behavioral: motor control training<br>* Exercises to strengthen the lumbar musculature and control the posture.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain at different time points | Visual Analogic Scale | 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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in kinesiophobia at different time points | Tampa Scale of Kinesiophobia | 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, pain neurophysiology education, motor control