Neck PainTeleneckNCT04646720
Teleassessment in Neck Pain
An observational study of Neck Pain and Assessment, Self, run by Universidad de Granada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Assessment, Self, Kinesiophobia
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 30 May 2021
- 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: Patients with chronic neck pain
Who may be able to join
- Presence of neck pain
- Between 18 and 65 years
- Accepted to sign the informed consent
Who cannot join
- Cognitive impairment.
- Traumatic accidents.
- Other orthopedic or neurologic pathology.
About this study
Official title: Teleassessment in Neck Pain Patients: an Observational Study
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.
- Conditions
- Neck Pain, Assessment, Self, Kinesiophobia
- Medical subject headings
- Neck Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neck pain patients | Patients with neck pain evaluated with new technologies and face-to-face |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in range of movement
Changes in range of movement were measured with goniometry and expressed in degrees.
Measured: Baseline
Changes in trigger points
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.
Measured: Baseline
Changes in neck endurance (anterior)
Changes in neck endurance were measured using an endurance test for the anterior neck muscles. The time performing the test was registered.
Measured: Baseline
Changes in neck endurance (posterior)
Changes in neck endurance were measured using an endurance test for the posterior neck muscles. The time performing the test was registered.
Measured: Baseline
Changes in quality of life
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.
Measured: Baseline
Changes in quality of life (Visual Analogue Scale)
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.
Measured: Baseline
Secondary outcomes (2)
Changes in kinesiophobia
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.
Measured: Baseline
Changes in functionality
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion30 Mar 2021 (estimated)
- Study completion30 May 2021 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646720
- Sponsor's protocol ID
- DF0092UG
- Acronym
- Teleneck
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- 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 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teleassessment in Neck Pain Patients: an Observational Study
- ClinicalTrials.gov ID
- NCT04646720
- Acronym / sponsor ID
- Teleneck / DF0092UG
- Conditions
- Neck Pain, Assessment, Self, Kinesiophobia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 30 Nov 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neck pain patients | – | –Patients with neck pain evaluated with new technologies and face-to-face |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic neck pain
Key inclusion criteria (3 listed)
- Presence of neck pain
- Between 18 and 65 years
- Accepted to sign the informed consent
Key exclusion criteria (3 listed)
- Cognitive impairment.
- Traumatic accidents.
- Other orthopedic or neurologic pathology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in range of movement
Time frame: Baseline
Changes in range of movement were measured with goniometry and expressed in degrees.
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.
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.
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.
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.
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.
2 secondary outcomes
Changes in kinesiophobia
Time frame: Baseline
Changes in functionality
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Assessment, Self, run by Universidad de Granada.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Changes in range of movement (time frame: Baseline). 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 30 Nov 2020.