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

NCT ID: NCT03903380

Last Updated: 2020-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-22
• Study Completion Date: 2020-04-01

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.

Conditions

Neck Pain; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Manual Therapy and Usual care exercise protocol for neck pain

Intervention Type: OTHER

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).

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.

Group Type: EXPERIMENTAL

Manual Therapy and Augmented reality exercise protocol

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: collaborator

Centro Universitario La Salle

OTHER

Sponsor Role: lead

Responsible Party

Hector Beltran-Alacreu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josue Fernandez-Carnero, PhD

Role: STUDY_CHAIR

Universidad Rey Juan Carlos

Locations

IRF La Salle

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

Holo-CNP

Identifier Type: -

Identifier Source: org_study_id