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

The Effect of Auditory and Motor Cognitive Distractions on the Neural Provocation Test in Subjects With Neck Pain: A Randomized Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28023
    • CSEU La Salle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change in pressure pain threshold immediately at the end of the intervention
Pain intensity	It is the subjective feeling of self-reported pain ranging from 0-100 points.	Change in pain intensity immediately at the end of the intervention

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid
• Collaborators: Centro Universitario La Salle

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2019
• Primary Completion (ACTUAL): September 1, 2020
• Study Completion (ACTUAL): September 1, 2020

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (ACTUAL): September 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Neck Pain
• Other Study ID Numbers: uammadrid30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No