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临床试验/NCT05593289
NCT05593289Unknown不适用

Effectiveness of the Neck-Specific Exercise Program Through TeleRehabilitation Compared to the Usual Intervention in Functional Recovery in Adults With Acute Cervical Sprain Grade I and II in the First Level of Care

Instituto Mexicano del Seguro Social2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年11月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
68
试验地点
2
主要终点
Changes in neck functionality, from baseline and at weeks 2, 6 and 12

研究概览

简要总结

Cervical sprain also known as whiplash-associated disorder is the result of a combined injury between extension/flexion of the soft tissues of the cervical spine due to an acceleration-deceleration mechanism of energy transfer to the neck. The Neck-Specific Exercise Program focuses on relearning motor skills, neck muscle endurance, and postural correction. Telehealth improves patient satisfaction, overcomes barriers to access to physiotherapy services and reduces the costs of musculoskeletal care.

Objective: To evaluate the effectiveness of the neck specific exercise program by telerehabilitation compared to the usual intervention in functional recovery in adults with acute cervical sprain grade I and II at the first level of care.

Material and Methods: This is a randomized clinical trial, the effectiveness of the telerehabilitation program is determined by the Neck Disability Index (NDI) and will be compared against the usual intervention. Participants assigned to the telerehabilitation program will complete a 12-week intervention consisting of 5 weekly sessions of 30 minutes of pre-recorded video, with a frequency of 2-3 times a day. The usual care group will be instructed to follow their doctors' orders during the 12-week intervention period. For each group, baseline measurements were made at 2, 6 and 12 weeks.

Time to develop: The protocol has a duration of follow-up of the patients of 12 weeks.

详细描述

The neck-related musculoskeletal disorders (MSDs), whether attributed to work, injury, or other activities manifest neck pain, are a prevalent source of disability and a common reason for consulting primary health care providers, including physical therapists and primary care physicians. Neck pain related to disorders associated with cervical sprain is the most common result of car accidents. Associated cervical sprain disorders disrupt the daily lives of adults worldwide and are associated with considerable pain, suffering, disability and costs. Cervical sprain (CD), also known as whiplash-associated disorder, is the result of a combined extension/flexion injury of the soft tissues of the cervical spine due to an acceleration-deceleration mechanism of energy transfer to the neck. The Quebec Task Force Classification System, is the classification that determine the degree of injury. This classification is based solely on clinical signs, dividing them into 5 categories: 0. Asymptomatic, 1. Cervical pain, muscle spasm, no physical signs, 2. Stiffness, localized pain, 3. Symptoms, signs and neurological clinic and 4. Bone injury, fracture/dislocation.

The objective of treatment should be aimed at restoring the functionality of the individual with a biopsychosocial approach, so that structured patient education should be considered, making patients aware of the typical course and treatment of grade I-II CD, the importance of maintaining life activities and movement, to actively participate in your care plan by remaining active and maintaining neck movement, emphasizing active treatments instead of passive treatments. The main objective is to reincorporate the patient into daily life activities. Functionality is defined as: "the ability of the person to autonomously perform the activities of daily living." The loss of functionality in CD is associated with chronic pain, limitation in the arcs of movement, it is also an indicator of mental health. The effects of telerehabilitation, when associated with usual care or as an independent intervention, have also been evaluated in chronic non-malignant musculoskeletal pain. The use of telerehabilitation as a tool for conducting MSD assessments has been investigated, specifically in adults with non-specific neck pain compared to conventional methods, finding validity and reliability, thus adding more evidence to the existing evaluation based on telerehabilitation for MSDs.

Problem statement: In Mexico, the Mexican Institute of Social Security provides care for this type of condition, however in the Family Medicine Units (primary health) there are no physiotherapists who evaluate and manage the cervical sprain early which has been demonstrated, has an impact on the functional recovery time of patients with muscle injuries, the above is important since it has been shown that early rehabilitation is one of the most effective strategies for functional recovery in musculoskeletal disorders.

Research question: What is the effectiveness of the Neck-Specific Exercise Program by telerehabilitation compared to the usual intervention in functional recovery in adults with grade I and II acute cervical sprain at the first level of care?

Hypothesis: The effectiveness of the Neck-Specific Exercise Program in functional recovery in adults with grade I and II acute cervical sprain who performed the neck-specific exercise program using telerehabilitation for 6 weeks is that they will improve at least 3.5 points or more in levels of functionality through the Neck Disability Index (NDI) compared to those who performed the usual intervention.

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 (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Eligible patients of the Mexican Social Security Institute of both sexes between 18-60 years old.
  • •That they are diagnosed with grade I or II acute cervical sprain for the first time Agree to participate in the study and sign the informed consent.
  • •That they are users of smartphone and / or computer with internet connection.
  • •Have the approval of the attending physician.

排除标准

  • •Not knowing how to read or write.
  • •Patients with neurological conditions.
  • •Loss of alertness or memory during the event that generated the cervical sprain.
  • •History of cervical disc herniations, nerve compressions with cervical irradiation, myelopathy, cervical surgeries, fibromyalgia.
  • •Allergy to latex.
  • •Patients whose work activity is considered by the attending physician as very heavy.
  • •Elimination Criteria:
  • •Failure to complete the evaluation instrument in its entirety
  • •Failure to complete the telerehabilitation program

研究组 & 干预措施

Telerehabilitation group

Experimental

Participants assigned to the telerehabilitation program will complete a 3 month intervention consisting of 5 weekly sessions of 30 minutes of pre-recorded video, with a frequency of 2-3 times a day.

干预措施: telerehabilitation (Other)

Control group

No Intervention

The usual care group will be instructed to follow their physicians' orders during the 3-month intervention period. Baseline measurements will be made for each group, at 2 weeks, 6 weeks and 3rd month.

结局指标

主要结局

Changes in neck functionality, from baseline and at weeks 2, 6 and 12

时间窗: A baseline measurement at study entry, then three more follow-up assessments at week 2, week 6, and 12 weeks

Ability of the person in his neck to perform activities of daily living, which will be measured with the Neck Disability Index (NDI), which scores from 0 to 50 points, where 0 is poor neck functionality and 50 is better functionality.

次要结局

  • Changes in neck pain, from baseline and at weeks 2, 6 and 12(A baseline measurement at study entry, then three more follow-up assessments at week 2, week 6, and 12 weeks)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Juan Figueroa-García

Principal investigator

Instituto Mexicano del Seguro Social

研究点 (2)

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