NCT05284630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

March 9, 2022

Last Update Submit

March 16, 2022

Conditions

Keywords

Neck PainChronic Painmobile HealthMobile AppsQuality of Life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

Experimental Group

ACTIVE COMPARATOR

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 applicationProcedure: Electrotherapy

Control Group

ACTIVE COMPARATOR

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 bookletProcedure: Electrotherapy

Interventions

Exercises will be followed by mobile application. Electrotherapy will be performed.

Also known as: Exercise with Mobile Application
Experimental Group

Exercise will be followed by paper booklet. Electrotherapy will be performed.

Control Group

Electrotherapy will be performed.

Control GroupExperimental Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglık Bilimleri University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainChronic Pain

Interventions

ExerciseElectric Stimulation Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Sümeyye Akçay, PT,MSc

    Saglik Bilimleri Universitesi

    STUDY CHAIR
  • Gamze Koyutürk, PT,MSc

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR
  • Mehmet Burak Uyaroğlu, PT,MSc

    Saglik Bilimleri Universitesi

    STUDY CHAIR
  • Dudu Kübra Akyol, PT

    IAU Medical Park Florya Hospital

    STUDY CHAIR
  • Emre Serdar Atalay, Ass. Prof.

    Saglik Bilimleri Universitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 17, 2022

Study Start

March 22, 2021

Primary Completion

September 1, 2021

Study Completion

September 22, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations