Effectiveness of a Telerehabilitation Program in Acute Cervical Sprain Grade I and II

NCT ID: NCT05593289

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2023-11-24

Brief Summary

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.

Detailed Description

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.

Objective: To assess the effectiveness of the Neck-Specific Exercise Program though telerehabilitation compared with the usual intervention in functional recovery in adults with grade I and II acute cervical sprain at the first level of care.

Material and Methods Studio Design: This is a randomized clinical trial, in which the effectiveness of the telerehabilitation program is determined by the functionality indicator using the Neck Disability Index and will be compared against the usual intervention. Randomization will be carried out through the generation of random numbers in the Office Excel program by blocks of 5, to assignment to the experimental treatment and control will be carried out through opaque envelopes according to the distribution generated by computer, at the time of assignment to the treatment the researcher will not have any bias in assigning one or another treatment. The recruitment of participants, the assignment of participants to interventions and evaluations will be carried out by independent evaluators. Blinding of participants and staff in charge of teaching the telerehabilitation program as well as the usual intervention will not be possible due to the nature of the intervention. Evaluators will be blinded to group assignment as it will be other evaluators who assign participants to groups and conduct follow-up evaluations. 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. The usual care group will be instructed to follow your doctors' orders during the 3-month intervention period. For each group, baseline measurements will be made, at 2 weeks, 6 weeks and 12 weeks.

Sample Size: For the calculation of the sample size, it was based on the formula of the sample of an average. Considered a statistically significant difference in the Neck Disability Index to measure neck functionality, having a result of 3.5 (standard deviation 6.3), with a significance level of 0.05 and a power of 80%, an estimated loss of 20% is considered, a sample size of 28 subjects is estimated, plus the estimated loss a final sample of 34 subjects. Explicative variables: Specific Neck Exercise Program (NSE) through planned telerehabilitation physical activity. Outcome variables: Functional capacity of the neck, it will be obtained through the Neck Disability Index (NDI) and pain, it will be obtained through the Visual Analogue Scale.

Recruitment and Data Collection Process: Patients who present a first-time diagnosis of grade I and II cervical sprain will be selected from the consultation of the Family Medicine Unit number 33. Potential participants will be identified through a 5-step process, this process includes: 1. The study will be invited by direct invitation by the attending physician as well as posters placed in the offices and advertising areas within the clinic, once there is interest on the part of the patients, in a space specifically designated for the approach of the participants. 2. It will be make a check of medical records in case there is uncertainty or any missing data regarding the medical history. 3. Participants will be selected to determine their eligibility using the selection criteria. 4. It will perform a clinical physical examination performed by an experienced physician or physical therapist to classify the disorder as a grade I or II. 5.The participants will be given the NDI questionnaire for self-assessment.

Intervention neck-specific exercise program: All participants will receive verbal and written information about the study, once they accept and sign the informed concentration, they will be taught the use of the telerehabilitation program (which consists of written, graphic and video information on the digital platform, which is a teaching system designed to create and manage adapted online learning spaces) that they must make, as well as written information of the program, once they finish the teaching activity of the platform, emphasis will be placed on doubts about the use of the platform, in case of having any doubt, it will be resolved at that time. The telerehabilitation program is designed on a weekly basis, which will be explained to the participant the way in which they must do it. Once the teaching activity of use of the platform is finished, a resistance link will be given to the patient to be able to carry out a part of the protocol and will be followed up through it, since, through digital platform, you can know the time spent interacting with it; the time of the telerehabilitation activities will be 30 minutes daily.

The telerehabilitation program of Neck-Specific Exercise (NSE) is divided into 3 stages with a final duration of 12 weeks. The first stage consists of a series of three exercises, which will be performed isometric contractions maintained of five seconds with a rest between them of five seconds, which will be distributed in three series of five repetitions. It aims to facilitate deep muscle activity of the neck, without superficial muscle activity. The second stage consists of a series of three exercises, which will be performed resisted isometric contractions of five seconds of contraction with a rest between them of five seconds, which will be distributed in three series of 10 repetitions. The third stage consists of a series of five exercises, which will perform concentric contractions of progressive resistance, which will be distributed in three series of 20 repetitions. An initial face-to-face evaluation will be carried out (at study entry) and follow-up will be given for 12 weeks (by telephone at weeks 2, 6 and 12 after entering the study). Usual intervention: In the usual intervention the patient will be provided with the usual exercise program which contains a series of exercises that are routinely used to address this pathology, which must be performed three times a day, 10 times each, as well as an explanation of them and will be sent home for completion.

Descriptive statistics: The qualitative variables will be summarized in absolute and relative frequencies and the quantitative variables in measures of central tendency and dispersion, if they meet the criterion of normality by means of the Kolmogorov-Smirnov test will be used mean and standard deviation in case of not fulfilling the assumption will be used median and quartile 1 and 3. Inferential statistics: For the comparison of the dependent variables in the telerehabilitation group, before and at the end of the study student's t will be used for related samples , if they do not meet the normality criterion, the Wilcoxon test will be used. In order to identify possible confounding variables, the clinical and demographic characteristics will be compared, to compare the quantitative variables, student's t will be used and McNemar's Chi square will be used to compare the qualitative variables. A value of p< 0.05 shall be considered statistically significant. All analyses will be performed using the statistical program Stata version 14.

Ethical Considerations: The present protocol that will be carried out in the adult population with acute cervical sprain grade I and II, this adheres to the guidelines of the Declaration of Helsinki and those of the Mexican General law of health in force about research in human beings. Confidentiality: The data provided in this study are totally confidential, their results will be used globally and for statistical purposes.

Conditions

Neck Sprain; Neck Pain

Study Design

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

Study Groups

Telerehabilitation group

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.

Group Type: EXPERIMENTAL

telerehabilitation

Intervention Type: OTHER

Physical activity that is planned, structured with repeated muscle movements with the aim of relearning motor skills, resistance of neck muscles and postural correction.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

telerehabilitation

Physical activity that is planned, structured with repeated muscle movements with the aim of relearning motor skills, resistance of neck muscles and postural correction.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: lead

Responsible Party

Juan Figueroa-García

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juan Figueroa, MSc

Role: PRINCIPAL_INVESTIGATOR

Juan Figueroa

Locations

Unidad de Medicina Familiar 21

Iztacalco, Mexico City, Mexico

Site Status: RECRUITING

Unidad de Medicina Familiar 21

Mexico City, , Mexico

Site Status: RECRUITING

Countries

Mexico

Central Contacts

Juan Figueroa, MSc

Role: CONTACT

figueroagj@hotmail.com

5526531330

Facility Contacts

Juan Figueroa, MSc

Role: primary

figueroagj@hotmail.com

011+52+5526531330

Juan Figueroa, MSc

Role: primary

figueroagj@hotmail.com

5526531330

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Other Identifiers

R-2022-3511-021

Identifier Type: -

Identifier Source: org_study_id