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

NCT03903380 | Terminated

• 1 other identifier: Holo-CNP
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

Virtual reality; Therapeuthic exercise; Quantitative sensory testing

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  change measures (Baseline, 4 weeks)

Secondary Outcomes (5)

• Tampa Scale for Kinesiophobia(TSK-11)

  change measures (Baseline, 4 weeks)

• Q Sense (Quantitative termal thresholds: cold and heat)

  change measures (Baseline, 4 weeks)

• Pain (VAS)

  change measures (Baseline, 4 weeks)

• Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)

  change measures (Baseline, 4 weeks)

• System Usability Scale (SUS)

  change measures (Baseline, 4 weeks)

Study Arms (2)

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.

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.

Other: Manual Therapy and Augmented reality exercise protocol

Interventions

Manual Therapy and Usual care exercise protocol for neck pain 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 + Usual care exercise

Manual Therapy and Augmented reality exercise protocol 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).

MT treatment + Augmented reality (AR) exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• points or 10% at the Neck Disability Index questionnaire.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Universitario La Salle: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

IRF La Salle

Madrid, Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Neck Pain; Chronic Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Josue Fernandez-Carnero, PhD

  Universidad Rey Juan Carlos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 4, 2019
• Study Start: April 22, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

ES (1)