The Effect of Telerehabilitation in Patients With Chronic Neck Pain

August 12, 2022 updated by: Fatih ÖZDEN, Marmara University

The Effect of Telerehabilitation and Conventional Rehabilitation on Clinical Results and Exercise Adherence in Patients With Chronic Neck Pain

Telerehabilitation offers more efficient follow-up of patients during their home exercise period as a cost-effective and effective treatment model. This study was planned to examine the effectiveness of telerehabilitation in patients with chronic neck pain. The aim of the study is to compare the video-based and telerehabilitation based home-exercise program in patients with chronic neck pain. It is aimed to evaluate the patients in terms of pain, functionality, quality of life, and exercise adherence.

Study Overview

Detailed Description

With telerehabilitation, patients can easily adapt to home exercise programs and be monitored remotely. In this way, it will be ensured that individuals can apply their exercises at an optimum level in non-clinical settings and to prevent exercise application errors that occur due to the learning effect frequently observed in conventional methods. Exercise is considered a central element in physical therapy and rehabilitation management in patients with chronic neck pain. However, studies have found that improvements after physical therapy and rehabilitation are not preserved in the long term, and recurrence of chronic low back pain is common. With a more cost-effective treatment model, "telerehabilitation", it is aimed that patients can be followed more efficiently during their home exercise period. The aim of the study is to compare the video-based and telerehabilitation based home-exercise program in patients with chronic neck pain. It is aimed to evaluate the patients in terms of pain, functionality, quality of life, and exercise adherence.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Muğla, Turkey
        • Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between the ages of 18 - 65
  • Patients who have suffered from neck pain for at least 3 months
  • Signing the consent form

Exclusion Criteria:

  • Situations that prevent the evaluation or communication with the individual
  • Illiterate individuals
  • Individuals who have undergone an operation due to neck pain problem, diagnosed with a tumor, infection, ankylosing spondylitis, rheumatoid arthritis or inflammatory diseases, fracture, cauda equina syndrome
  • Conditions in which specific pathological condition is proven such as malignant condition, fracture, systemic rheumatoid disease
  • Orthopedic and neurological problems that prevent evaluation and/or treatment
  • Complaints of pain and numbness spreading to the upper extremities
  • Individuals with a diagnosed psychiatric disease
  • Individuals who have received physiotherapy in the last 6 months
  • Individuals using another treatment method during the study
  • Individuals with musculoskeletal pain in any other part of the body during work
  • Pregnant participants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation (TR) Group
The TR group will be followed up through the video-based exercise software within the 8-week home exercise program.
The home exercise program will be educated to the patient on the first day. Exercises for isometric and isotonic strengthening, stretching, and stabilization of the neck muscles will be given. Exercises will be presented to the patients in audio-video format and detailed instructions with explanations. The exercise protocol will also be the same as in the conventional rehabilitation group. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.
Active Comparator: Conventional Rehabilitation (CR) Group
The CR group will be trained face-to-face with conventional methods before the 8-week home exercise program, and an exercise program will be prescribed with a visual information form.
The home exercise program will be educated to the patient on the first day. Isometric and isotonic strengthening, stretching and stabilization exercises for the neck muscles will be given. Exercise information form including explanation and picture of the exercises will be given to the patients. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form-36 (SF-36)
Time Frame: 5 minutes
SF-36 consists of thirty-six items. These provide measurements of eight dimensions. Subscales evaluate health between 0-100 points; '0' indicates poor health, '100' indicates good health.
5 minutes
Visual Analogue Scale (VAS)
Time Frame: 2 minutes

The patients will be asked to mark their pain feelings for rest and activity on a 10 cm numerical line (0: no pain, 10: unbearable pain). It is planned to use numerical VAS in our study. The cut-off values for chronic musculoskeletal pain will be classified as the severity of pain according to VAS as follows:

<3.4 centimeters: mild pain, 3.5-7.4 centimeters: moderate pain, > 7.5 centimeters: severe pain.

2 minutes
Neck Disability Index (NDI)
Time Frame: 5 minutes
NDI consists of 10 titles: pain intensity, personal care, lifting, reading, headache, concentration, study, driving, sleeping, and recreation. For each item included in the study; 0 indicates "no disability" and 5 represents "complete disability" Participants will be asked to give points between these scores. The total score ranges between 0 (no disability) and 50 (complete disability).
5 minutes
Tampa Scale for Kinesiophobia
Time Frame: 5 minutes
The scale is a 17-item. A 4-point Likert scoring (1= strongly disagree, 4= totally agree) is used in the scale. The participant gets a total score between 17-68. The high score obtained by the participant indicates that the kinesiophobia is also high.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Adherence Rating Scale (EARS)
Time Frame: 5 minutes
EARS provides a measurement of commitment to home exercise. This may facilitate the evaluation of interventions that promote self-management, for the treatment of chronic conditions.
5 minutes
Telemedicine Patient Questionnaire
Time Frame: 5 minutes
Telemedicine Patient Questionnaire evaluates the usability and satisfaction of the patients. The total score is scored between 17 and 85. Higher scores indicate expectation, satisfaction and usability.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mehmet Özkeskin, PhD, Ege University
  • Principal Investigator: İsmet Tümtürk, MSc, Ege University
  • Principal Investigator: Cem Yalın Kılınç, Muğla Sıtkı Koçman University
  • Study Chair: Fatih Özden, Muğla Sıtkı Koçman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2022

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

July 29, 2022

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2022

Last Update Submitted That Met QC Criteria

August 12, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mugla Training and Research

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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