Neck PainNCT02797002
Validity of Neck Extensor Muscles Endurance Test in Non-specific Chronic Neck Pain and Asymptomatic Subjects
An observational study of Neck Pain, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
Trial summary
Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's societies. Cervical muscles endurance has been commonly associated with the development of NP. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Assessment
- How many people
- 220 participants
- Where
- 1 siteIran
- Study dates
- Mar 2015to May 2017
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects with and without neck pain
Who may be able to join
- Subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale.
- Healthy subjects: no history of neck pain
Who cannot join
- History of cervical discopathy
- Any surgery on neck
- Traumatic neck injury
- Any congenital disorders
Trial locations and contacts
1 site in 1 country.
Iran1 site
University of Social Welfare and Rehabilitation Sciences
Tehran, 1985713831
About this study
Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's societies. Cervical muscles endurance has been commonly associated with the development of NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical therapists to evaluate muscle structure, function and activation patterns. The aim of this study is if change in muscle thickness can correlate with the results of the endurance testing.
- Conditions
- Neck Pain
- Being tested
- Assessment
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
| Study group | Role | What they receive |
|---|---|---|
| Chronic non specific neck pain | Experiencing neck pain for at least 3 months in the last year Receives: Other: Assessment | |
| Without neck pain (asymptomatic) | No history of neck pain Receives: Other: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexor and Extensor cervical muscles holding time (second)
Measured: 6 months
Anteroposterior diameter of the flexor and extensor cervical muscles (mm)
Measured: 6 months
Mediolateral diameter of the flexor and extensor cervical muscles (mm)
Measured: 6 months
Cross section area of the flexor and extensor cervical muscles (cm2)
Measured: 6 months
Neck disability questionnaire score
Measured: 6 months
Visual analogue scale score
Measured: 6 months
Secondary outcomes (1)
Pearson correlation coefficient of the cervical muscles holding time with Anteroposterior and border and cross section area of the flexor and extensor cervical muscles
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startMar 2015
- Primary completionApr 2017
- Study completionMay 2017
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Social Welfare and Rehabilitation Science
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. L. Ghamkhar, University of Social Welfare and Rehabilitation Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797002
- Sponsor's protocol ID
- IR.USWR.REC.1394.191
- Status last verified
- Oct 2017
- First submitted
- 3 Jun 2016
- Last updated
- 25 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Neck Extensor Muscles Endurance Test in Non-specific Chronic Neck Pain and Asymptomatic Subjects
- ClinicalTrials.gov ID
- NCT02797002
- Acronym / sponsor ID
- IR.USWR.REC.1394.191
- Conditions
- Neck Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of Social Welfare and Rehabilitation ScienceUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Jun 2016 (estimated)
- 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.
Neck pain (NP) is one of the most common and costly musculoskeletal complaints in today's societies. Cervical muscles endurance has been commonly associated with the development of NP. Real-time ultrasound imaging is a reliable and valid technique recently used by physical therapists to evaluate muscle structure, function and activation patterns. The aim of this study is if change in muscle thickness can correlate with the results of the endurance testing.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic non specific neck pain | – | Other: AssessmentExperiencing neck pain for at least 3 months in the last year |
| Without neck pain (asymptomatic) | – | Other: AssessmentNo history of neck pain |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects with and without neck pain
Key inclusion criteria (2 listed)
- Subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale.
- Healthy subjects: no history of neck pain
Key exclusion criteria (4 listed)
- History of cervical discopathy
- Any surgery on neck
- Traumatic neck injury
- Any congenital disorders
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 |
|---|---|---|
| Assessment | Other | Chronic non specific neck pain, Without neck pain (asymptomatic) |
Primary outcome
Flexor and Extensor cervical muscles holding time (second)
Time frame: 6 months
Anteroposterior diameter of the flexor and extensor cervical muscles (mm)
Time frame: 6 months
Mediolateral diameter of the flexor and extensor cervical muscles (mm)
Time frame: 6 months
Cross section area of the flexor and extensor cervical muscles (cm2)
Time frame: 6 months
Neck disability questionnaire score
Time frame: 6 months
Visual analogue scale score
Time frame: 6 months
1 secondary outcome
Pearson correlation coefficient of the cervical muscles holding time with Anteroposterior and border and cross section area of the flexor and extensor cervical muscles
Time frame: 6 months
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 25 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by University of Social Welfare and Rehabilitation Science at 1 site in Iran.
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 2 inclusion and 4 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 25 Oct 2017. 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 Iran. 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?
Flexor and Extensor cervical muscles holding time (second) (time frame: 6 months). The study lists 6 primary outcomes in all. 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 25 Oct 2017.