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 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 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 of 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 10 4642211
bischebeck@sjcn.nl
Sponsor type
University/education
Website
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