Neck PainNCT04937985
Unsupported Upper Extremity Exercise Test in Chronic Neck Pain
An observational study of Neck Pain and Upper Extremity Dysfunction, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Upper Extremity Dysfunction
- What is being tested?
- Performance Tests
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 1 Feb 2021
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 44 patients with neck pain lasting at least 3 months and being volunteer to participate in our study
Who may be able to join
- 18-65 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity and Test-Retest Reliability of Unsupported Upper Limb Exercise Test in Patients With Chronic Neck Pain
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.
Read the detailed description
Persons with chronic neck pain may limit the functional use of their upper extremities. It is recommended to determine appropriate upper extremity measurement methods in patients with chronic neck pain. Therefore 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.
Six Minute Pegboard Ring Test, 30-Second Push-Up Test and Arm, Shoulder and Hand Injury Questionnaire (DASH), Visual Analog Scale, Neck Disability Index, New York Posture Rating Chart and Short Form-36 Health Survey were used to evaluate the validity of the test. For test-retest reliability, the unsupported upper extremity test was repeated 1 week later by the same investigator.
- Conditions
- Neck Pain, Upper Extremity Dysfunction
- Being tested
- Performance Tests
- Keywords
- chronic neck pain, upper extremity test, validity, reliability
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance TestsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| UULEX Test Group | Patients with chronic neck pain Receives: Other: Performance Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity test
Unsupported Upper Limb Exercise Test
Measured: 15 minutes- Change from baseline values at 1 week
Secondary outcomes (7)
Functional capacity test
Six minute pegboard ring test
Measured: 6 minutes (single application)
Upper extremity endurance test
30 Second Push Up Test
Measured: 30 seconds (single application)
Disability Level
Neck Disability Index: Scores range from 0 to 50, with higher scores indicating higher disability
Measured: 15 minutes (single application)
Upper Extremity Function
Disability of Arm Shoulder and Hand Injury Questionnaire: Scores range from 0 to 100, with higher scores indicating higher disability
Measured: 15 minutes (single application)
Severity of Pain
Visual analog Scale:Scores range from 0 to 100, with higher scores indicating higher pain severity
Measured: 3 minutes (single application)
Postural Assessment
New York Posture Rating Chart :Scores range from 13 to 65, with higher scores indicating better posture
Measured: 10 minutes (single application)
Quality of Life Assessment
Short Form-30 Health Survey: Scores range from 0 to 100, with higher scores indicating better quality of life
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Nov 2020
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
- Investigators
- Zeynep Karazeybek, Principal investigator, Izmir Katip Celebi Universityİlknur Naz, Study director, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937985
- Sponsor's protocol ID
- IKC3
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 24 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Test-Retest Reliability of Unsupported Upper Limb Exercise Test in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04937985
- Acronym / sponsor ID
- IKC3
- Conditions
- Neck Pain, Upper Extremity Dysfunction
- Keywords
- chronic neck pain, upper extremity test, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Persons with chronic neck pain may limit the functional use of their upper extremities. It is recommended to determine appropriate upper extremity measurement methods in patients with chronic neck pain. Therefore 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.
Six Minute Pegboard Ring Test, 30-Second Push-Up Test and Arm, Shoulder and Hand Injury Questionnaire (DASH), Visual Analog Scale, Neck Disability Index, New York Posture Rating Chart and Short Form-36 Health Survey were used to evaluate the validity of the test. For test-retest reliability, the unsupported upper extremity test was repeated 1 week later by the same investigator.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UULEX Test Group | – | Other: Performance TestsPatients with chronic neck pain |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 44 patients with neck pain lasting at least 3 months and being volunteer to participate in our study
Key inclusion criteria (1 listed)
- 18-65 years old
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Performance TestsPerformance 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. | Other | UULEX Test Group |
Primary outcome
Functional capacity test
Time frame: 15 minutes- Change from baseline values at 1 week
Unsupported Upper Limb Exercise Test
7 secondary outcomes
Functional capacity test
Time frame: 6 minutes (single application)
Upper extremity endurance test
Time frame: 30 seconds (single application)
Disability Level
Time frame: 15 minutes (single application)
Upper Extremity Function
Time frame: 15 minutes (single application)
Severity of Pain
Time frame: 3 minutes (single application)
Postural Assessment
Time frame: 10 minutes (single application)
Quality of Life Assessment
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Karazeybek principal investigator
Izmir Katip Celebi University
İlknur Naz study director
Izmir Katip Celebi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Upper Extremity Dysfunction, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional capacity test (time frame: 15 minutes- Change from baseline values at 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.