Neck PainNCT03547752
Inmediate Effect of the Visualization of Action
A study testing observed action and motor imaginery in people with Neck Pain and Chronic Pain, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The observation of actions and motor imagery has demonstrated the activation of certain mechanisms similar to those that occur during active movement, which could induce immediate changes in the amplitudes of movement and sensorimotor variables in observed and imagined movements. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neck Pain, Chronic Pain, Musculoskeletal Pain
- What is being tested?
- observed action and motor imaginery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2017to 30 Apr 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nos-Specific Chronic Neck Pain lasting more than 3 months
Who cannot join
- Systemic Disease diagnosed (i.e. Lupus, Fibrolyalgia or Rheumatoid Arthritis)
- Background of fractures or surgery in the cervical region
- congenital anomalies known
- infectious processes or diagnosis of active cancer at the time of the study
Trial locations and contacts
1 site in 1 country.
About this study
The observation of actions and motor imagery has demonstrated the activation of certain mechanisms similar to those that occur during active movement, which could induce immediate changes in the amplitudes of movement and sensorimotor variables in observed and imagined movements. The main aim of the study was test the immediate effect of a protocol of observed actions and motor imagery on cervical range of motion and pain intensity in patients with non-specific chronic neck pain (NSCNP). Randomized double-blind clinical trial in patients with DCCI at a primary health care center in the Community of Madrid. A random distribution of study subjects was made into two groups: a) cervical motion videos were presented at full range of motion and b) the videos presented showed a range of motion limited to 40%. In both groups, visualization tasks of actions were alternated with internal kinesthetic motor imagery, in periods of 1min in 2 consecutive series and with a total of 12 minutes of intervention. Cervical range of motion was assessed with a cervical goniometer and pain intensity immediately following the intervention with an Analog Visual Scale.
- Conditions
- Neck Pain, Chronic Pain, Musculoskeletal Pain
- Being tested
- observed action and motor imaginery
- Keywords
- motor imaginery, mental training
- Medical subject headings
- Neck Pain, Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observed action and motor imagineryOther
Observation of a video of neck movement and imagination of the same observed movement, feeling the realization of the movement but not developing it.
| Study group | Role | What they receive |
|---|---|---|
| Effective movement group | Active comparator | Observation of a video of neck movement at 100% range of movement, and imagination of the same observed movement, feeling the realization of the movement but not developing it. Receives: Other: observed action and motor imaginery |
| Ineffective movement group | Experimental | Observation of a video of neck movement at 40% range of movement, and imagination of the same observed movement, feeling the realization of the movement but not developing it. Receives: Other: observed action and motor imaginery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cervical Range of Movement
CROM goniometer
Measured: at the beginning and after the intervention, until the end of the study (24 hours)
Secondary outcomes (5)
Cervical Pain Disability
Neck Disability Index
Measured: at the beginning and end of the intervention, until the end of the study (24 hours)
Pain Intensity
Visual Ananlogue Scale: 10cm line, were the left limit means "no pain" and the right limit means "worst imaginable pain"
Measured: at the beginning and end of the intervention, until the end of the study (24 hours)
Catastrophizism
Pain Catastrophizing Scale
Measured: at the beginning and end of the intervention, until the end of the study (24 hours)
Health Related Quality of Life
EuroQoL-5D-5L
Measured: at the beginning and end of the intervention, until the end of the study (24 hours)
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADs)
Measured: at the beginning and end of the intervention, until the end of the study (24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Mar 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raúl Ferrer-Peña, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547752
- Sponsor's protocol ID
- OA plus MI in neck pain
- Status last verified
- Jun 2018
- First submitted
- 1 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth. 2013 Jul;111(1):13-8. doi: 10.1093/bja/aet123.
PubMed 23794640Munoz-Garcia D, Gil-Martinez A, Lopez-Lopez A, Lopez-de-Uralde-Villanueva I, La Touche R, Fernandez-Carnero J. Chronic Neck Pain and Cervico-Craniofacial Pain Patients Express Similar Levels of Neck Pain-Related Disability, Pain Catastrophizing, and Cervical Range of Motion. Pain Res Treat. 2016;2016:7296032. doi: 10.1155/2016/7296032. Epub 2016 Mar 29.
PubMed 27119020Niddam DM, Lee SH, Su YT, Chan RC. Brain structural changes in patients with chronic myofascial pain. Eur J Pain. 2017 Jan;21(1):148-158. doi: 10.1002/ejp.911. Epub 2016 Jun 28.
PubMed 27352085Mao C, Wei L, Zhang Q, Liao X, Yang X, Zhang M. Differences in brain structure in patients with distinct sites of chronic pain: A voxel-based morphometric analysis. Neural Regen Res. 2013 Nov 15;8(32):2981-90. doi: 10.3969/j.issn.1673-5374.2013.32.001.
PubMed 25206618Eaves DL, Riach M, Holmes PS, Wright DJ. Motor Imagery during Action Observation: A Brief Review of Evidence, Theory and Future Research Opportunities. Front Neurosci. 2016 Nov 21;10:514. doi: 10.3389/fnins.2016.00514. eCollection 2016.
