Pain, NeckNCT04014998
Effectiveness of Virtual Reality in Patients With Chronic Neck Pain
A study testing Virtual Reality in people with Pain, Neck and Virtual Reality, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Virtual reality application has been increasing in recent years for pain control, distraction in wound care, treatment of anxiety disorders and support for physical rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Neck, Virtual Reality, Proprioception
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2020to 10 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to have pain more than 3 months,
- to be sedentary,
- to have Neck Disability Index score more than 10.
Who cannot join
- to have neurological deficits, vestibular pathology, history of surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Virtual Reality Applications in Addition to Exercise Program in People With Chronic Neck Pain
Virtual reality application has been increasing in recent years for pain control, distraction in wound care, treatment of anxiety disorders and support for physical rehabilitation. For example, it has been found to be effective in reducing pain when used in addition to medical treatment during bandaging of severe burns. The studies related with chronic pain patients were stated that virtual reality application was found to be interactive and fun by patients. Therefore, The aim of this study was to investigate the effects of virtual reality on pain threshold, disability, balance, proprioception, exercise sustainability, muscular performance in neck region, quality of life and anxiety / depression in addition to the exercise program that includes stabilization exercises in patients with chronic neck pain.
- Conditions
- Pain, Neck, Virtual Reality, Proprioception, Balance
- Being tested
- Virtual Reality
- Keywords
- neck pain, virtual reality, proprioception, balance
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Also called Exercise
Virtual reality group will have virtual reality for 20 minutes in addition to motor control exercises for 20 minutes. Virtual reality will apply using Oculus Go. On the other hand control group will have only exercise for 40 minutes. Exercises will include same exercises in both groups, but exercise group will perform exercises twice compared to virtual reality group.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Virtual Reality + Exercise Receives: Other: Virtual Reality |
| Exercise | Other | Exercise Only Receives: Other: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint position sense error will assessed by Cervical Range of Motion device.
Joint position sense error will assessed by Cervical Range of Motion device.
Measured: Change from baseline joint position sense error (cervical flexion, extension, lateral flexions and rotations) after 6 weeks.
Balance will assessed by Dynamic Posturography.
Balance will assessed by Dynamic Posturography.
Measured: Change from baseline sensorial organization test (vestibular, visual and proprioceptive components), limits of stability (reaction time, movement velocity, endpoint excursion, maximum excursion, directional control) and unilateral stance after 6 weeks.
Secondary outcomes (9)
cervical lordosis angle
Angle will measure using the plane of the superior vertebral plateau of C7 vertebra and of the inferior plateau of C2.
Measured: Change from baseline cervical lordosis after 6 weeks.
Kinesiophobia will assessed by Tampa kinesiophobia Scale
Kinesiophobia will assessed by Tampa kinesiophobia Scale
Measured: Change from baseline kinesiophobia after 6 weeks.
Quality of life will assessed by Short-form 36.
Quality of life will assessed by Short-form 36.
Measured: Change from baseline quality of life after 6 weeks.
Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish).
Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish).
Measured: Change from baseline disability after 6 weeks.
Anxiety-depression will assessed by Hospital Anxiety-depression scale.
Anxiety-depression will assessed by Hospital Anxiety-depression scale.
Measured: Change from baseline anxiety-depression after 6 weeks.
Shoulder protraction and forward head posture were assessed by photography method.
Shoulder protraction and forward head posture were assessed by photography method.
Measured: Change from baseline shoulder protraction and forward head posture after 6 weeks.
Pain threshold will assessed by algometer device.
Pain threshold will assessed by algometer device.
Measured: Change from baseline pain threshold of both the right and left upper trapezius, the right and left articular pillar between cervical 1 and 2, the right and left cervical 5 and 6 after 6 weeks.
Pain intensity will assessed with Visual Analog Scale.
Pain intensity will assessed with Visual Analog Scale.
Measured: Change from baseline pain intensity after 6 weeks.
muscle strength will assessed by dynamometer and biofeedback device
muscle strength will assessed by dynamometer and biofeedback device
Measured: Change from baseline muscle strength after 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start30 Oct 2020
- Primary completion30 Sep 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, NeckStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Virtual Reality
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE ÇETİN, Hacettepe University
- Investigators
- Halil Kamil Öge, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014998
- Sponsor's protocol ID
- VR2805
- Status last verified
- Jun 2022
- First submitted
- 5 Jul 2019
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
PubMed 28356241Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.
