NCT03409562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

February 14, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

3.2 years

First QC Date

January 10, 2018

Last Update Submit

June 29, 2022

Conditions

Low Back Pain

Keywords

low back painpain neurophysiology educationmotor control

Outcome Measures

Primary Outcomes (2)

  • Change in pain at different time points

    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

    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 Outcomes (3)

  • 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

  • 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

Study Arms (2)

Pain Neurophysiology Education and motor control training

EXPERIMENTAL

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

Behavioral: motor control trainingBehavioral: pain neurophysiology education

motor control training alone

ACTIVE COMPARATOR

This group will only perform motor control training.

Behavioral: motor control training

Interventions

motor control trainingBEHAVIORAL

Exercises to strengthen the lumbar musculature and control the posture.

Pain Neurophysiology Education and motor control trainingmotor control training alone
pain neurophysiology educationBEHAVIORAL

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

Also known as: pain neuroscience education
Pain Neurophysiology Education and motor control training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gustavo Plaza-Manzano, Ph.D

    Universidad Complutense de Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 24, 2018

Study Start

February 14, 2018

Primary Completion

May 3, 2021

Study Completion

June 9, 2021

Last Updated

July 5, 2022

Record last verified: 2022-06

Locations

ES(2)