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Using Mobile Application for Rehabilitation in Patients With Chronic Neck Pain

Primary Purpose

Neck Pain, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise follow up with mobile application
Home-Based Exercise Program followed by paper booklet
Electrotherapy
Sponsored by
Saglik Bilimleri Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Chronic Pain, mobile Health, Mobile Apps, Quality of Life

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saglık Bilimleri University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

Exercise follow up with mobile application in patients with chronic neck pain five sessions a week for 4 weeks

Home based exercise follow up him/herself in patients with chronic neck pain five sessions a week for 4 weeks

Outcomes

Primary Outcome Measures

Neck Disability Index
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

Visual Analog Scale
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain).
Assessment of the degree of joint range of motion
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.
Manual Muscle Test
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.
The System Usability Scale (SUS)
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.

Full Information

First Posted
March 9, 2022
Last Updated
March 16, 2022
Sponsor
Saglik Bilimleri Universitesi
Collaborators
Medical Park Hospital Istanbul
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1. Study Identification

Unique Protocol Identification Number
NCT05284630
Brief Title
Using Mobile Application for Rehabilitation in Patients With Chronic Neck Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saglik Bilimleri Universitesi
Collaborators
Medical Park Hospital Istanbul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Chronic Pain
Keywords
Neck Pain, Chronic Pain, mobile Health, Mobile Apps, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Active Comparator
Arm Description
Exercise follow up with mobile application in patients with chronic neck pain five sessions a week for 4 weeks
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Home based exercise follow up him/herself in patients with chronic neck pain five sessions a week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Exercise follow up with mobile application
Other Intervention Name(s)
Exercise with Mobile Application
Intervention Description
Exercises will be followed by mobile application. Electrotherapy will be performed.
Intervention Type
Other
Intervention Name(s)
Home-Based Exercise Program followed by paper booklet
Intervention Description
Exercise will be followed by paper booklet. Electrotherapy will be performed.
Intervention Type
Procedure
Intervention Name(s)
Electrotherapy
Intervention Description
Electrotherapy will be performed.
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
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.
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.
Secondary Outcome Measure Information:
Title
Visual Analog Scale
Description
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain).
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.
Title
Assessment of the degree of joint range of motion
Description
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.
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.
Title
Manual Muscle Test
Description
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.
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.
Title
The System Usability Scale (SUS)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sümeyye Akçay, PT,MSc
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gamze Koyutürk, PT,MSc
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mehmet Burak Uyaroğlu, PT,MSc
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dudu Kübra Akyol, PT
Organizational Affiliation
IAU Medical Park Florya Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Emre Serdar Atalay, Ass. Prof.
Organizational Affiliation
Saglik Bilimleri Universitesi
Official's Role
Study Director
Facility Information:
Facility Name
Saglık Bilimleri University
City
Istanbul
ZIP/Postal Code
34010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Using Mobile Application for Rehabilitation in Patients With Chronic Neck Pain

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