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

June 29, 2022 updated by: Gustavo Plaza Manzano, Universidad Complutense de Madrid

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pain Neurophysiology Education and motor control training
This group will undergo two pain neurophysiology education sessions prior to motor control training.
Behavioral: motor control training
Exercises to strengthen the lumbar musculature and control the posture.
Behavioral: pain neurophysiology education
Educational sessions to improve patient's neurophysiology of pain knowledge.
Other Names:
  • pain neuroscience education
ACTIVE_COMPARATOR: motor control training alone
This group will only perform motor control training.
Behavioral: motor control training
Exercises to strengthen the lumbar musculature and control the posture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 14, 2018

Primary Completion (ACTUAL)

May 3, 2021

Study Completion (ACTUAL)

June 9, 2021

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (ACTUAL)

January 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CI 17/108
  • 18/068-E (OTHER: CEIC Hospital Clínico San Carlos)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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