Neck PainNCT05829564
Virtual Reality and Cervical Mobilization
A study testing virtual reality, cervical mobilization and exercise in people with Neck Pain and Virtual Reality, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effects of virtual reality and cervical mobilization on proprioception, balance parameters, pain, disability level, quality of life and overall felt effect in individuals with chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Virtual Reality
- What is being tested?
- virtual reality, cervical mobilization and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2023to 15 Sep 2023
- 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
- Neck pain persisting for at least 3 months
- Being between the ages of 18-65,
- Being sedentary (not included in any physical therapy program in the last 6 months), ->10 points from the Neck Disability Index
Who cannot join
- History of previous spinal surgery
- Neurological, cardiopulmonary, musculoskeletal disease affecting physical performance
- Any pathology in the shoulder joint
- Spinal trauma history
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Virtual Reality and Cervical Mobilization in Individuals With Chronic Neck Pain
The aim of this study is to compare the effects of virtual reality and cervical mobilization on proprioception, balance parameters, pain, disability level, quality of life and overall felt effect in individuals with chronic neck pain. In addition, it is aimed to qualitatively evaluate the virtual reality perspectives of individuals with chronic neck pain.
- Conditions
- Neck Pain, Virtual Reality
- Being tested
- virtual reality, cervical mobilization, exercise
- 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
The individuals participating in the study will experience virtual reality.
cervical mobilizationOther
The individuals participating in the study will be applied cervical mobilization techniques.
exerciseOther
The individuals participating in the study will performed neck-specific exercises.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality+Exercise | Experimental | An exercise program consisting of stretching exercises, posture exercises and breathing exercises and lasting approximately 20-30 minutes will be applied to the individuals in all 3 groups.
The virtual reality group will performe virtual reality for an additional 20 minutes. (Oculus GO) Receives: Other: virtual reality; Other: exercise |
| cervical mobilization+Exercise | Experimental | An exercise program consisting of stretching exercises, posture exercises and breathing exercises and lasting approximately 20-30 minutes will be applied to the individuals in all 3 groups.
Mobilization techniques that will mobilize the cervical region will be applied to the cervical mobilization group for 20 minutes. Receives: Other: cervical mobilization; Other: exercise |
| Control | Other | Control group will only perform an exercise program. Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint position sense error
Proprioception in all cervical directions will assessed by Cervical Range of Motion device.
Measured: Change from Baseline balance after 4 weeks/10 sessions.
Baropodometer assessments-Pressure distribution
Pressure distribution will assess with FreeMed baropodometric platform and will record as percentage.
Measured: Change from Baseline proprioception after 4 weeks/10 sessions.
Baropodometer assessments- Center of gravity
Center of gravity will assess with FreeMed baropodometric platform and will record as mm.
Measured: Change from Baseline proprioception after 4 weeks/10 sessions.
Baropodometer assessments- Oscillations
Oscillations will assess with FreeMed baropodometric platform.
Measured: Change from Baseline proprioception after 4 weeks/10 sessions.
Baropodometer assessments- Sway velocity
Sway velocity will assess with FreeMed baropodometric platform and will record as degrees.
Measured: Change from Baseline proprioception after 4 weeks/10 sessions.
Functional Balance
10 meter walking speed and four square step-test will be combined to report dynamic balance.
Measured: Change from Baseline proprioception after 4 weeks/10 sessions.
Secondary outcomes (4)
Cervical Pain
Visual Analog Scale will be used to assess this outcome measure.
Measured: Change from Baseline cervical pain after 4 weeks/ 10 sessions.
Functional disability
Neck Disability Index will be used to assess this outcome measure.
Measured: Change from Baseline functional disability after 4 weeks/ 10 sessions.
quality of life about cervical pain
SF-36 will be used to assess this outcome measure.
Measured: Change from Baseline quality of life about cervical pain after 4 weeks/ 10 sessions.
Global perceived effect
Global perceived effect scale will be used to assess this outcome measure/ 10 sessions.
