Lateral Neck Flexor Endurance and Hyperlaxity

July 21, 2021 updated by: University of Hartford

Lateral Neck Flexor Endurance in Individuals With and Without Systemic Hyperlaxity

The lateral neck flexor endurance test has been proposed to assess for unilateral muscular deficits. It is not known if individuals with hyperlaxity have different muscular endurance than individuals without hyperlaxity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Thirty individuals with systemic hyperlaxity as determined with the Beighton scale will be assessed for lateral neck flexor endurance and compared to age and gender matched controls. Basic demographic information will be collected, and all individuals will report Neck Disability Index (NDI) and Numeric Pain Rating Scales (NPRS) for their neck, as well duration of any neck pain. All participants will then undergo testing of lateral neck flexor muscle endurance, repeated twice on each side. Average hold times will be compared for individuals with hyperlaxity (5 or greater on Beighton scale) and the healthy age and gender matched controls. Analysis will also include covariates of NDI scores, pain scores, and chronicity of symptoms.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Hartford, Connecticut, United States, 06117
        • University of Hartford

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals between the ages of 18-60 with and without systemic hyperlaxity

Description

Inclusion Criteria:

systemic hyperlaxity of 5 or greater on Beighton Index, healthy age/gender matched controls

Exclusion Criteria:

  • neck pain that spreads into the arms;
  • whiplash injury within the last 6 weeks;
  • diagnosed neuropathy or other nervous system disorders;
  • a history of spinal surgery in their neck;
  • fibromyalgia;
  • insulin dependent diabetes;
  • involved in legal activity regarding neck pain

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hyperlaxity
30 individuals with systemic hyperlaxity as defined by a score of 5 or greater on the Beighton Hypermobility Scale
Other: lateral neck flexor endurance test
Individuals will maintain the head in a neutral position off the ground in sidelying for as long as possible.
control
30 healthy, age and gender matched individuals without hyperlaxity
Other: lateral neck flexor endurance test
Individuals will maintain the head in a neutral position off the ground in sidelying for as long as possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lateral neck flexor endurance
Time Frame: single testing session at enrollment
maximum hold time
single testing session at enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beighton Hyperlaxity Scale
Time Frame: at enrollment
Assessment of systemic hyperlaxity, 0-9 points, higher indicates greater hyperlaxity
at enrollment
Neck Disability Index
Time Frame: at enrollment
Questionnaire assessing impact of neck symptoms on function, 0-100 points, higher score indicates greater disability
at enrollment
Numeric pain rating scale
Time Frame: at enrollment
assessment of neck pain, 0-10 with higher indicating greater levels of pain
at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hartford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 26, 2021

Primary Completion (ACTUAL)

July 16, 2021

Study Completion (ACTUAL)

July 16, 2021

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 22, 2021

First Posted (ACTUAL)

February 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO02021000205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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