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Manual Therapy and Exercise With Mixed Reality With Hololens® Exercise Protocol in Chronic Neck Pain Patiens.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903380
Recruitment Status : Terminated (problems recruiting the sample; derived from pandemic situation COVID-19)
First Posted : April 4, 2019
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
Universidad Rey Juan Carlos
Information provided by (Responsible Party):
Hector Beltran-Alacreu, Centro Universitario La Salle

Brief 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%.

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.


Condition or disease Intervention/treatment Phase
Neck Pain Chronic Pain Other: Manual Therapy and Usual care exercise protocol for neck pain Other: Manual Therapy and Augmented reality exercise protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manual Therapy and Exercise With Mixed Reality With Hololens® Exercise Protocol in Chronic Neck Pain Subjects: Clinical Trial
Actual Study Start Date : April 22, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MT treatment + Usual care exercise

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.

Other: Manual Therapy and Usual care exercise protocol for neck pain
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).

Experimental: MT treatment + Augmented reality (AR) exercises

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.

Other: Manual Therapy and Augmented reality exercise protocol
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).




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Tampa Scale for Kinesiophobia(TSK-11) [ Time Frame: change measures (Baseline, 4 weeks) ]
    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.

  2. Q Sense (Quantitative termal thresholds: cold and heat) [ Time Frame: change measures (Baseline, 4 weeks) ]
    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

  3. Pain (VAS) [ Time Frame: change measures (Baseline, 4 weeks) ]
    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.

  4. Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0) [ Time Frame: change measures (Baseline, 4 weeks) ]
    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)

  5. System Usability Scale (SUS) [ Time Frame: change measures (Baseline, 4 weeks) ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • Cervical whiplash (10 years before)
  • Cervical fractures.
  • Vestibular pathology.
  • Epilepsy or other neurological condition.
  • Systemic diseases.
  • Cardiovascular or respiratory disorders that affect physical performance.
  • Lasik eye surgery.
  • Fibromyalgia
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903380


Locations
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Spain
IRF La Salle
Madrid, Comunidad De Madrid, Spain, 28023
Sponsors and Collaborators
Centro Universitario La Salle
Universidad Rey Juan Carlos
Investigators
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Study Chair: Josue Fernandez-Carnero, PhD Rey Juan Carlos University
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Responsible Party: Hector Beltran-Alacreu, Principal Investigator, Centro Universitario La Salle
ClinicalTrials.gov Identifier: NCT03903380    
Other Study ID Numbers: Holo-CNP
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hector Beltran-Alacreu, Centro Universitario La Salle:
Virtual reality
Therapeuthic exercise
Quantitative sensory testing
Additional relevant MeSH terms:
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Chronic Pain
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms