Neck PainNCT03493334
Visual Feedback in Chronic Neck Pain
A study testing Visual feedback and No visual feedback in people with Neck Pain, run by Aveiro University at 1 site in Portugal.
Trial summary
The objective of this study is to evaluate the impact of visual feedback of the posterior region of the cervical spine on pain intensity and range of motion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Visual feedback and No visual feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Apr 2018to 30 Jun 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To have idiopathic neck pain defined as neck pain unrelated to any known pathology or lesion felt at least once a week in the last 3 months, located between the nuchal line and a horizontal line passing through T1 and pain intensity of at least 3 in the visual analogue scale.
Who cannot join
- History of cervical or facial trauma, radiculopathy, history of surgery in the vertebral segment in question, congenital anomalies involving the spine (cervical, thoracic and lumbar spine) or any neurological or rheumatic pathology, and, finally, evidence of significant visual changes, or of deficits not corrected by lenses or glasses.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Clínica de Diagnóstico e Terapêutica - Hellman, Lda
Figueira da Foz Municipality
About this study
Official title: Impacto do Feedback Visual da região Posterior da Coluna Cervical, na Intensidade da Dor e Amplitude de Movimento, em Utentes Com Dor Cervical crónica idiopática
The objective of this study is to evaluate the impact of visual feedback of the posterior region of the cervical spine on pain intensity and range of motion.
Read the detailed description
60 patients with chronic idiopathic neck pain will be randomly assigned into one of two groups: a group receiving visual feedback when performing 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) and a group performing the same task without visual feedback. Participants will be assessed for pain intensity, pain location, disability, range of motion, kinesiophobia, catastrophizing and anxiety both at baseline and after visual the intervention (i.e., neck movements with and without visual feedback).
- Conditions
- Neck Pain
- Being tested
- Visual feedback, No visual feedback
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual feedbackOther
Visual feedback of the neck will be given to participants using two mirrors while performing neck movements.
No visual feedbackOther
Participants will be asked to perform active movements of their neck with the mirrors covered.
| Study group | Role | What they receive |
|---|---|---|
| Visual feedback | Experimental | Participants in this group will receive visual feedback of their neck when performing 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation). Receives: Other: Visual feedback |
| No visual feedback | Active comparator | Participants in this group will perform 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) without feedback. Receives: Other: No visual feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain intensity
Measured using a 10 cm visual analogue scale
Measured: Baseline
Neck pain intensity
Measured using a 10 cm visual analogue scale
Measured: Immediately after the intervention (at 30 minutes)
Secondary outcomes (15)
Pain location
Measured using a body chart
Measured: Baseline
Pain location
Measured using a body chart
Measured: Immediately after the intervention (at 30 minutes)
Time for pain to return to baseline levels
Measured with a chronometer
Measured: Immediately after the intervention (at 30 minutes)
Pain disability
Measured using the Neck Disability Questionnaire (range: 0-50 and higher scores are indicative of more disability)
Measured: Baseline
Pain disability
Measured using the Neck Disability Questionnaire (range: 0-50 and higher scores are indicative of more disability)
Measured: Immediately after the intervention (at 30 minutes)
Neck range of motion
Measured using a goniometer
Measured: Baseline
Neck range of motion
Measured using a goniometer
Measured: Immediately after the intervention (at 30 minutes)
Kinesiophobia
Measured using the Tampa Scale of Kinsesiophobia (Range: 13-52 and higher values are indicative of a higher fear of movement.
Measured: Baseline
Kinesiophobia
Measured using the Tampa Scale of Kinsesiophobia (Range: 13-52 and higher values are indicative of a higher fear of movement.
Measured: Immediately after the intervention (at 30 minutes)
Catastrophyzing
Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing)
Measured: Baseline
Catastrophyzing
Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing)
Measured: Immediately after the intervention (at 30 minutes)
Anxiety
Measured using the State-Trait Anxiety Scale, which consists of 2 sub-scales, one measures trait anxiety and the other measures state anxiety; both scales have an independent score that ranges from 20 to 80 and higher scores are indicative of higher anxiety.
