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

NCT05593289 | Unknown DMC

• 1 other identifier: R-2022-3511-021
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Sprain; Neck Pain

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (1)

• 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

Study Arms (2)

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.

Other: telerehabilitation

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.

Interventions

telerehabilitation 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.

Telerehabilitation group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (2)

Unidad de Medicina Familiar 21

Iztacalco, Mexico City, 08300, Mexico

RECRUITING

Unidad de Medicina Familiar 21

Mexico City, 08300, Mexico

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Neck Pain

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Juan Figueroa, MSc

  Juan Figueroa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Figueroa, MSc

CONTACT

5526531330; figueroagj@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 25, 2022
• Study Start: November 21, 2022
• Primary Completion: November 17, 2023
• Study Completion: November 24, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)