跳至主要内容
临床试验/NCT03903380
NCT03903380终止不适用

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

Centro Universitario La Salle2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年4月22日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
14
试验地点
2
主要终点
Neck Disability Index (NDI)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - 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.

排除标准

  • 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

结局指标

主要结局

Neck Disability Index (NDI)

时间窗: 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:

时间窗: 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 muscles

时间窗: change measures (Baseline, 4 weeks)

To perform this test that will give us the resistance in seconds, the therapist lifts

次要结局

  • Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)(change measures (Baseline, 4 weeks))
  • Tampa Scale for Kinesiophobia(TSK-11)(change measures (Baseline, 4 weeks))
  • System Usability Scale (SUS)(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))

研究者

发起方
Centro Universitario La Salle
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hector Beltran-Alacreu

Principal Investigator

Centro Universitario La Salle

研究点 (2)

Loading locations...

相似试验