Pain, ChronicNCT03905577
Effects of Motor Imagery and Action Observation Training on Pain Perception in Patients With Chronic Neck Pain
A study testing Action Observation and Motor imagery in people with Pain, Chronic, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
This study evaluates the influence of motor imagery or action observation training on pain perception in patients with chronic neck pain. Perception of pain will be measured by the pain pressure threshold. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- Action Observation and Motor imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2019to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 65 years
- Medical diagnosis of non specific chronic neck pain with more than 6 months of evolution of neck pain
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the influence of motor imagery or action observation training on pain perception in patients with chronic neck pain. Perception of pain will be measured by the pain pressure threshold.
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.
Read the 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.
- Conditions
- Pain, Chronic
- Being tested
- Action Observation, Motor imagery, Placebo Action observation
- Keywords
- Motor Imagery, Action observation, Pain perception
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action ObservationBehavioural
Action Observation training
Motor imageryBehavioural
Motor imagery protocol
Placebo Action observationBehavioural
Placebo Action Observation
| Study group | Role | What they receive |
|---|---|---|
| Action Observation | Experimental | This group receives an action observation training through the visualization of a video of cervical movements. Receives: Behavioral: Action Observation |
| Motor Imagery | Experimental | This group receives an motor imagery through the imagery process of cervical movements. Receives: 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 Receives: Behavioral: Placebo Action observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain pressure threshold
Pressure Pain Threshold (PPT) is one of these tests and it is defined as the minimum force applied which induces pain. The measurement shall be carried out by using an algometer (pressure device that induces mechanical stimuli) is to standardize the amount of pressure applied in the neck region. The reliability of pressure pain thresholds according to raters or measurement frequencies is relatively high
Measured: Change from baseline and immediately post-intervention.
Secondary outcomes (6)
Visual and Kinesthetic Motor Imagery Ability
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).
Measured: Immediately before the intervention
Mental Chronometry
Mental chronometry evaluation was also used to measure the subject's motor imagery
Measured: Immediately before the intervention
The degree of physical activity
The degree of physical activity was objectified through the The International Physical Activity Questionnaire 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
Measured: Immediately before the intervention
Laterality task
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.
Measured: Immediately before the intervention
Pain catastrophizing
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.
Measured: Immediately before the intervention
Kinesiophobia
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
Measured: Immediately before the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start15 Apr 2019
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy La Touche Arbizu, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905577
- Sponsor's protocol ID
- uamadrid7
- Status last verified
- Jul 2019
- First submitted
- 2 Apr 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery and Action Observation Training on Pain Perception in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT03905577
- Acronym / sponsor ID
- uamadrid7
- Conditions
- Pain, Chronic
- Keywords
- Motor Imagery, Action observation, Pain perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the influence of motor imagery or action observation training on pain perception in patients with chronic neck pain. Perception of pain will be measured by the pain pressure threshold.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Action Observation | Experimental | Behavioral: Action ObservationThis group receives an action observation training through the visualization of a video of cervical movements. |
| Motor Imagery | Experimental | Behavioral: Motor imageryThis group receives an motor imagery through the imagery process of cervical movements. |
| Placebo Group | Placebo comparator | Behavioral: Placebo Action observationThis group receives a placebo action observation training through the visualization of a video of a documentary video |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged between 18 and 65 years
- Medical diagnosis of non specific chronic neck pain with more than 6 months of evolution of neck pain
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action ObservationAction Observation training | Behavioural | Action Observation |
| Motor imageryMotor imagery protocol | Behavioural | Motor Imagery |
| Placebo Action observationPlacebo Action Observation | Behavioural | Placebo Group |
Primary outcome
Pain pressure threshold
Time frame: Change from baseline and immediately post-intervention.
Pressure Pain Threshold (PPT) is one of these tests and it is defined as the minimum force applied which induces pain. The measurement shall be carried out by using an algometer (pressure device that induces mechanical stimuli) is to standardize the amount of pressure applied in the neck region. The reliability of pressure pain thresholds according to raters or measurement frequencies is relatively high
6 secondary outcomes
Visual and Kinesthetic Motor Imagery Ability
Time frame: Immediately before the intervention
Mental Chronometry
Time frame: Immediately before the intervention
The degree of physical activity
Time frame: Immediately before the intervention
Laterality task
Time frame: Immediately before the intervention
Pain catastrophizing
Time frame: Immediately before the intervention
Kinesiophobia
Time frame: Immediately before the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action Observation and Motor imagery in people with Pain, Chronic, run by Universidad Autonoma de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain pressure threshold (time frame: Change from baseline and immediately post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.