- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03547752
Inmediate Effect of the Visualization of Action
June 4, 2018 updated by: Raúl Ferrer-Peña, Universidad Autonoma de Madrid
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28053
- CS Entrevías
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Nos-Specific Chronic Neck Pain lasting more than 3 months
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Effective movement group
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.
|
Observation of a video of neck movement and imagination of the same observed movement, feeling the realization of the movement but not developing it.
|
|
Experimental: Ineffective movement group
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.
|
Observation of a video of neck movement and imagination of the same observed movement, feeling the realization of the movement but not developing it.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
at the beginning and after the intervention, until the end of the study (24 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Pain Disability
Time Frame: at the beginning and end of the intervention, until the end of the study (24 hours)
|
Neck Disability Index
|
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)
|
Visual Ananlogue Scale: 10cm line, were the left limit means "no pain" and the right limit means "worst imaginable pain"
|
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)
|
Pain Catastrophizing Scale
|
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)
|
EuroQoL-5D-5L
|
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)
|
Hospital Anxiety and Depression Scale (HADs)
|
at the beginning and end of the intervention, until the end of the study (24 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Eaves 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.
- 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.
- Munoz-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.
- Niddam 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.
- Mao 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
April 30, 2018
Study Completion (Actual)
April 30, 2018
Study Registration Dates
First Submitted
May 1, 2018
First Submitted That Met QC Criteria
June 4, 2018
First Posted (Actual)
June 6, 2018
Study Record Updates
Last Update Posted (Actual)
June 6, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OA plus MI in neck pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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