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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05284630
Other study ID # SaglikBilimU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 22, 2021
Est. completion date September 22, 2021

Study information

Verified date March 2022
Source Saglik Bilimleri Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date September 22, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise follow up with mobile application
Exercises will be followed by mobile application. Electrotherapy will be performed.
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.

Locations

Country Name City State
Turkey Saglik Bilimleri University Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Medical Park Hospital Istanbul

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 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). 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.
Secondary 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. 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.
Secondary 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.
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.
Secondary 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. 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.
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