Measured: Baseline
Anxiety
Measured using the State-Trait Anxiety Scale, which consists of 2 sub-scales, one measures trait anxiety and the other measures state anxiety; both scales have an independent score that ranges from 20 to 80 and higher scores are indicative of higher anxiety.
Measured: Immediately after the intervention (at 30 minutes)
Neck perception
Assessed by asking participants to draw their neck as they perceive it to be
Measured: Baseline
Neck perception
Assessed by asking participants to draw their neck as they perceive it to be
Measured: Immediately after the intervention (at 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start15 Apr 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
- Investigators
- Anabela Silva, PhD, Principal investigator, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493334
- Sponsor's protocol ID
- 12-CED/2018
- Status last verified
- Sep 2018
- First submitted
- 4 Apr 2018
- Last updated
- 11 Sep 2018
- 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 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacto do Feedback Visual da região Posterior da Coluna Cervical, na Intensidade da Dor e Amplitude de Movimento, em Utentes Com Dor Cervical crónica idiopática
- ClinicalTrials.gov ID
- NCT03493334
- Acronym / sponsor ID
- 12-CED/2018
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 10 Apr 2018 (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 objective of this study is to evaluate the impact of visual feedback of the posterior region of the cervical spine on pain intensity and range of motion.
Detailed description
60 patients with chronic idiopathic neck pain will be randomly assigned into one of two groups: a group receiving visual feedback when performing 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) and a group performing the same task without visual feedback. Participants will be assessed for pain intensity, pain location, disability, range of motion, kinesiophobia, catastrophizing and anxiety both at baseline and after visual the intervention (i.e., neck movements with and without visual feedback).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual feedback | Experimental | Other: Visual feedbackParticipants in this group will receive visual feedback of their neck when performing 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation). |
| No visual feedback | Active comparator | Other: No visual feedbackParticipants in this group will perform 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) without feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To have idiopathic neck pain defined as neck pain unrelated to any known pathology or lesion felt at least once a week in the last 3 months, located between the nuchal line and a horizontal line passing through T1 and pain intensity of at least 3 in the visual analogue scale.
Key exclusion criteria (1 listed)
- History of cervical or facial trauma, radiculopathy, history of surgery in the vertebral segment in question, congenital anomalies involving the spine (cervical, thoracic and lumbar spine) or any neurological or rheumatic pathology, and, finally, evidence of significant visual changes, or of deficits not corrected by lenses or glasses.
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 |
|---|---|---|
| Visual feedbackVisual feedback of the neck will be given to participants using two mirrors while performing neck movements. | Other | Visual feedback |
| No visual feedbackParticipants will be asked to perform active movements of their neck with the mirrors covered. | Other | No visual feedback |
Primary outcome
Neck pain intensity
Time frame: Baseline
Measured using a 10 cm visual analogue scale
Neck pain intensity
Time frame: Immediately after the intervention (at 30 minutes)
Measured using a 10 cm visual analogue scale
15 secondary outcomes
Pain location
Time frame: Baseline
Pain location
Time frame: Immediately after the intervention (at 30 minutes)
Time for pain to return to baseline levels
Time frame: Immediately after the intervention (at 30 minutes)
Pain disability
Time frame: Baseline
Pain disability
Time frame: Immediately after the intervention (at 30 minutes)
Neck range of motion
Time frame: Baseline
Neck range of motion
Time frame: Immediately after the intervention (at 30 minutes)
Kinesiophobia
Time frame: Baseline
Kinesiophobia
Time frame: Immediately after the intervention (at 30 minutes)
Catastrophyzing
Time frame: Baseline
Catastrophyzing
Time frame: Immediately after the intervention (at 30 minutes)
Anxiety
Time frame: Baseline
Anxiety
Time frame: Immediately after the intervention (at 30 minutes)
Neck perception
Time frame: Baseline
Neck perception
Time frame: Immediately after the intervention (at 30 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 11 Sep 2018.
- 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.
Anabela Silva, PhD principal investigator
Aveiro University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual feedback and No visual feedback in people with Neck Pain, run by Aveiro University at 1 site in Portugal.
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 1 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 11 Sep 2018. 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 Portugal. 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?
Neck pain intensity (time frame: Baseline). The study lists 2 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 11 Sep 2018.