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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03493334
Other study ID # 12-CED/2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date June 30, 2018

Study information

Verified date September 2018
Source Aveiro University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Visual feedback
Visual feedback of the neck will be given to participants using two mirrors while performing neck movements.
No visual feedback
Participants will be asked to perform active movements of their neck with the mirrors covered.

Locations

Country Name City State
Portugal Clínica de Diagnóstico e Terapêutica - Hellman, Lda Figueira Da Foz

Sponsors (1)

Lead Sponsor Collaborator
Aveiro University

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck pain intensity Measured using a 10 cm visual analogue scale Baseline
Primary Neck pain intensity Measured using a 10 cm visual analogue scale Immediately after the intervention (at 30 minutes)
Secondary Pain location Measured using a body chart Baseline
Secondary Pain location Measured using a body chart Immediately after the intervention (at 30 minutes)
Secondary Time for pain to return to baseline levels Measured with a chronometer Immediately after the intervention (at 30 minutes)
Secondary Pain disability Measured using the Neck Disability Questionnaire (range: 0-50 and higher scores are indicative of more disability) Baseline
Secondary Pain disability Measured using the Neck Disability Questionnaire (range: 0-50 and higher scores are indicative of more disability) Immediately after the intervention (at 30 minutes)
Secondary Neck range of motion Measured using a goniometer Baseline
Secondary Neck range of motion Measured using a goniometer Immediately after the intervention (at 30 minutes)
Secondary Kinesiophobia Measured using the Tampa Scale of Kinsesiophobia (Range: 13-52 and higher values are indicative of a higher fear of movement. Baseline
Secondary Kinesiophobia Measured using the Tampa Scale of Kinsesiophobia (Range: 13-52 and higher values are indicative of a higher fear of movement. Immediately after the intervention (at 30 minutes)
Secondary Catastrophyzing Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing) Baseline
Secondary Catastrophyzing Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing) Immediately after the intervention (at 30 minutes)
Secondary 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. Baseline
Secondary 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. Immediately after the intervention (at 30 minutes)
Secondary Neck perception Assessed by asking participants to draw their neck as they perceive it to be Baseline
Secondary Neck perception Assessed by asking participants to draw their neck as they perceive it to be Immediately after the intervention (at 30 minutes)
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