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CompletedNCT03409562Updated Jul 5, 2022

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

An interventional study of motor control training and pain neurophysiology education in Low Back Pain, sponsored by Universidad Complutense de Madrid. Completed at 2 sites in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-05.

Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Low Back Pain

Keywords

  • low back pain
  • pain neurophysiology education
  • motor control
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
62 participants (actual)

Study arms

  • 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 · Behavioral: pain neurophysiology education

  • Active comparator
    motor control training alone

    This group will only perform motor control training.

    Behavioral: motor control training

Interventions

  • Behavioralmotor control training

    Exercises to strengthen the lumbar musculature and control the posture.

  • Behavioralpain neurophysiology education

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

    Also known as: pain neuroscience education

05

What researchers measure

Primary outcomes

  1. Change in pain at different time points

    Visual Analogic Scale

    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

  2. Change in disability at different time points

    Oswestry Disability Index

    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

Secondary outcomes

  1. Change in kinesiophobia at different time points

    Tampa Scale of Kinesiophobia

    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

  2. Change in Global Perceived Effect at different time points

    Global Perceived Effect Scale

    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

  3. Change in quality of life at different time points

    SF-12 questionnaire

    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

06

Study locations

2 sites
  • Hospital Universitario Fundación Alcorcón
    Alcorcón, Madrid 28922, Spain
  • Hospital Clínico San Carlos
    Madrid, 28040, Spain
07

Registry details

Key details

Study ID
NCT03409562
Lead sponsor
Universidad Complutense de Madrid
Collaborators
Hospital Universitario Fundación Alcorcón, FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
Responsible party
Gustavo Plaza Manzano (Director, Universidad Complutense de Madrid) — Principal investigator
First posted
Jan 24, 2018
Start date
Feb 14, 2018
Primary completion
May 3, 2021
Completion
Jun 9, 2021
Last update
Jul 5, 2022

Study contacts

Gustavo Plaza-Manzano, Ph.D
study director · Universidad Complutense de Madrid

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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