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

Primary Purpose

Neck Pain, Chronic Pain

Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy and Usual care exercise protocol for neck pain
Manual Therapy and Augmented reality exercise protocol
Sponsored by
Centro Universitario La Salle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Virtual reality, Therapeuthic exercise, Quantitative sensory testing

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRF La Salle

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

MT treatment + Usual care exercise

MT treatment + Augmented reality (AR) exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Cervical Joint Position Error Test:
This test is used to assess proprioception at the cervical level and the error in joint position sensation
Resistance test of the neck flexor muscles
To perform this test that will give us the resistance in seconds, the therapist lifts

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2019
Last Updated
April 15, 2020
Sponsor
Centro Universitario La Salle
Collaborators
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT03903380
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
problems recruiting the sample; derived from pandemic situation COVID-19
Study Start Date
April 22, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario La Salle
Collaborators
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Chronic Pain
Keywords
Virtual reality, Therapeuthic exercise, Quantitative sensory testing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT treatment + Usual care exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MT treatment + Augmented reality (AR) exercises
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Manual Therapy and Usual care exercise protocol for neck pain
Intervention Description
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
Intervention Name(s)
Manual Therapy and Augmented reality exercise protocol
Intervention Description
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 Measure Information:
Title
Neck Disability Index (NDI)
Description
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.
Time Frame
change measures (Baseline, 4 weeks)
Title
Cervical Joint Position Error Test:
Description
This test is used to assess proprioception at the cervical level and the error in joint position sensation
Time Frame
change measures (Baseline, 4 weeks)
Title
Resistance test of the neck flexor muscles
Description
To perform this test that will give us the resistance in seconds, the therapist lifts
Time Frame
change measures (Baseline, 4 weeks)
Secondary Outcome Measure Information:
Title
Tampa Scale for Kinesiophobia(TSK-11)
Description
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.
Time Frame
change measures (Baseline, 4 weeks)
Title
Q Sense (Quantitative termal thresholds: cold and heat)
Description
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
Time Frame
change measures (Baseline, 4 weeks)
Title
Pain (VAS)
Description
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.
Time Frame
change measures (Baseline, 4 weeks)
Title
Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)
Description
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)
Time Frame
change measures (Baseline, 4 weeks)
Title
System Usability Scale (SUS)
Description
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)
Time Frame
change measures (Baseline, 4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josue Fernandez-Carnero, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Chair
Facility Information:
Facility Name
IRF La Salle
City
Madrid
State/Province
Comunidad De Madrid
ZIP/Postal Code
28023
Country
Spain

12. IPD Sharing Statement

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

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