Visual Feedback in Chronic Neck Pain

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Visual feedback; Other: No visual feedback

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Figueira Da Foz, Portugal
    • Clínica de Diagnóstico e Terapêutica - Hellman, Lda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Visual feedback; 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).	Other: Visual feedback; Visual feedback of the neck will be given to participants using two mirrors while performing neck movements.
ACTIVE_COMPARATOR: No visual feedback; Participants in this group will perform 10 repetitions of each of neck movements (flexion, extension, side-flexion and rotation) without feedback.	Other: No visual feedback; Participants will be asked to perform active movements of their neck with the mirrors covered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck pain intensity	Measured using a 10 cm visual analogue scale	Baseline
Neck pain intensity	Measured using a 10 cm visual analogue scale	Immediately after the intervention (at 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain location	Measured using a body chart	Baseline
Pain location	Measured using a body chart	Immediately after the intervention (at 30 minutes)
Time for pain to return to baseline levels	Measured with a chronometer	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)	Baseline
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)
Neck range of motion	Measured using a goniometer	Baseline
Neck range of motion	Measured using a goniometer	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.	Baseline
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)
Catastrophyzing	Measured using the Pain Catastrophyzing Scale (range: 0-52 and higher scores and indicative of higher pain catastrophyzing)	Baseline
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)
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
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)
Neck perception	Assessed by asking participants to draw their neck as they perceive it to be	Baseline
Neck perception	Assessed by asking participants to draw their neck as they perceive it to be	Immediately after the intervention (at 30 minutes)

Collaborators and Investigators

• Sponsor: Aveiro University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2018
• Primary Completion (ACTUAL): June 30, 2018
• Study Completion (ACTUAL): June 30, 2018

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (ACTUAL): April 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 12-CED/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No