- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03861312
Laterality Discrimination in Patients With Non-specific Chronic Neck Pain
Effects of Laterality Discrimination in Patients With Non-specific Chronic Neck Pain. Randomized Blind Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The most consistent data come from the investigation of the primary motor cortex, in which the cortical representations of the altered body part are affected when there is chronic pain. Occasionally, the primary motor cortex is smaller on the affected side than on the contralateral side.
Recognition of the body schema is altered in the presence of painful disorders. The most common way of assessing the body schema is by motor imagery through the laterality discrimination of the left and right.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The inclusion criteria were as follows: a) men and women aged between 18- and 65-years b) medical diagnosis of Non-Specific Chronic Neck Pain with more than 6 months of evolution of neck pain.
Exclusion Criteria:
- Exclusion criteria included the following: a) patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries or history of arthrodesis, b) systemic diseases, c) vision, hearing or vestibular problems, d) Severe trauma or traffic accident which has had an impact on the cervical area.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neck Laterality
It was done with 20 images of necks and 4 seconds for each image in the Vanilla program of the tablet application.
|
Patients who belonged to the neck group performed the recognition of laterality with certain parameters.
The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test.
It was done with 20 images and 4 seconds for each image in the "Vanilla" program
|
|
Experimental: Foot Laterality
It was done with 20 images of feet and 4 seconds for each image in the Vanilla program of the tablet application.
|
Patients who belonged to the foot group performed the recognition of laterality with certain parameters.
The execution of the recognition began with a test to familiarize themselves with the program at the "Basic" level and then followed the laterality test.
It was done with 20 images and 4 seconds for each image in the "Vanilla" program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Response time
Time Frame: Immediately post-intervention
|
Changes in the time response.
Time response is defined as the time between the image appearance and the subject response.
|
Immediately post-intervention
|
|
Accuracy
Time Frame: Immediately post-intervention
|
Changes in the accuracy at the end of the intervention.
Accuracy must be taken as the precision of the response when a subject say wether the image is right or left.
It is measured by percentage of success.
|
Immediately post-intervention
|
|
Joint Position Error
Time Frame: Immediately post-intervention
|
Changes in the joint position error at the end of the intervention.
It is measured on centimeters.
|
Immediately post-intervention
|
|
Cervical Active Range of Motion
Time Frame: immediately post-intervention
|
Changes the cervical active range of motion at the end of the intervention.
It is measured on centimeters.
|
immediately post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: David Marcos Lorenzo, Msc, d.marcosl20@gmail.com
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- CSEULS-PI-155/2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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