Smartphone Addiction, Temporomandibular Joint DysfunctionNCT05331989
Smartphone Addiction and Temporomandibular Joint Dysfunction in Individuals With Nonspecific Neck Pain
An observational study of Smartphone Addiction, Temporomandibular Joint Dysfunction, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
It has been reported that excessive use of smartphones increases the stress on the cervical spine, and changes in cervical curvature and pain in the muscles around the neck are associated with the increase in stress. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Smartphone Addiction, Temporomandibular Joint Dysfunction
- What is being tested?
- patient group/ healthy group
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2022to 1 Apr 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: Individuals with nonspecific neck pain, individuals who voluntarily agreed to participate in our study and signed the consent form
Who may be able to join
- Presence of neck pain lasting at least 6 months
- Being between the ages of 18-45
- Individuals with a score between 10-40 points according to the Neck Disability Index
- Individuals who have never had a history of shoulder or neck surgery
Who cannot join
- Individuals with signs of radicular pain (positive neck distraction test, Spurling's neck compression test, and Adson's test)
- Individuals who get less than 10 points or more than 40 points according to the Neck Disability Index
- Those with a previous history of shoulder and neck surgery
- Individuals with accompanying shoulder pain
- Individuals with spinal cord tumors
- Individuals with meningeal tumors
- Individuals who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
It has been reported that excessive use of smartphones increases the stress on the cervical spine, and changes in cervical curvature and pain in the muscles around the neck are associated with the increase in stress. Studies have reported that smartphone users with addictions have neck pain (68%), upper back pain (62%), right shoulder pain (52%), left shoulder pain (46%), and right hand pain (46%). As a result of our study, the frequency of smartphone addiction and temporomandibular joint dysfunction and related factors in individuals with nonspecific neck pain were examined and the results we obtained will contribute to the literature.
- Being tested
- patient group/ healthy group
- Medical subject headings
- Internet Addiction Disorder, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient group/ healthy groupOther
Cranio- Cervical Flexion Test, cervical mobility, Pressure Pain Threshold,Functional evaluation of the temporomandibular joint,Pittsburg Sleep Quality Index
| Study group | Role | What they receive |
|---|---|---|
| patient group,healthy group | Cranio- Cervical Flexion Test, cervical mobility, Pressure Pain Threshold,Functional evaluation of the temporomandibular joint,Pittsburg Sleep Quality Index Receives: Other: patient group/ healthy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cranio- Cervical Flexion Test
An inflatable pressure unit (StabilizerTM, Chattanooga Group, Inc., Hixson, TN) will be used during testing.
Measured: Day 1
Evaluation of cervical mobility
Cervical region flexion, extension, lateral flexion and rotation movements will be evaluated with Baseline Bubble Inclinometer.
Measured: Day 1
Evaluation of Pressure Pain Threshold
Pressure pain threshold assessment will be performed with an algometer, which is an objective assessment method.Measurements will be made from three different regions: anterior temporal muscle body, masseter muscle body and TMJ (lateral to the mandibular condyle).
Measured: Day 1
Functional evaluation of the temporomandibular joint
The Helkimo Clinic Craniomandibular Index will be used in the evaluation of TMJ (5). This index consists of 5 subsections: pain on muscle palpation, pain on TMJ palpation, pain on mandible functions, TMJ functions (sound, gliding at maximum opening, luxation and/or locking) and mandible movement capacity.
Measured: Day 1
Smartphone Addiction Scale Short Form
Each item is scored between 1-6. The high score informs about the severity of smartphone addiction. Those who have a total score above 29.50 are considered as smartphone addiction.
Measured: Day 1
Secondary outcomes (1)
Pittsburgh Sleep Quality Index
It is a reliable, valid and standardized scale that measures sleep quality over a one-month period and provides clinical evaluation of various sleep disorders that may affect sleep quality.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start15 Apr 2022
- Primary completion15 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smartphone Addiction, Temporomandibular Joint DysfunctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Abit Kocaman, Kırıkkale University
- Investigators
- Ayşe Abit Kocaman, PhD, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331989
- Sponsor's protocol ID
- SmartphoneAddictionandneckpain
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Can HB, Tuna F. Relation between endurance of deep cervical flexor muscles and physical activity level, perceived stress, sleep quality, and smartphone addiction. Cranio. 2022 Mar;40(2):126-134. doi: 10.1080/08869634.2020.1724457. Epub 2020 Feb 6.
