Using Mobile Application for Rehabilitation in Patients With Chronic Neck Pain

Sponsor
Saglik Bilimleri Universitesi (Other)
Overall Status
Completed
CT.gov ID
NCT05284630
Collaborator
Medical Park Hospital Istanbul (Other)
62
1
2
6
10.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise follow up with mobile application
  • Other: Home-Based Exercise Program followed by paper booklet
  • Procedure: Electrotherapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 22, 2021
Actual Primary Completion Date :
Sep 1, 2021
Actual Study Completion Date :
Sep 22, 2021

Arms and Interventions

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

    Other: Home-Based Exercise Program followed by paper booklet
    Exercise will be followed by paper booklet. Electrotherapy will be performed.

    Procedure: Electrotherapy
    Electrotherapy will be performed.

    Outcome Measures

    Primary Outcome Measures

    1. Neck Disability Index [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.

    Secondary Outcome Measures

    1. Visual Analog Scale [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).

    2. Assessment of the degree of joint range of motion [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.

    3. Manual Muscle Test [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.

    4. The System Usability Scale (SUS) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saglık Bilimleri University Istanbul Turkey 34010

    Sponsors and Collaborators

    • Saglik Bilimleri Universitesi
    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mehmet Burak Uyaroğlu, Principal Investigator, Saglik Bilimleri Universitesi
    ClinicalTrials.gov Identifier:
    NCT05284630
    Other Study ID Numbers:
    • SaglikBilimU
    First Posted:
    Mar 17, 2022
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mehmet Burak Uyaroğlu, Principal Investigator, Saglik Bilimleri Universitesi
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022