Neck PainNCT03903380
Manual Therapy and Exercise With Mixed Reality With Hololens® Exercise Protocol in Chronic Neck Pain Patiens.
A study testing Manual Therapy and Augmented reality exercise protocol in people with Neck Pain and Chronic Pain, run by Centro Universitario La Salle at 1 site in Spain.
Trial summary
Currently, cervical pain is the second most frequent musculoskeletal disorder, which generates an important impact on the function and quality of life. It is estimated that its anual prevalence for the general population can reach 50%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- Manual Therapy and Augmented reality exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 22 Apr 2019to 1 Apr 2020
- 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
- - Men and women.
- Age: 18-65 years old.
- Persistent neck pain for at least 3 month or intermittent neck pain for 6 month or more.
- 5 points or 10% at the Neck Disability Index questionnaire.
Who cannot join
- Cervical whiplash (10 years before)
- Cervical fractures.
- Vestibular pathology.
- Epilepsy or other neurological condition.
- Systemic diseases.
- Cardiovascular or respiratory disorders that affect physical performance.
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- Lasik eye surgery.
- Fibromyalgia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Manual Therapy and Exercise With Mixed Reality With Hololens® Exercise Protocol in Chronic Neck Pain Subjects: Clinical Trial
Currently, cervical pain is the second most frequent musculoskeletal disorder, which generates an important impact on the function and quality of life. It is estimated that its anual prevalence for the general population can reach 50%.
Non-specific cervical pain attends without signs or symptoms of structural or neurological pathology, its etiology is unknown. However, it is related with joint and muscular structures. It has been observed a decrease in the strength and endurace of the deep cervical flexor muscles in 70% of patients with cervical pain; as well as motor control déficit and coordination alterations in the sinergy between the activity of the superficial and deep musculature.
Read more
Also, phycosocial factors, as for example: behaviors of fear-avoidance, catastrophism, hypervigilancy, psychosocial stress and negative adaptative neuroplastic changes, may have an importante role in chronic musculoskeletal pain.
In the last years, RV has been used in clinical rehabilitation, being a reliable and valid tool, which allows the patient distration to virtual world and they have offered results like: decreased pain and fear of movement and also improvements in motor performance and neuroplasticity processes.
The aim of this single-blinded randomized novel pilot study is to observe the effects generated in motor variables, when a protocol of manual therapy combined with augmented reality as a method of exercise in subjects with non-specific cervical pain is applied; in comparaison with a protocol of manual therapy combined with conventional cervical exercises.
Different variables will be measured at the beginning and at the end of intervention. Also, they will be measured one month after the intervention to observe the changes produced in short term. These variables are: pain, function, satisfaction, propioception, endurance, as well as phychological and somatosensory variables.
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Manual Therapy and Usual care exercise protocol for neck pain, Manual Therapy and Augmented reality exercise protocol
- Keywords
- Virtual reality, Therapeuthic exercise, Quantitative sensory testing
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy and Usual care exercise protocol for neck painOther
Manual Therapy protocol between four to eight sessions and exercise protocol will be progressively added to the intervention (from the fouth session of MT approximately).
Manual Therapy and Augmented reality exercise protocolOther
Manual Therapy protocol between four to eight sessions and Augmented reality exercise protocol will be progressively added to the intervention (from the fouth session of MT approximately).
| Study group | Role | What they receive |
|---|---|---|
| MT treatment + Usual care exercise | Active comparator | The intervention will be divided into two parts, the first one where MT treatment will take place and the second part where usual care exercise protocol will be introduced.
The manual therapy protocol that will be used is the one proposed by Beltrán-Alacreu et al. (2015). The mentioned protocol consist of specific passive movements in the facet cervical joints, global mobilization of the cervical spine and high-velocity technique in the thoracic región. Receives: Other: Manual Therapy and Usual care exercise protocol for neck pain |
| MT treatment + Augmented reality (AR) exercises | Experimental | The intervention will be divided into two parts, the first one where MT treatment will take place and the second part where AR will be applied as an exercise method.
The same manual therapy protocol will be used for both groups.