PubMed 32028877
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Addiction and Temporomandibular Joint Dysfunction in Individuals With Nonspecific Neck Pain
- ClinicalTrials.gov ID
- NCT05331989
- Acronym / sponsor ID
- SmartphoneAddictionandneckpain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 18 Apr 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.
It has been reported that excessive use of smartphones increases the stress on the cervical spine, and changes in cervical curvature and pain in the muscles around the neck are associated with the increase in stress. Studies have reported that smartphone users with addictions have neck pain (68%), upper back pain (62%), right shoulder pain (52%), left shoulder pain (46%), and right hand pain (46%). As a result of our study, the frequency of smartphone addiction and temporomandibular joint dysfunction and related factors in individuals with nonspecific neck pain were examined and the results we obtained will contribute to the literature.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient group,healthy group | – | Other: patient group/ healthy groupCranio- Cervical Flexion Test, cervical mobility, Pressure Pain Threshold,Functional evaluation of the temporomandibular joint,Pittsburg Sleep Quality Index |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Individuals with nonspecific neck pain, individuals who voluntarily agreed to participate in our study and signed the consent form
Key inclusion criteria (4 listed)
- Presence of neck pain lasting at least 6 months
- Being between the ages of 18-45
- Individuals with a score between 10-40 points according to the Neck Disability Index
- Individuals who have never had a history of shoulder or neck surgery
Key exclusion criteria (7 listed)
- Individuals with signs of radicular pain (positive neck distraction test, Spurling's neck compression test, and Adson's test)
- Individuals who get less than 10 points or more than 40 points according to the Neck Disability Index
- Those with a previous history of shoulder and neck surgery
- Individuals with accompanying shoulder pain
- Individuals with spinal cord tumors
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 |
|---|---|---|
| patient group/ healthy groupCranio- Cervical Flexion Test, cervical mobility, Pressure Pain Threshold,Functional evaluation of the temporomandibular joint,Pittsburg Sleep Quality Index | Other | patient group,healthy group |
Primary outcome
Cranio- Cervical Flexion Test
Time frame: Day 1
An inflatable pressure unit (StabilizerTM, Chattanooga Group, Inc., Hixson, TN) will be used during testing.
Evaluation of cervical mobility
Time frame: Day 1
Cervical region flexion, extension, lateral flexion and rotation movements will be evaluated with Baseline Bubble Inclinometer.
Evaluation of Pressure Pain Threshold
Time frame: Day 1
Pressure pain threshold assessment will be performed with an algometer, which is an objective assessment method.Measurements will be made from three different regions: anterior temporal muscle body, masseter muscle body and TMJ (lateral to the mandibular condyle).
Functional evaluation of the temporomandibular joint
Time frame: Day 1
The Helkimo Clinic Craniomandibular Index will be used in the evaluation of TMJ (5). This index consists of 5 subsections: pain on muscle palpation, pain on TMJ palpation, pain on mandible functions, TMJ functions (sound, gliding at maximum opening, luxation and/or locking) and mandible movement capacity.
Smartphone Addiction Scale Short Form
Time frame: Day 1
Each item is scored between 1-6. The high score informs about the severity of smartphone addiction. Those who have a total score above 29.50 are considered as smartphone addiction.
1 secondary outcome
Pittsburgh Sleep Quality Index
Time frame: Day 1
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 26 Apr 2023.
- Background: PubMed 32028877Can HB, Tuna F. Relation between endurance of deep cervical flexor muscles and physical activity level, perceived stress, sleep quality, and smartphone addiction. Cranio. 2022 Mar;40(2):126-134. doi: 10.1080/08869634.2020.1724457. Epub 2020 Feb 6.
- Individual participant dataSharing planned: No
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.
Ayşe Abit Kocaman, PhD principal investigator
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smartphone Addiction, Temporomandibular Joint Dysfunction, run by Kırıkkale University 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 7 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 26 Apr 2023. 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?
Cranio- Cervical Flexion Test (time frame: Day 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05331989, which also lists 1 linked publication.
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 26 Apr 2023.