Condition category
Signs and Symptoms
Date applied
23/06/2016
Date assigned
23/06/2016
Last edited
20/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Neck pain is a very common condition, which can be cause great discomfort and restriction of movement. Patients with neck pain often have visual problems however the reason for this is unknown. One possibility is that the amount of neck movement a person undertakes can influence the eye function. Many patients with neck pain may move their necks less to avoid pain, which may be causing the visual problems. The aim of this study is to look at whether a lot of movement or restricted movement of the neck has an effect on eye function in healthy people with no neck pain, to try to find the out if there is link between neck movement and visual problems.

Who can participate?
Adults with no neck pain who are able to move their necks freely and have normal or corrected-to-normal vision

What does the study involve?
Participants are randomly allocated to undertake two tests spaced one week apart in a different order. Before and 20 minutes after each test, participants have their eye function (measuring of the eye stabilization reflexes) measured. One test involves moving the neck around extensively for 20 minutes. The other test involves wearing a stiff neck collar that restricts movement for one hour.
The measurement of eye function will be in a darkened room and lasts around 20 minutes. It involves having to look straight forward while the chair they are sitting on is rotating, while the position of their eyes is measured with an infrared eye tracking device. Two weeks later, 11 participants return to repeat the condition with the neck collar, after wearing it for two hours. The eye function tests are repeated before and 20 minutes after wearing the collar.

What are the possible benefits and risks of participating?
There are no direct benefits for participants taking part in this study.

Where is the study run from?
Erasmus MC (Netherlands)

When is the study starting and how long is it expected to run for?
August 2014 to May 2015

Who is funding the study?
Erasmus MC (Netherlands)

Who is the main contact?
Miss Britta Ischebeck
bischebeck@sjcn.nl

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Britta Ischebeck

ORCID ID

http://orcid.org/0000-0003-0801-5242

Contact details

Department of Neuroscience
Erasmus MC
's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 (0)10 4642211
bischebeck@sjcn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016_6

Study information

Scientific title

The influence of cervical movement on eye stabilization reflexes: a randomized cross-over trial

Acronym

Study hypothesis

The aim of this study is to investigate the influence of the amount of cervical movement on the cervico-ocular reflex (COR) and vestibulo-ocular reflex (VOR) in healthy individuals.

Ethics approval

Ethical board of the Erasmus MC, 19/07/2011, ref: MEC-2011-273

Study design

Single-centre randomised cross-over trial

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

Neck pain

Intervention

In the main experiment, two types of intervention are applied to all participants in a cross-over design: hypokinesia and hyperkinesia. Directly before and after the intervention, the eye stabilization reflexes and the active range of motion are measured.

In the hypokinesia intervention, the neck is immobilized by using a stiff neck collar (size 4, Laerdal Stifneck® Select™) for one hour.

In the hyperkinesia intervention, active neck movement in all possible directions of movement is evoked by having the participants move their neck excessively in all directions for twenty minutes.

Each participant receives both interventions on two different days separated by 6 or 7 days. The order of the two interventions was pseudo-randomized and balanced across participants.

In the replication experiment, eleven participants wear the neck collar for two hours (prolonged hypokinesia). This experiment takes place two weeks after the end of the main experiment.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Amplitude of the cervico- ocular reflex (COR) and vestibulo-ocular reflex (VOR) is measured with a rotational chair with infrared eye tracking device pre and post each intervention.

Secondary outcome measures

The amount of the active cervical range of motion (CROM) in both the horizontal and vertical plane was also measured device (Performance Attainments Associates, USA) pre and post each intervention.

Overall trial start date

01/08/2014

Overall trial end date

01/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years or older
2. No neck pain
3. Able to move their neck
4. Able to sit on a chair for 20 minutes
5. Normal or corrected-to-normal visual acuity

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Neck pain
2. History of neck trauma
3. Use of tranquilizing medication

Recruitment start date

01/12/2014

Recruitment end date

01/05/2015

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus MC
Department of Neuroscience 's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Sponsor information

Organisation

Erasmus MC

Sponsor details

's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands
+31 (0)10 4642211
bischebeck@sjcn.nl

Sponsor type

University/education

Website

www.erasmusmc.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medisch Centrum

Alternative name(s)

Erasmus Medical Center, Erasmus MC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Results and Publications

Publication and dissemination plan

The authors intend to publish the results of the study in the autumn of 2016 in the journal 'Archives of Physical Medicine and Rehabilitation'

Intention to publish date

01/08/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29147731

Publication citations

Additional files

Editorial Notes

20/11/2017: Publication reference added.