Clinical trial NCT03903380: Manual Therapy and Exercise With Mixed Reality With Hololens® Exercise Protocol in Chronic Neck Pain Patiens.
Official title: Manual Therapy and Exercise With Mixed Reality With Hololens® Exercise Protocol in Chronic Neck Pain Subjects: Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neck Pain
Chronic Pain
Keywords: Virtual reality
Therapeuthic exercise
Quantitative sensory testing
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2019-04-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: change measures (Baseline, 4 weeks)
measure: Cervical Joint Position Error Test:
timeFrame: change measures (Baseline, 4 weeks)
measure: Resistance test of the neck flexor muscles
timeFrame: change measures (Baseline, 4 weeks)
Secondary outcomes:
measure: Tampa Scale for Kinesiophobia(TSK-11)
timeFrame: change measures (Baseline, 4 weeks)
measure: Q Sense (Quantitative termal thresholds: cold and heat)
timeFrame: change measures (Baseline, 4 weeks)
measure: Pain (VAS)
timeFrame: change measures (Baseline, 4 weeks)
measure: Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)
timeFrame: change measures (Baseline, 4 weeks)
measure: System Usability Scale (SUS)
timeFrame: change measures (Baseline, 4 weeks)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IRF La Salle
state: Comunidad De Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josue Fernandez-Carnero, PhD
role: STUDY_CHAIR
References: