NCT04937985

Brief Summary

The aim of this study was to examine the validity and test-retest reliability of unsupported upper extremity exercise test (UULEX) in individuals with chronic neck pain. Patients with neck pain lasting at least 3 months will be included in the study. It is planned to examine the validity and test-retest reliability of the UULEX test in that patient groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

June 18, 2021

Last Update Submit

June 18, 2021

Conditions

Keywords

chronic neck painupper extremity testvalidityreliability

Outcome Measures

Primary Outcomes (1)

  • Functional capacity test

    Unsupported Upper Limb Exercise Test

    15 minutes- Change from baseline values at 1 week

Secondary Outcomes (7)

  • Functional capacity test

    6 minutes (single application)

  • Upper extremity endurance test

    30 seconds (single application)

  • Disability Level

    15 minutes (single application)

  • Upper Extremity Function

    15 minutes (single application)

  • Severity of Pain

    3 minutes (single application)

  • +2 more secondary outcomes

Study Arms (1)

UULEX Test Group

Patients with chronic neck pain

Other: Performance Tests

Interventions

Performance tests consist of Six Minute Pegboard Ring Test, 30-Second Push-Up Test and Arm, Shoulder and Hand Injury Questionnaire (DASH), Neck Disability Index, New York Posture Rating Chart and Short Form-36 Health Survey.

UULEX Test Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

44 patients with neck pain lasting at least 3 months and being volunteer to participate in our study

You may qualify if:

  • years old

You may not qualify if:

  • Presence of additional disease affecting upper extremity and hand functions (carpal tunnel syndrome, trigger finger, impingement syndrome,thoracic outlet syndrome, lateral and medial epicondylitis, hand osteoarthritis, etc.),
  • having undergone upper extremity or cervical region surgery
  • cervical radiculopathy, rheumatic disease, presence of neurological symptoms
  • According to the Visual Analogue Scale (VAS), neck pain intensity in activity is less than 3,
  • Acute or chronic respiratory illness
  • Cardiac disease
  • Problem recognizing verbal commands
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İlknur Naz Gürşan

Izmir, 35620, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Zeynep Karazeybek

    Izmir Katip Celebi University

    PRINCIPAL INVESTIGATOR
  • İlknur Naz

    Izmir Katip Celebi University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof

Study Record Dates

First Submitted

June 18, 2021

First Posted

June 24, 2021

Study Start

November 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

June 24, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations