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Completed

NCT Number: NCT03409562

Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for 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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

motor control training

Behavioral

Exercises to strengthen the lumbar musculature and control the posture.

Pain Neurophysiology Education

Behavioral

Educational sessions to improve patient's neurophysiology of pain knowledge.

Other names: pain neuroscience education

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

    Tampa Scale of Kinesiophobia

  2. 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

    Global Perceived Effect Scale

  3. 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

    SF-12 questionnaire

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
  • Hospital Universitario Fundación Alcorcón

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2018
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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