NCT03493334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

April 4, 2018

Last Update Submit

September 10, 2018

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (15)

  • Pain location

    Baseline

  • Pain location

    Immediately after the intervention (at 30 minutes)

  • Time for pain to return to baseline levels

    Immediately after the intervention (at 30 minutes)

  • Pain disability

    Baseline

  • Pain disability

    Immediately after the intervention (at 30 minutes)

  • +10 more secondary outcomes

Study Arms (2)

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).

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.

Other: No visual feedback

Interventions

Visual feedbackOTHER

Visual feedback of the neck will be given to participants using two mirrors while performing neck movements.

Visual feedback
No visual feedbackOTHER

Participants will be asked to perform active movements of their neck with the mirrors covered.

No visual feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica de Diagnóstico e Terapêutica - Hellman, Lda

Figueira da Foz Municipality, Portugal

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Feedback, Sensory

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, PsychologyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, PsychologicalFeedback, PhysiologicalHomeostasisPhysiological Phenomena

Study Officials

  • Anabela Silva, PhD

    Aveiro University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 10, 2018

Study Start

April 15, 2018

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)