Back to resultsVisual Feedback in Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Visual feedback
No visual feedback
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain
Eligibility Criteria
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.
Sites / Locations
- Clínica de Diagnóstico e Terapêutica - Hellman, Lda
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Visual feedback
No visual feedback
Arm Description
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).
Participants in this group will perform 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) without feedback.
Outcomes
Primary Outcome Measures
Neck pain intensity
Measured using a 10 cm visual analogue scale
Neck pain intensity
Measured using a 10 cm visual analogue scale
Secondary Outcome Measures
Pain location
Measured using a body chart
Pain location
Measured using a body chart
Time for pain to return to baseline levels
Measured with a chronometer
Pain disability
Measured using the Neck Disability Questionnaire (range: 0-50 and higher scores are indicative of more disability)
Pain disability
Measured using the Neck Disability Questionnaire (range: 0-50 and higher scores are indicative of more disability)
Neck range of motion
Measured using a goniometer
Neck range of motion
Measured using a goniometer
Kinesiophobia
Measured using the Tampa Scale of Kinsesiophobia (Range: 13-52 and higher values are indicative of a higher fear of movement.
Kinesiophobia
Measured using the Tampa Scale of Kinsesiophobia (Range: 13-52 and higher values are indicative of a higher fear of movement.
Catastrophyzing
Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing)
Catastrophyzing
Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing)
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.
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.
Neck perception
Assessed by asking participants to draw their neck as they perceive it to be
Neck perception
Assessed by asking participants to draw their neck as they perceive it to be
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03493334
Brief Title
Visual Feedback in Chronic Neck Pain
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visual feedback
Arm Type
Experimental
Arm Description
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).
Arm Title
No visual feedback
Arm Type
Active Comparator
Arm Description
Participants in this group will perform 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) without feedback.
Intervention Type
Other
Intervention Name(s)
Visual feedback
Intervention Description
Visual feedback of the neck will be given to participants using two mirrors while performing neck movements.
Intervention Type
Other
Intervention Name(s)
No visual feedback
Intervention Description
Participants will be asked to perform active movements of their neck with the mirrors covered.
Primary Outcome Measure Information:
Title
Neck pain intensity
Description
Measured using a 10 cm visual analogue scale
Time Frame
Baseline
Title
Neck pain intensity
Description
Measured using a 10 cm visual analogue scale
Time Frame
Immediately after the intervention (at 30 minutes)
Secondary Outcome Measure Information:
Title
Pain location
Description
Measured using a body chart
Time Frame
Baseline
Title
Pain location
Description
Measured using a body chart
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Time for pain to return to baseline levels
Description
Measured with a chronometer
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Pain disability
Description
Measured using the Neck Disability Questionnaire (range: 0-50 and higher scores are indicative of more disability)
Time Frame
Baseline
Title
Pain disability
Description
Measured using the Neck Disability Questionnaire (range: 0-50 and higher scores are indicative of more disability)
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Neck range of motion
Description
Measured using a goniometer
Time Frame
Baseline
Title
Neck range of motion
Description
Measured using a goniometer
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Kinesiophobia
Description
Measured using the Tampa Scale of Kinsesiophobia (Range: 13-52 and higher values are indicative of a higher fear of movement.
Time Frame
Baseline
Title
Kinesiophobia
Description
Measured using the Tampa Scale of Kinsesiophobia (Range: 13-52 and higher values are indicative of a higher fear of movement.
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Catastrophyzing
Description
Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing)
Time Frame
Baseline
Title
Catastrophyzing
Description
Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing)
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Anxiety
Description
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.
Time Frame
Baseline
Title
Anxiety
Description
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.
Time Frame
Immediately after the intervention (at 30 minutes)
Title
Neck perception
Description
Assessed by asking participants to draw their neck as they perceive it to be
Time Frame
Baseline
Title
Neck perception
Description
Assessed by asking participants to draw their neck as they perceive it to be
Time Frame
Immediately after the intervention (at 30 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anabela Silva, PhD
Organizational Affiliation
Aveiro University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica de Diagnóstico e Terapêutica - Hellman, Lda
City
Figueira Da Foz
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
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Visual Feedback in Chronic Neck Pain
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