NCT04545645

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 4, 2020

Last Update Submit

September 10, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Neural Stress Provoked by the Median Nerve

ACTIVE COMPARATOR
Behavioral: median nerve mobilization

Neural stress provocation with cognitive auditory distraction

EXPERIMENTAL
Behavioral: Neural stress provocation with cognitive auditory distraction

Providing neural stress with a motor distraction

EXPERIMENTAL
Behavioral: Providing neural stress with a motor distraction

Neural stress provocation with both distractions

EXPERIMENTAL
Behavioral: Neural stress provocation with auditory and motor cognitive distraction.

Interventions

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.

Neural Stress Provoked by the Median Nerve

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.

Neural stress provocation with cognitive auditory 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.

Providing neural stress with a motor 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.

Neural stress provocation with both distractions

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 11, 2020

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

September 11, 2020

Record last verified: 2020-09

Locations