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

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ClinicalTrials.gov Identifier: NCT03409562
Recruitment Status : Recruiting
First Posted : January 24, 2018
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
Hospital Universitario Fundación Alcorcón
Hospital Clínico San Carlos
Information provided by (Responsible Party):
Gustavo Plaza Manzano, Universidad Complutense de Madrid

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: motor control training Behavioral: pain neurophysiology education Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Patients With Unspecific Low Back Pain
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03409562


Contacts
Contact: Gustavo Plaza-Manzano, Ph.D 609578380 gusplaza@ucm.es

Locations
Spain
Hospital Universitario Fundación Alcorcón Recruiting
Alcorcón, Madrid, Spain, 28922
Contact: Alicia Urraca-Gesto         
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Miriam Robledo-García         
Sponsors and Collaborators
Universidad Complutense de Madrid
Hospital Universitario Fundación Alcorcón
Hospital Clínico San Carlos
Investigators
Study Director: Gustavo Plaza-Manzano, Ph.D Universidad Complutense de Madrid

Responsible Party: Gustavo Plaza Manzano, Director, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT03409562     History of Changes
Other Study ID Numbers: CI 17/108
18/068-E ( Other Identifier: CEIC Hospital Clínico San Carlos )
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gustavo Plaza Manzano, Universidad Complutense de Madrid:
low back pain
pain neurophysiology education
motor control

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms