The Effect of Auditory and Motor Cognitive Distractions on the Neural Provocation Test in Subjects With Neck Pain

• ClinicalTrials.gov Identifier: NCT04545645
• Recruitment Status: Completed
• First Posted: September 11, 2020
• Last Update Posted: September 11, 2020
• Sponsor: Universidad Autonoma de Madrid
• Collaborator: Centro Universitario La Salle
• Information provided by (Responsible Party): Roy La Touche Arbizu, Universidad Autonoma de Madrid

Study Description

Brief Summary:

The main objective of this research is to evaluate the influence of different distraction stimuli on neural mechano-sensitivity tests.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Behavioral: median nerve mobilization; Behavioral: Neural stress provocation with cognitive auditory distraction; Behavioral: Providing neural stress with a motor distraction; Behavioral: Neural stress provocation with auditory and motor cognitive distraction.	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: The Effect of Auditory and Motor Cognitive Distractions on the Neural Provocation Test in Subjects With Neck Pain: A Randomized Controlled Trial
• Actual Study Start Date: September 1, 2019
• Actual Primary Completion Date: September 1, 2020
• Actual Study Completion Date: September 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Neural Stress Provoked by the Median Nerve	Behavioral: median nerve mobilization; 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.
Experimental: Neural stress provocation with cognitive auditory distraction	Behavioral: Neural stress provocation with cognitive auditory distraction; 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.
Experimental: Providing neural stress with a motor distraction	Behavioral: Providing neural stress with a motor distraction; 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.
Experimental: Neural stress provocation with both distractions	Behavioral: Neural stress provocation with auditory and motor cognitive distraction.; 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.

Outcome Measures

Primary Outcome Measures :

1. Mechanosensitivity based on range of motion [ Time Frame: Change in pressure pain threshold immediately at the end of the intervention ]
   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.
2. Pain intensity [ Time Frame: Change in pain intensity immediately at the end of the intervention ]
   It is the subjective feeling of self-reported pain ranging from 0-100 points.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Spain

CSEU La Salle

Madrid, Spain, 28023

Sponsors and Collaborators

Universidad Autonoma de Madrid

Centro Universitario La Salle

More Information

• Responsible Party: Roy La Touche Arbizu, Principal Investigator, Universidad Autonoma de Madrid
• ClinicalTrials.gov Identifier: NCT04545645
• Other Study ID Numbers: uammadrid30
• First Posted: September 11, 2020
• Last Update Posted: September 11, 2020
• Last Verified: September 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Neck Pain; Pain; Neurologic Manifestations