ISRCTN ISRCTN55660633
DOI https://doi.org/10.1186/ISRCTN55660633
Secondary identifying numbers 2016_6
Submission date
23/06/2016
Registration date
23/06/2016
Last edited
20/11/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mrs Britta Ischebeck
Scientific

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

ORCiD logoORCID ID 0000-0003-0801-5242
Phone +31 (0)10 4642211
Email bischebeck@sjcn.nl

Study information

Study designSingle-centre randomised cross-over trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Other
Study typeOther
Participant information sheet No participant information sheet available
Scientific titleThe influence of cervical movement on eye stabilization reflexes: a randomized cross-over trial
Study objectivesThe 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(s)Ethical board of the Erasmus MC, 19/07/2011, ref: MEC-2011-273
Health condition(s) or problem(s) studiedNeck pain
InterventionIn 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 typeBehavioural
Primary outcome measureAmplitude 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 measuresThe 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 study start date01/08/2014
Completion date01/05/2015

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants20
Key inclusion criteria1. 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
Key exclusion criteria1. Neck pain
2. History of neck trauma
3. Use of tranquilizing medication
Date of first enrolment01/12/2014
Date of final enrolment01/05/2015

Locations

Countries of recruitment

  • Netherlands

Study participating centre

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

Sponsor information

Erasmus MC
University/education

's-Gravendijkwal 230
Rotterdam
3015 CE
Netherlands

Phone +31 (0)10 4642211
Email bischebeck@sjcn.nl
Website www.erasmusmc.nl
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Hospital/treatment centre

Erasmus Medisch Centrum
Government organisation / Universities (academic only)
Alternative name(s)
Erasmus Medical Center, Erasmus MC, Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Universitair Medisch Centrum Rotterdam, Erasmus Universitair Medisch Centrum Rotterdam, EMC
Location
Netherlands

Results and Publications

Intention to publish date01/08/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe authors intend to publish the results of the study in the autumn of 2016 in the journal 'Archives of Physical Medicine and Rehabilitation'
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2018 Yes No

Editorial Notes

20/11/2017: Publication reference added.