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

NCT ID: NCT03409562

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-14

Study Completion Date

2021-06-09

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Pain Neurophysiology Education and motor control training

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

Group Type EXPERIMENTAL

motor control training

Intervention Type BEHAVIORAL

Exercises to strengthen the lumbar musculature and control the posture.

pain neurophysiology education

Intervention Type BEHAVIORAL

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

motor control training alone

This group will only perform motor control training.

Group Type ACTIVE_COMPARATOR

motor control training

Intervention Type BEHAVIORAL

Exercises to strengthen the lumbar musculature and control the posture.

Interventions

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motor control training

Exercises to strengthen the lumbar musculature and control the posture.

Intervention Type BEHAVIORAL

pain neurophysiology education

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

Intervention Type BEHAVIORAL

Other Intervention Names

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pain neuroscience education

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Fundación Alcorcón

OTHER

Sponsor Role collaborator

FUNDACION PARA LA INVESTIGACION HOSPITAL CLINICO SAN CARLOS

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Gustavo Plaza Manzano

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gustavo Plaza-Manzano, Ph.D

Role: STUDY_DIRECTOR

Universidad Complutense de Madrid

Locations

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Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Site Status

Hospital Clínico San Carlos

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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18/068-E

Identifier Type: OTHER

Identifier Source: secondary_id

CI 17/108

Identifier Type: -

Identifier Source: org_study_id

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