For this group, the Microsoft HoloLens Development Edition device will be used, which is a holographic device that allows us to interact with high definition holograms in its environment. The application that will be used will be the Roboraid software, this app is a "shooter", which requires the cervical movement to move the pointer and be able to play. Receives: Other: Manual Therapy and Augmented reality exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI)
A self-completed questionnaire based on Owestry Scale for low back pain. It is one of the most used questionnaires in the evaluation of cervical pain. Evaluates the disability level.
Measured: change measures (Baseline, 4 weeks)
Cervical Joint Position Error Test:
This test is used to assess proprioception at the cervical level and the error in joint position sensation
Measured: change measures (Baseline, 4 weeks)
Resistance test of the neck flexor muscles
To perform this test that will give us the resistance in seconds, the therapist lifts
Measured: change measures (Baseline, 4 weeks)
Secondary outcomes (5)
Tampa Scale for Kinesiophobia(TSK-11)
Self-report that assesses fear related to musculoskeletal pain. It is composed of 11 statements, in which the patient will have to rate from 1 to 4, being 1 totally in disagreement and 4 totally in agreement. The scores will range from 11 to 44 points, the higher the score the greater the fear of pain related to the movement.
Measured: change measures (Baseline, 4 weeks)
Q Sense (Quantitative termal thresholds: cold and heat)
The thermotest Q-sense evaluates quantitatively the termal thresholds such as cold and heat, as well as the sensation of pain due to heat or cold. It provides an comprehensive somatosensory profile. It has been shown that in patients with sensory disorders of different etiologies, the sensory quantitative tests are considered as an useful/valuable diagnostic tool, which have good interobserver and test-retest reliability
Measured: change measures (Baseline, 4 weeks)
Pain (VAS)
is a scale of 100 mm, in which the patient must make a mark to indicate the intensity of its pain, being the minimum value 0, which represents the absence of pain and the maximum value is 10, representing the worst pain.
Measured: change measures (Baseline, 4 weeks)
Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)
This consists of 12 questions, each one of which the participant should circle with a circle the number that best describes his or her degree of satisfaction from 1 to 5 (1 being unsatisfied and 5 very satisfied)
Measured: change measures (Baseline, 4 weeks)
System Usability Scale (SUS)
It consists of 10 questions and the participant should dial the number that best describes their degree of satisfaction from 1 to 5 (1 being unsatisfied and 5 very satisfied)
Measured: change measures (Baseline, 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start22 Apr 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: problems recruiting the sample; derived from pandemic situation COVID-19
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.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Universitario La Salle
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, Hector Beltran-Alacreu, Centro Universitario La Salle
- Investigators
- Josue Fernandez-Carnero, PhD, Study chair, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903380
- Sponsor's protocol ID
- Holo-CNP
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2019
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Therapy and Exercise With Mixed Reality With Hololens® Exercise Protocol in Chronic Neck Pain Subjects: Clinical Trial
- ClinicalTrials.gov ID
- NCT03903380
- Acronym / sponsor ID
- Holo-CNP
- Conditions
- Neck Pain, Chronic Pain
- Keywords
- Virtual reality, Therapeuthic exercise, Quantitative sensory testing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: problems recruiting the sample; derived from pandemic situation COVID-19
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centro Universitario La SalleUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 4 Apr 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.
Currently, cervical pain is the second most frequent musculoskeletal disorder, which generates an important impact on the function and quality of life. It is estimated that its anual prevalence for the general population can reach 50%.
Non-specific cervical pain attends without signs or symptoms of structural or neurological pathology, its etiology is unknown. However, it is related with joint and muscular structures. It has been observed a decrease in the strength and endurace of the deep cervical flexor muscles in 70% of patients with cervical pain; as well as motor control déficit and coordination alterations in the sinergy between the activity of the superficial and deep musculature.
Also, phycosocial factors, as for example: behaviors of fear-avoidance, catastrophism, hypervigilancy, psychosocial stress and negative adaptative neuroplastic changes, may have an importante role in chronic musculoskeletal pain.
In the last years, RV has been used in clinical rehabilitation, being a reliable and valid tool, which allows the patient distration to virtual world and they have offered results like: decreased pain and fear of movement and also improvements in motor performance and neuroplasticity processes.