PubMed 21779307
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Virtual Reality Applications in Addition to Exercise Program in People With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT04014998
- Acronym / sponsor ID
- VR2805
- Conditions
- Pain, Neck, Virtual Reality, Proprioception, Balance
- Keywords
- neck pain, virtual reality, proprioception, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Virtual reality application has been increasing in recent years for pain control, distraction in wound care, treatment of anxiety disorders and support for physical rehabilitation. For example, it has been found to be effective in reducing pain when used in addition to medical treatment during bandaging of severe burns. The studies related with chronic pain patients were stated that virtual reality application was found to be interactive and fun by patients. Therefore, The aim of this study was to investigate the effects of virtual reality on pain threshold, disability, balance, proprioception, exercise sustainability, muscular performance in neck region, quality of life and anxiety / depression in addition to the exercise program that includes stabilization exercises in patients with chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Virtual Reality
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual RealityVirtual Reality + Exercise |
| Exercise | Other | Other: Virtual RealityExercise Only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- to have pain more than 3 months,
- to be sedentary,
- to have Neck Disability Index score more than 10.
Key exclusion criteria (1 listed)
- to have neurological deficits, vestibular pathology, history of surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityAlso: ExerciseVirtual reality group will have virtual reality for 20 minutes in addition to motor control exercises for 20 minutes. Virtual reality will apply using Oculus Go. On the other hand control group will have only exercise for 40 minutes. Exercises will include same exercises in both groups, but exercise group will perform exercises twice compared to virtual reality group. | Other | Exercise, Virtual Reality |
Primary outcome
Joint position sense error will assessed by Cervical Range of Motion device.
Time frame: Change from baseline joint position sense error (cervical flexion, extension, lateral flexions and rotations) after 6 weeks.
Joint position sense error will assessed by Cervical Range of Motion device.
Balance will assessed by Dynamic Posturography.
Time frame: Change from baseline sensorial organization test (vestibular, visual and proprioceptive components), limits of stability (reaction time, movement velocity, endpoint excursion, maximum excursion, directional control) and unilateral stance after 6 weeks.
Balance will assessed by Dynamic Posturography.
9 secondary outcomes
cervical lordosis angle
Time frame: Change from baseline cervical lordosis after 6 weeks.
Kinesiophobia will assessed by Tampa kinesiophobia Scale
Time frame: Change from baseline kinesiophobia after 6 weeks.
Quality of life will assessed by Short-form 36.
Time frame: Change from baseline quality of life after 6 weeks.
Disability will assessed by Profile Fitness Mapping Questionnaire(Turkish).
Time frame: Change from baseline disability after 6 weeks.
Anxiety-depression will assessed by Hospital Anxiety-depression scale.
Time frame: Change from baseline anxiety-depression after 6 weeks.
Shoulder protraction and forward head posture were assessed by photography method.
Time frame: Change from baseline shoulder protraction and forward head posture after 6 weeks.
Pain threshold will assessed by algometer device.
Time frame: Change from baseline pain threshold of both the right and left upper trapezius, the right and left articular pillar between cervical 1 and 2, the right and left cervical 5 and 6 after 6 weeks.
Pain intensity will assessed with Visual Analog Scale.
Time frame: Change from baseline pain intensity after 6 weeks.
muscle strength will assessed by dynamometer and biofeedback device
Time frame: Change from baseline muscle strength after 6 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Background: PubMed 28356241Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.
- Background: PubMed 21779307Li A, Montano Z, Chen VJ, Gold JI. Virtual reality and pain management: current trends and future directions. Pain Manag. 2011 Mar;1(2):147-157. doi: 10.2217/pmt.10.15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Halil Kamil Öge study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Pain, Neck and Virtual Reality, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint position sense error will assessed by Cervical Range of Motion device. (time frame: Change from baseline joint position sense error (cervical flexion, extension, lateral flexions and rotations) after 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04014998, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.