PubMed 27917103
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inmediate Effect of the Visualization of Action
- ClinicalTrials.gov ID
- NCT03547752
- Acronym / sponsor ID
- OA plus MI in neck pain
- Conditions
- Neck Pain, Chronic Pain, Musculoskeletal Pain
- Keywords
- motor imaginery, mental training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 6 Jun 2018 (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.
The observation of actions and motor imagery has demonstrated the activation of certain mechanisms similar to those that occur during active movement, which could induce immediate changes in the amplitudes of movement and sensorimotor variables in observed and imagined movements. The main aim of the study was test the immediate effect of a protocol of observed actions and motor imagery on cervical range of motion and pain intensity in patients with non-specific chronic neck pain (NSCNP). Randomized double-blind clinical trial in patients with DCCI at a primary health care center in the Community of Madrid. A random distribution of study subjects was made into two groups: a) cervical motion videos were presented at full range of motion and b) the videos presented showed a range of motion limited to 40%. In both groups, visualization tasks of actions were alternated with internal kinesthetic motor imagery, in periods of 1min in 2 consecutive series and with a total of 12 minutes of intervention. Cervical range of motion was assessed with a cervical goniometer and pain intensity immediately following the intervention with an Analog Visual Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effective movement group | Active comparator | Other: observed action and motor imagineryObservation of a video of neck movement at 100% range of movement, and imagination of the same observed movement, feeling the realization of the movement but not developing it. |
| Ineffective movement group | Experimental | Other: observed action and motor imagineryObservation of a video of neck movement at 40% range of movement, and imagination of the same observed movement, feeling the realization of the movement but not developing it. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nos-Specific Chronic Neck Pain lasting more than 3 months
Key exclusion criteria (4 listed)
- Systemic Disease diagnosed (i.e. Lupus, Fibrolyalgia or Rheumatoid Arthritis)
- Background of fractures or surgery in the cervical region
- congenital anomalies known
- infectious processes or diagnosis of active cancer at the time of the study
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 |
|---|---|---|
| observed action and motor imagineryObservation of a video of neck movement and imagination of the same observed movement, feeling the realization of the movement but not developing it. | Other | Effective movement group, Ineffective movement group |
Primary outcome
Change in Cervical Range of Movement
Time frame: at the beginning and after the intervention, until the end of the study (24 hours)
CROM goniometer
5 secondary outcomes
Cervical Pain Disability
Time frame: at the beginning and end of the intervention, until the end of the study (24 hours)
Pain Intensity
Time frame: at the beginning and end of the intervention, until the end of the study (24 hours)
Catastrophizism
Time frame: at the beginning and end of the intervention, until the end of the study (24 hours)
Health Related Quality of Life
Time frame: at the beginning and end of the intervention, until the end of the study (24 hours)
Anxiety and Depression
Time frame: at the beginning and end of the intervention, until the end of the study (24 hours)
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 6 Jun 2018.
- Background: PubMed 23794640van Hecke O, Torrance N, Smith BH. Chronic pain epidemiology and its clinical relevance. Br J Anaesth. 2013 Jul;111(1):13-8. doi: 10.1093/bja/aet123.
- Background: PubMed 27119020Munoz-Garcia D, Gil-Martinez A, Lopez-Lopez A, Lopez-de-Uralde-Villanueva I, La Touche R, Fernandez-Carnero J. Chronic Neck Pain and Cervico-Craniofacial Pain Patients Express Similar Levels of Neck Pain-Related Disability, Pain Catastrophizing, and Cervical Range of Motion. Pain Res Treat. 2016;2016:7296032. doi: 10.1155/2016/7296032. Epub 2016 Mar 29.
- Background: PubMed 27352085Niddam DM, Lee SH, Su YT, Chan RC. Brain structural changes in patients with chronic myofascial pain. Eur J Pain. 2017 Jan;21(1):148-158. doi: 10.1002/ejp.911. Epub 2016 Jun 28.
- Background: PubMed 25206618Mao C, Wei L, Zhang Q, Liao X, Yang X, Zhang M. Differences in brain structure in patients with distinct sites of chronic pain: A voxel-based morphometric analysis. Neural Regen Res. 2013 Nov 15;8(32):2981-90. doi: 10.3969/j.issn.1673-5374.2013.32.001.
- Background: PubMed 27917103Eaves DL, Riach M, Holmes PS, Wright DJ. Motor Imagery during Action Observation: A Brief Review of Evidence, Theory and Future Research Opportunities. Front Neurosci. 2016 Nov 21;10:514. doi: 10.3389/fnins.2016.00514. eCollection 2016.
- Individual participant dataSharing planned: Undecided
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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 observed action and motor imaginery in people with Neck Pain and Chronic Pain, 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 1 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 6 Jun 2018. 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. 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?
Change in Cervical Range of Movement (time frame: at the beginning and after the intervention, until the end of the study (24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03547752, which also lists 5 linked publications.
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 6 Jun 2018.