The aim of this single-blinded randomized novel pilot study is to observe the effects generated in motor variables, when a protocol of manual therapy combined with augmented reality as a method of exercise in subjects with non-specific cervical pain is applied; in comparaison with a protocol of manual therapy combined with conventional cervical exercises.
Different variables will be measured at the beginning and at the end of intervention. Also, they will be measured one month after the intervention to observe the changes produced in short term. These variables are: pain, function, satisfaction, propioception, endurance, as well as phychological and somatosensory variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT treatment + Usual care exercise | Active comparator | Other: Manual Therapy and Usual care exercise protocol for neck painThe intervention will be divided into two parts, the first one where MT treatment will take place and the second part where usual care exercise protocol will be introduced. The manual therapy protocol that will be used is the one proposed by Beltrán-Alacreu et al. (2015). The mentioned protocol consist of specific passive movements in the facet cervical joints, global mobilization of the cervical spine and high-velocity technique in the thoracic región. |
| MT treatment + Augmented reality (AR) exercises | Experimental | Other: Manual Therapy and Augmented reality exercise protocolThe intervention will be divided into two parts, the first one where MT treatment will take place and the second part where AR will be applied as an exercise method. The same manual therapy protocol will be used for both groups. For this group, the Microsoft HoloLens Development Edition device will be used, which is a holographic device that allows us to interact with high definition holograms in its environment. The application that will be used will be the Roboraid software, this app is a "shooter", which requires the cervical movement to move the pointer and be able to play. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Men and women.
- Age: 18-65 years old.
- Persistent neck pain for at least 3 month or intermittent neck pain for 6 month or more.
- 5 points or 10% at the Neck Disability Index questionnaire.
Key exclusion criteria (9 listed)
- Cervical whiplash (10 years before)
- Cervical fractures.
- Vestibular pathology.
- Epilepsy or other neurological condition.
- Systemic diseases.
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 |
|---|---|---|
| Manual Therapy and Usual care exercise protocol for neck painManual Therapy protocol between four to eight sessions and exercise protocol will be progressively added to the intervention (from the fouth session of MT approximately). | Other | MT treatment + Usual care exercise |
| Manual Therapy and Augmented reality exercise protocolManual Therapy protocol between four to eight sessions and Augmented reality exercise protocol will be progressively added to the intervention (from the fouth session of MT approximately). | Other | MT treatment + Augmented reality (AR) exercises |
Primary outcome
Neck Disability Index (NDI)
Time frame: change measures (Baseline, 4 weeks)
A self-completed questionnaire based on Owestry Scale for low back pain. It is one of the most used questionnaires in the evaluation of cervical pain. Evaluates the disability level.
Cervical Joint Position Error Test:
Time frame: change measures (Baseline, 4 weeks)
This test is used to assess proprioception at the cervical level and the error in joint position sensation
Resistance test of the neck flexor muscles
Time frame: change measures (Baseline, 4 weeks)
To perform this test that will give us the resistance in seconds, the therapist lifts
5 secondary outcomes
Tampa Scale for Kinesiophobia(TSK-11)
Time frame: change measures (Baseline, 4 weeks)
Q Sense (Quantitative termal thresholds: cold and heat)
Time frame: change measures (Baseline, 4 weeks)
Pain (VAS)
Time frame: change measures (Baseline, 4 weeks)
Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)
Time frame: change measures (Baseline, 4 weeks)
System Usability Scale (SUS)
Time frame: change measures (Baseline, 4 weeks)
Results and safety
The study was stopped early (reason given: problems recruiting the sample; derived from pandemic situation COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
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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.
Josue Fernandez-Carnero, PhD study chair
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy and Augmented reality exercise protocol in people with Neck Pain and Chronic Pain, run by Centro Universitario La Salle at 1 site in Spain.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Apr 2020. 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 Spain. 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 was stopped early (reason given: problems recruiting the sample; derived from pandemic situation COVID-19). Results are not available in the source record.
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?
Neck Disability Index (NDI) (time frame: change measures (Baseline, 4 weeks)). The study lists 3 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 17 Apr 2020.