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Clinical Trials/NCT03409562
NCT03409562
Completed
Not Applicable

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

Universidad Complutense de Madrid2 sites in 1 country62 target enrollmentFebruary 14, 2018
ConditionsLow Back Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Universidad Complutense de Madrid
Enrollment
62
Locations
2
Primary Endpoint
Change in pain at different time points
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 14, 2018
End Date
June 9, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gustavo Plaza Manzano

Director

Universidad Complutense de Madrid

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change in quality of life at different time points(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 kinesiophobia at different time points(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(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)

Study Sites (2)

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