Measured: Change from Baseline Global perceived effect after 4 weeks/ 10 sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start10 May 2023
- Primary completion1 Jun 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HATİCE ÇETİN, Hacettepe University
- Investigators
- Oge, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05829564
- Sponsor's protocol ID
- VRMOB
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Virtual Reality and Cervical Mobilization in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT05829564
- Acronym / sponsor ID
- VRMOB
- Conditions
- Neck Pain, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 25 Apr 2023 (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.
The aim of this study is to compare the effects of virtual reality and cervical mobilization on proprioception, balance parameters, pain, disability level, quality of life and overall felt effect in individuals with chronic neck pain. In addition, it is aimed to qualitatively evaluate the virtual reality perspectives of individuals with chronic neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| virtual reality+Exercise | Experimental | Other: virtual reality, Other: exerciseAn exercise program consisting of stretching exercises, posture exercises and breathing exercises and lasting approximately 20-30 minutes will be applied to the individuals in all 3 groups. The virtual reality group will performe virtual reality for an additional 20 minutes. (Oculus GO) |
| cervical mobilization+Exercise | Experimental | Other: cervical mobilization, Other: exerciseAn exercise program consisting of stretching exercises, posture exercises and breathing exercises and lasting approximately 20-30 minutes will be applied to the individuals in all 3 groups. Mobilization techniques that will mobilize the cervical region will be applied to the cervical mobilization group for 20 minutes. |
| Control | Other | Other: exerciseControl group will only perform an exercise program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Neck pain persisting for at least 3 months
- Being between the ages of 18-65,
- Being sedentary (not included in any physical therapy program in the last 6 months), ->10 points from the Neck Disability Index
Key exclusion criteria (5 listed)
- History of previous spinal surgery
- Neurological, cardiopulmonary, musculoskeletal disease affecting physical performance
- Any pathology in the shoulder joint
- Spinal trauma history
- Pregnancy
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 realityThe individuals participating in the study will experience virtual reality. | Other | virtual reality+Exercise |
| cervical mobilizationThe individuals participating in the study will be applied cervical mobilization techniques. | Other | cervical mobilization+Exercise |
| exerciseThe individuals participating in the study will performed neck-specific exercises. | Other | Control, cervical mobilization+Exercise, virtual reality+Exercise |
Primary outcome
Joint position sense error
Time frame: Change from Baseline balance after 4 weeks/10 sessions.
Proprioception in all cervical directions will assessed by Cervical Range of Motion device.
Baropodometer assessments-Pressure distribution
Time frame: Change from Baseline proprioception after 4 weeks/10 sessions.
Pressure distribution will assess with FreeMed baropodometric platform and will record as percentage.
Baropodometer assessments- Center of gravity
Time frame: Change from Baseline proprioception after 4 weeks/10 sessions.
Center of gravity will assess with FreeMed baropodometric platform and will record as mm.
Baropodometer assessments- Oscillations
Time frame: Change from Baseline proprioception after 4 weeks/10 sessions.
Oscillations will assess with FreeMed baropodometric platform.
Baropodometer assessments- Sway velocity
Time frame: Change from Baseline proprioception after 4 weeks/10 sessions.
Sway velocity will assess with FreeMed baropodometric platform and will record as degrees.
Functional Balance
Time frame: Change from Baseline proprioception after 4 weeks/10 sessions.
10 meter walking speed and four square step-test will be combined to report dynamic balance.
4 secondary outcomes
Cervical Pain
Time frame: Change from Baseline cervical pain after 4 weeks/ 10 sessions.
Functional disability
Time frame: Change from Baseline functional disability after 4 weeks/ 10 sessions.
quality of life about cervical pain
Time frame: Change from Baseline quality of life about cervical pain after 4 weeks/ 10 sessions.
Global perceived effect
Time frame: Change from Baseline Global perceived effect after 4 weeks/ 10 sessions.
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 29 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Oge 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, cervical mobilization and exercise in people with Neck Pain 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 5 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 29 Mar 2024. 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 (time frame: Change from Baseline balance after 4 weeks/10 sessions.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2024.