NCT03910829

Brief Summary

This study evaluates the influence of motor imagery or action observation training on joint position error in patients with chronic neck pain. This variable is a measure of proprioception and cervical motor control. A group of patients will receive an action observation training of neck movements, another will receive a protocol of motor imagery of the same movements and the last group will be a placebo group, through the viewing of a documentary video.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 2, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 10, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

April 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

April 2, 2019

Last Update Submit

April 9, 2019

Conditions

Keywords

Motor ImageryAction observation

Outcome Measures

Primary Outcomes (1)

  • Joint Position Error (JPE)

    JPE will be assessed with Motion Guidance Clinic Kit. This device consisted of adjustable straps and a fastening support for a laser beam. Patients were asked to sit in a comfortable position at a 90-cm distance from the bullseye with the device correctly placed. With eyes closed, they were asked to point to the neutral position of the head and memorize. This point was recorded as a reference for each patient. The patient subsequently performed a maximal movement of cervical flexion and then attempted to find the initial reference position with a maximum of precision without speed instruction. The point on which the light beam stopped indicated the global error measured in centimeters (cm) in relation to the center of the target recorded previously. The same protocol was used for the extension, right and left rotation movements. Ten trials were performed with head repositioning after each movement, and the mean measure was recorded.

    Change from baseline and immediately post-intervention

Secondary Outcomes (6)

  • Visual and Kinesthetic Motor Imagery Ability

    Immediately before the intervention

  • Mental Chronometry

    Immediately before the intervention

  • The degree of physical activity

    Immediately before the intervention

  • Laterality task

    Immediately before the intervention

  • Pain catastrophizing

    Immediately before the intervention

  • +1 more secondary outcomes

Study Arms (3)

Action Observation

EXPERIMENTAL

This group receives an action observation training through the visualization of a video of cervical movements.

Behavioral: Action Observation

Motor Imagery

EXPERIMENTAL

This group receives an motor imagery through the imagery process of cervical movements.

Behavioral: Motor Imagery

Placebo Group

PLACEBO COMPARATOR

This group receives a placebo action observation training through the visualization of a video of a documentary video

Behavioral: Placebo Action Observation

Interventions

Action observation training

Action Observation
Motor ImageryBEHAVIORAL

Motor imagery protocol

Motor Imagery

Placebo Action Observation

Placebo Group

Eligibility Criteria

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

You may qualify if:

  • Men and women aged between 18 and 65 years
  • Medical diagnosis of NSCNP with more than 6 months of evolution of neck pain

You may not qualify if:

  • Patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries o a history of arthrodesis
  • Systemic diseases
  • Vision, hearing or vestibular problems
  • Severe trauma or a traffic accident that had an impact on the cervical area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ferran Cuenca-Martínez, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 10, 2019

Study Start

April 15, 2019

Primary Completion

June 30, 2019

Study Completion

July 31, 2019

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations