Clinical trial NCT03409562: Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Unspecific Low Back Pain
Official title: Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Patients With Unspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
pain neurophysiology education
motor control
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Fundación Alcorcón
name: FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
First posted: 2018-01-24
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in pain at different time points
timeFrame: 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
measure: Change in disability at different time points
timeFrame: 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:
measure: Change in kinesiophobia at different time points
timeFrame: Assessed before the intervention, at the end of the 4-week intervention and 3 and 6 months after the end of the intervention
measure: Change in Global Perceived Effect at different time points
timeFrame: 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
measure: Change in quality of life at different time points
timeFrame: 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
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: Universidad Complutense de Madrid
name: Gustavo Plaza-Manzano, Ph.D
role: STUDY_DIRECTOR
References: