Neck PainNCT05284630
Using Mobile Application for Rehabilitation in Patients With Chronic Neck Pain
A study testing Exercise follow up with mobile application, Home-Based Exercise Program followed by paper booklet and Electrotherapy in people with Neck Pain and Chronic Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Neck Pain, Chronic Pain
- What is being tested?
- Exercise follow up with mobile application, Home-Based Exercise Program followed by paper booklet and Electrotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Mar 2021to 22 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having chronic neck pain in the past 6 months
- No communication problem
- Be Literate,
- Individuals who speaks Turkish and can use developed mobile application
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Neck Pain, Chronic Pain
- Being tested
- Exercise follow up with mobile application, Home-Based Exercise Program followed by paper booklet, Electrotherapy
- Keywords
- Neck Pain, Chronic Pain, mobile Health, Mobile Apps, Quality of Life
- Medical subject headings
- Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise follow up with mobile applicationOther
Also called Exercise with Mobile Application
Exercises will be followed by mobile application. Electrotherapy will be performed.
Home-Based Exercise Program followed by paper bookletOther
Exercise will be followed by paper booklet. Electrotherapy will be performed.
ElectrotherapyProcedure or surgery
Electrotherapy will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Active comparator | Exercise follow up with mobile application in patients with chronic neck pain five sessions a week for 4 weeks Receives: Other: Exercise follow up with mobile application; Procedure: 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 Receives: Other: Home-Based Exercise Program followed by paper booklet; Procedure: Electrotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain).
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start22 Mar 2021
- Primary completion1 Sep 2021
- Study completion22 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Park Hospital Istanbul
- Responsible party
- Principal investigator, Mehmet Burak Uyaroğlu, Saglik Bilimleri Universitesi
- Investigators
- Sümeyye Akçay, PT,MSc, Study chair, Saglik Bilimleri UniversitesiGamze Koyutürk, PT,MSc, Principal investigator, Saglik Bilimleri UniversitesiMehmet Burak Uyaroğlu, PT,MSc, Study chair, Saglik Bilimleri UniversitesiDudu Kübra Akyol, PT, Study chair, IAU Medical Park Florya HospitalEmre Serdar Atalay, Ass. Prof., Study director, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284630
- Sponsor's protocol ID
- SaglikBilimU
- Status last verified
- Mar 2022
- First submitted
- 9 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05284630
- Acronym / sponsor ID
- SaglikBilimU
- Conditions
- Neck Pain, Chronic Pain
- Keywords
- Neck Pain, Chronic Pain, mobile Health, Mobile Apps, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Medical Park Hospital Istanbul
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Active comparator | Other: Exercise follow up with mobile application, Procedure: ElectrotherapyExercise follow up with mobile application in patients with chronic neck pain five sessions a week for 4 weeks |
| Control Group | Active comparator | Other: Home-Based Exercise Program followed by paper booklet, Procedure: ElectrotherapyHome based exercise follow up him/herself in patients with chronic neck pain five sessions a week for 4 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having chronic neck pain in the past 6 months
- No communication problem
- Be Literate,
- Individuals who speaks Turkish and can use developed mobile application
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise follow up with mobile applicationAlso: Exercise with Mobile ApplicationExercises will be followed by mobile application. Electrotherapy will be performed. | Other | Experimental Group |
| Home-Based Exercise Program followed by paper bookletExercise will be followed by paper booklet. Electrotherapy will be performed. | Other | Control Group |
| ElectrotherapyElectrotherapy will be performed. | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
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Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
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Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sümeyye Akçay, PT,MSc study chair
Saglik Bilimleri Universitesi
Gamze Koyutürk, PT,MSc principal investigator
Saglik Bilimleri Universitesi
Mehmet Burak Uyaroğlu, PT,MSc study chair
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise follow up with mobile application, Home-Based Exercise Program followed by paper booklet and Electrotherapy in people with Neck Pain and Chronic Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.