Back to resultsThe Effect of Auditory and Motor Cognitive Distractions on the Neural Provocation Test in Subjects With Neck Pain
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
median nerve mobilization
Neural stress provocation with cognitive auditory distraction
Providing neural stress with a motor distraction
Neural stress provocation with auditory and motor cognitive distraction.
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- 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
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.
Sites / Locations
- CSEU La Salle
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Neural Stress Provoked by the Median Nerve
Neural stress provocation with cognitive auditory distraction
Providing neural stress with a motor distraction
Neural stress provocation with both distractions
Arm Description
Outcomes
Primary Outcome Measures
Mechanosensitivity based on range of motion
The inclinometer, an instrument characterized by the constant use of gravity as a reference point to evaluate mobility, is used to evaluate the range of nerve movement.
Pain intensity
It is the subjective feeling of self-reported pain ranging from 0-100 points.
Secondary Outcome Measures
Full Information
NCT ID
NCT04545645
First Posted
September 4, 2020
Last Updated
September 10, 2020
Sponsor
Universidad Autonoma de Madrid
Collaborators
Centro Universitario La Salle
1. Study Identification
Unique Protocol Identification Number
NCT04545645
Brief Title
The Effect of Auditory and Motor Cognitive Distractions on the Neural Provocation Test in Subjects With Neck Pain
Official Title
The Effect of Auditory and Motor Cognitive Distractions on the Neural Provocation Test in Subjects With Neck Pain: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Madrid
Collaborators
Centro Universitario La Salle
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main objective of this research is to evaluate the influence of different distraction stimuli on neural mechano-sensitivity tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neural Stress Provoked by the Median Nerve
Arm Type
Active Comparator
Arm Title
Neural stress provocation with cognitive auditory distraction
Arm Type
Experimental
Arm Title
Providing neural stress with a motor distraction
Arm Type
Experimental
Arm Title
Neural stress provocation with both distractions
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
median nerve mobilization
Intervention Description
The patient is placed in a supine position and his cervical spine with 25º of lateral flexion on the opposite side of the member in which we perform the test. First a passive scapular depression is performed, 90º of shoulder abduction combining external shoulder rotation. Next, a supination of the forearm is performed with wrist extension and finger extension. Finally, the elbow is extended to the limit of resistance or when the investigator observes the elevation of the shoulder girdle.
Intervention Type
Behavioral
Intervention Name(s)
Neural stress provocation with cognitive auditory distraction
Intervention Description
Neural provocation of the median nerve is performed but an auditory distraction is added with a metronome with a constant time of 50 beats per minute.
Intervention Type
Behavioral
Intervention Name(s)
Providing neural stress with a motor distraction
Intervention Description
The neural provocation of the median nerve is performed and we add a motor distraction that consists of the patient intermittently squeezing a ball with the opposite hand.
Intervention Type
Behavioral
Intervention Name(s)
Neural stress provocation with auditory and motor cognitive distraction.
Intervention Description
The neural provocation of the median nerve is performed, we add auditory distraction with the metronome with a constant time of 50 BPM and a motor distraction consisting of squeezing a ball to the rhythm that sounds the metronome.
Primary Outcome Measure Information:
Title
Mechanosensitivity based on range of motion
Description
The inclinometer, an instrument characterized by the constant use of gravity as a reference point to evaluate mobility, is used to evaluate the range of nerve movement.
Time Frame
Change in pressure pain threshold immediately at the end of the intervention
Title
Pain intensity
Description
It is the subjective feeling of self-reported pain ranging from 0-100 points.
Time Frame
Change in pain intensity immediately at the end of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Facility Information:
Facility Name
CSEU La Salle
City
Madrid
ZIP/Postal Code
28023
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
The Effect of Auditory and Motor Cognitive Distractions on the Neural Provocation Test in Subjects With Neck Pain
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