NCT03232879

Brief Summary

The main objective of this study was to compare the activation of the Sympathetic Nervous System in a program that combined Motor Imagery with Action Observation, in contrast to an isolated Motor Imagery program on the one hand in asymptomatic subjects and in the other hand in patients with chronic low back pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

July 24, 2017

Last Update Submit

February 28, 2018

Conditions

Keywords

Motor ImageryAction ObservationHeart RateRespiration RateElectrodermal Activity

Outcome Measures

Primary Outcomes (3)

  • Electrodermal Activity

    Electrodermal Activity will be measured through the use of two electrodes that recorded changes in conductance through the skin located at the back of the dominant hand

    Change in electrodermal activity after 5 minutes post-intervention

  • Respiration Rate

    Respiration Rate will be measured through a pressure transducer located in the centre of the chest, where it was fixed by a strap

    Change in respiration rate after 5 minutes post-intervention

  • Heart Rate

    Heart Rate will be measured by three electrodes located in the left area of the chest. One of the electrodes was placed in the middle zone while a second electrode was positioned on the lateral side, and a third one on the lower left side, below the first electrode.

    Change in heart rate after 5 minutes post-intervention

Secondary Outcomes (3)

  • Visual and Kinesthetic Motor Imagery Ability

    Pre-intervention

  • Mental Chronometry

    Pre-intervention

  • The degree of physical activity

    Pre-intervention

Study Arms (3)

Experimental 1

EXPERIMENTAL

Motor Imagery

Behavioral: Motor Imagery

Experimental 2

EXPERIMENTAL

Action Observation

Behavioral: Action Observation

Control Group

NO INTERVENTION

No intervention

Interventions

Motor ImageryBEHAVIORAL

Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).

Experimental 1

Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R). Before the subjects performed the mental MI practice, they were presented with a 30 seconds video that displayed the task that they ought to imagine later. A video was played prior to the first practice of imagination and after the second mental practice, a second video was shown.

Experimental 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 60
  • Healthy and with no pain subjects
  • Low back pain for at least the prior 3 months
  • Low back pain of nonspecific nature
  • Age between 18 and 60
  • Low back pain for at least 10 days per month
  • Intensity of pain of between 3 and 10 on the Visual Analogue Scale

You may not qualify if:

  • Any cognitive impairment that hindered viewing of audiovisual material.
  • Difficulty understanding or communicating.
  • Presence of systemic pathology, Central Nervous System or rheumatic disease.
  • Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
  • Collaboration of pregnant women.
  • Underage subjects
  • Subjects with pain at the time of the study.
  • Any cognitive impairment that hindered viewing of audiovisual material.
  • Difficulty understanding or communicating.
  • Presence of systemic pathology, Central Nervous System or rheumatic disease.
  • Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
  • Collaboration of pregnant women.
  • Underage subjects
  • Having undergone back surgery
  • Specific spinal pathology
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 28, 2017

Study Start

January 30, 2017

Primary Completion

April 10, 2017

Study Completion

June 30, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations