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Teleassessment in Neck Pain (Teleneck)

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ClinicalTrials.gov Identifier: NCT04646720
Recruitment Status : Not yet recruiting
First Posted : November 30, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Study Description
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Brief Summary:
New technologies have improved the aproach of patients with different pathologies. Neck pain is a prevalent pathology in physical therapy clinics. Evaluating patients with an electronical device could decrease the services saturation and the proffesionals overload.

Condition or disease
Neck Pain Assessment, Self Kinesiophobia

Study Design
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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Teleassessment in Neck Pain Patients: an Observational Study
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Neck pain patients
Patients with neck pain evaluated with new technologies and face-to-face


Outcome Measures
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Primary Outcome Measures :
  1. Changes in range of movement [ Time Frame: Baseline ]
    Changes in range of movement were measured with goniometry and expressed in degrees.

  2. Changes in trigger points [ Time Frame: Baseline ]
    Changes in trigger points were measured following the Travels and Simons protocol in the trapezius, suboccipitalis, scalenes and sternocleidomastoid muscles. The number od trigger points found was registered.

  3. Changes in neck endurance (anterior) [ Time Frame: Baseline ]
    Changes in neck endurance were measured using an endurance test for the anterior neck muscles. The time performing the test was registered.

  4. Changes in neck endurance (posterior) [ Time Frame: Baseline ]
    Changes in neck endurance were measured using an endurance test for the posterior neck muscles. The time performing the test was registered.

  5. Changes in quality of life [ Time Frame: Baseline ]
    Changes in quality of life were measured using the Euroqol 5dimensions which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. It also includes a visual analogue scale to report the health status from 0 to 100.

  6. Changes in quality of life (Visual Analogue Scale) [ Time Frame: Baseline ]
    Changes in quality of life were measured using the Euroqol 5dimensions which comprises a visual analogue scale to report the health status from 0 to 100.


Secondary Outcome Measures :
  1. Changes in kinesiophobia [ Time Frame: Baseline ]
    Changes in kinesiophobia were measured using the Tampa Scale for Kinesiophobia (TSK) which is one of the most frequently employed measures for assessing pain-related fear in pain patients.

  2. Changes in functionality [ Time Frame: Baseline ]
    Changes in functionality were measured using the World Health Organization Disability Assessment Schedule, WHODAS-2, which provides a global measure of disability and 7 domain-specific scores.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic neck pain
Criteria

Inclusion Criteria:

  • Presence of neck pain
  • Between 18 and 65 years
  • Accepted to sign the informed consent

Exclusion Criteria:

  • Cognitive impairment.
  • Traumatic accidents.
  • Other orthopedic or neurologic pathology.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Marie Carmen Valenza, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04646720    
Other Study ID Numbers: DF0092UG
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neck Pain
Pain
Neurologic Manifestations