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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
motor control training
pain neurophysiology education
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, pain neurophysiology education, motor control

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Fundación Alcorcón
  • Hospital Clínico San Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain Neurophysiology Education and motor control training

motor control training alone

Arm Description

This group will undergo two pain neurophysiology education sessions prior to motor control training.

This group will only perform motor control training.

Outcomes

Primary Outcome Measures

Change in pain at different time points
Visual Analogic Scale
Change in disability at different time points
Oswestry Disability Index

Secondary Outcome Measures

Change in kinesiophobia at different time points
Tampa Scale of Kinesiophobia
Change in Global Perceived Effect at different time points
Global Perceived Effect Scale
Change in quality of life at different time points
SF-12 questionnaire

Full Information

First Posted
January 10, 2018
Last Updated
June 29, 2022
Sponsor
Universidad Complutense de Madrid
Collaborators
Hospital Universitario Fundación Alcorcón, FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS
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1. Study Identification

Unique Protocol Identification Number
NCT03409562
Brief Title
Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Unspecific Low Back Pain
Official Title
Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Patients With Unspecific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
May 3, 2021 (Actual)
Study Completion Date
June 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
Hospital Universitario Fundación Alcorcón, FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, pain neurophysiology education, motor control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Neurophysiology Education and motor control training
Arm Type
Experimental
Arm Description
This group will undergo two pain neurophysiology education sessions prior to motor control training.
Arm Title
motor control training alone
Arm Type
Active Comparator
Arm Description
This group will only perform motor control training.
Intervention Type
Behavioral
Intervention Name(s)
motor control training
Intervention Description
Exercises to strengthen the lumbar musculature and control the posture.
Intervention Type
Behavioral
Intervention Name(s)
pain neurophysiology education
Other Intervention Name(s)
pain neuroscience education
Intervention Description
Educational sessions to improve patient's neurophysiology of pain knowledge.
Primary Outcome Measure Information:
Title
Change in pain at different time points
Description
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
Title
Change in disability at different time points
Description
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 Outcome Measure Information:
Title
Change in kinesiophobia at different time points
Description
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
Title
Change in Global Perceived Effect at different time points
Description
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
Title
Change in quality of life at different time points
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Plaza-Manzano, Ph.D
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario Fundación Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

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

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