Using Mobile Application for Rehabilitation in Patients With Chronic Neck Pain

March 16, 2022 updated by: Mehmet Burak Uyaroğlu, Saglik Bilimleri Universitesi

Evaluation of the Effect of Exercise Program Followed by Mobile Application on Pain, Quality of Life, Functionality and Stability in the Treatment of Patients With Chronic Neck Pain

The aim of this study is to reduce pain, increase range of motion, increase the endurance of deep cervical flexors muscles, and increase quality of life with mobile application in the treatment of patients with chronic neck pain. Although many benefits of exercises have been proven, the effectiveness, follow-up and continuity of exercise will be investigated with mobile application tracking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One of the important factors in mechanical chronic neck pain is the decrease in the endurance of the deep cervical flexor muscles. As a result of this decrease, an increase to the activation of M. Scalenus Anterior and M. Sternocleidomastoid muscles is observed. It is known that patients avoid some movements due to pain, and as a result, loss of muscle strength and endurance in the neck, upper back, around the scapula and shoulder occurs. The loss in strength and endurance, combined with the severity of pain, may affect the stability of the upper extremity has been considered.

Patients with chronic neck pain may experience a number of problems due to the predisposition to accompany pain or some problems caused by neck pain. It is known that all these problems affect the quality of life of patients by limiting their daily living activities.

With the developing technology, mobile health applications have started to be used more and more in our lives. In addition to preventing disease, reducing risk factors, increasing physical activity and quality of life, mobile applications are used in many different areas such as diagnosis, treatment, feedback and monitoring.

Study Type

Interventional

Enrollment (Actual)

62

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

  • Turkey
      • Istanbul, Turkey, 34010
        • Sağlık Bilimleri University

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having chronic neck pain in the past 6 months
  • No communication problem
  • Be Literate,
  • Individuals who speaks Turkish and can use developed mobile application

Exclusion Criteria:

  • Previous neck or shoulder surgery,
  • Shoulder pain due to any reason,
  • Having tumor or inflammatory disease underlying neck pain
  • Having mental disorder,
  • Individual with sequestered disc level or root compression,
  • Individual with uncontrolled diabetes mellitus and hypertension
  • Patients received additional treatment
  • Patients who did not complete physical therapy sessions

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
Active Comparator: Experimental Group
Exercise follow up with mobile application in patients with chronic neck pain five sessions a week for 4 weeks
Other: Exercise follow up with mobile application
Exercises will be followed by mobile application. Electrotherapy will be performed.
Other Names:
  • Exercise with Mobile Application
Procedure: Electrotherapy
Electrotherapy will be performed.
Active Comparator: Control Group
Home based exercise follow up him/herself in patients with chronic neck pain five sessions a week for 4 weeks
Procedure: Electrotherapy
Electrotherapy will be performed.
Other: Home-Based Exercise Program followed by paper booklet
Exercise will be followed by paper booklet. Electrotherapy will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index
Time Frame: Change from pre-interventional Neck Disability Index score at the end of the intervention that will be performed 5 days in a week at a total of 4 weeks.
The Neck Disability Index (NDI) is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation.
Change from pre-interventional Neck Disability Index score at the end of the intervention that will be performed 5 days in a week at a total of 4 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Change from pre-interventional Visual Analog Scale score at the end of the intervention that will be performed 5 days in a week at a total of 4 weeks.
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain).
Change from pre-interventional Visual Analog Scale score at the end of the intervention that will be performed 5 days in a week at a total of 4 weeks.
Assessment of the degree of joint range of motion
Time Frame: Change from pre-interventional Range of Motion Assesment score at the end of the intervention that will be performed 5 days in a week at a total of 4 weeks.
Active range-of-motion(ROM)as measured by a goniometer A ROM assessment is most commonly used to measure movement of the ankles, knees, hips, shoulders, elbows, wrists and fingers. Measures are taken on consecutive occasions to assess any change over time. They are used to determine whether an individual's ROM is within the expected range.
Change from pre-interventional Range of Motion Assesment score at the end of the intervention that will be performed 5 days in a week at a total of 4 weeks.
Manual Muscle Test
Time Frame: Change from pre-interventional Manual Muscle Test Assesment score at the end of the intervention that will be performed 5 days in a week at a total of 4 weeks.

An assessment of muscle strength is typically performed as part of a patient's objective assessment and is an important component of the physical exam.

This test involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly.
Change from pre-interventional Manual Muscle Test Assesment score at the end of the intervention that will be performed 5 days in a week at a total of 4 weeks.
The System Usability Scale (SUS)
Time Frame: Change from pre-interventional System Usability Scale score at the end of the intervention that will be performed 5 days in a week at a total of 4 weeks.
The System Usability Scale (SUS) provides a "quick and dirty", reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications.
Change from pre-interventional System Usability Scale score at the end of the intervention that will be performed 5 days in a week at a total of 4 weeks.

Collaborators and Investigators

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

Sponsor

Saglik Bilimleri Universitesi

Collaborators

Medical Park Hospital Istanbul

Investigators

  • Study Chair: Sümeyye Akçay, PT,MSc, Saglik Bilimleri Universitesi
  • Principal Investigator: Gamze Koyutürk, PT,MSc, Saglik Bilimleri Universitesi
  • Study Chair: Mehmet Burak Uyaroğlu, PT,MSc, Saglik Bilimleri Universitesi
  • Study Chair: Dudu Kübra Akyol, PT, IAU Medical Park Florya Hospital
  • Study Director: Emre Serdar Atalay, Ass. Prof., Saglik Bilimleri Universitesi

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 22, 2021

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

September 22, 2021

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 16, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SaglikBilimU

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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