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

Manual Therapy and Exercise With Mixed Reality With Hololens® Exercise Protocol in Chronic Neck Pain Subjects: Clinical Trial

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03903380
Enrollment
14
Registered
2019-04-04
Start date
2019-04-22
Completion date
2020-04-01
Last updated
2020-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Neck Pain

Keywords

Virtual reality, Therapeuthic exercise, Quantitative sensory testing

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.

Interventions

OTHERManual 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).

OTHERManual 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).

Sponsors

Universidad Rey Juan Carlos
CollaboratorOTHER
Centro Universitario La Salle
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neck Disability Index (NDI)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: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 muscleschange measures (Baseline, 4 weeks)To perform this test that will give us the resistance in seconds, the therapist lifts

Secondary

MeasureTime frameDescription
Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)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)
Tampa Scale for Kinesiophobia(TSK-11)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.
System Usability Scale (SUS)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)
Q Sense (Quantitative termal thresholds: cold and heat)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
Pain (VAS)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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026