- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03910829
Effects of Motor Imagery and Action Observation Training on Neck Reposition Sense in Patients With Chronic Neck Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Motor imagery is defined as a dynamic mental process of an action, without its real motor execution. Action observation training consists of watching an action performed by someone else. Both motor imagery and action observation have been shown to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a manner that resembles how the action is performed in reality.
Both motor imagery and action observation are interventions that can generate adaptive neuroplastic changes on a cortical level, leading to a decrease in chronic pain. These rehabilitation techniques are used in pain treatment and impaired movement injuries that could be due to a nervous system alteration.
The effectiveness of motor imagery is controversial; several studies have presented unfavorable outcomes from this technique. Some variables, such as the duration of the sessions, the time employed the type of motor task or the number of sessions can influence the outcomes of these studies. Thus, it is necessary to clarify the controversial aspects of motor imagery, which lead us to perform this study.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Madrid, Spain, 28023
- CSEU La Salle
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women aged between 18 and 65 years
- Medical diagnosis of NSCNP with more than 6 months of evolution of neck pain
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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EXPERIMENTAL: Action Observation
This group receives an action observation training through the visualization of a video of cervical movements.
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Action observation training
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EXPERIMENTAL: Motor Imagery
This group receives an motor imagery through the imagery process of cervical movements.
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Motor imagery protocol
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PLACEBO_COMPARATOR: Placebo Group
This group receives a placebo action observation training through the visualization of a video of a documentary video
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Placebo Action Observation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint Position Error (JPE)
Time Frame: Change from baseline and immediately post-intervention
|
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.
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Change from baseline and immediately post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual and Kinesthetic Motor Imagery Ability
Time Frame: Immediately before the intervention
|
Visual and Kinesthetic Motor Imagery Ability will be measured with Movement Imagery Questionnaire-Revised (MIQ-R).
MIQ-R has four movements repeated in two subscales, a visual and a kinesthetic one.
Additionally, a score between 1 and 7 is assigned, with 1 representing difficulty in picturing the motor image or difficulty in feeling the movement previously made, and 7 representing the maximum ease.
The internal consistencies of the MIQ-R have been consistently adequate with Cronbach's α coefficients ranging above 0.84 for the total scale, 0.80 for de visual subscale and 0.84 for the kinesthetic subscale (Campos & González, 2010).
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Immediately before the intervention
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Kinesiophobia
Time Frame: Immediately before the intervention
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Fear of movement or kinesiophobia will be quantified with the Spanish version of the Kinesiophobia Tampa Scale (TSK-11).
This instrument demonstrates reliability and validity in patients with chronic pain, being shorter than the original scale.
The total score ranges from 11 to 44 points, with the highest scores indicating greater fear of a new injury due to movement
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Immediately before the intervention
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Mental Chronometry
Time Frame: Immediately before the intervention
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Mental chronometry evaluation was also used to measure the subject's motor imagery
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Immediately before the intervention
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The degree of physical activity
Time Frame: Immediately before the intervention
|
The degree of physical activity was objectified through the IPAQ questionnaire, which allows the subjects to be divided into three groups according to their level of activity, which can be high, moderate, and low or inactive (Roman-Viñas et al., 2010).
This questionnaire has shown an acceptable validity to measure total physical activity.
Therefore, the psychometric properties of the questionnaire were accepted for use in studies that required the measurement of physical activity.
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Immediately before the intervention
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Laterality task
Time Frame: Immediately before the intervention
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With the task of recognition of the neck's laterality, two aspects will be evaluated: first, the precision (percentage of correct answers) of the discrimination of the laterality which is the capacity to recognize if a part of the body belongs to the right or left and second, the response time that the participants use in the task of discrimination or cognitive judgment.
The app designed and developed by the NOI group will be used.
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Immediately before the intervention
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Pain catastrophizing
Time Frame: Immediately before the intervention
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The Spanish version of the pain catastrophizing scale (PCS) assesses the degree of pain catastrophizing.
The PCS has 13 items and a 3-factor structure of rumination, magnification, and helplessness.
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Immediately before the intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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