Necmettin Erbakan University Faculty of Medicine Hospital, Rheumatology Outpatient Clinic
Konya, Meram, 42090, Turkey (Türkiye)
Location status: Recruiting
Location contact
Merve ŞAHİN, PT
CONTACT
Mustafa Ç ERGÜN, MD, Assistant Professor
CONTACT
NCT Number: NCT07627542
The purpose of this cross-sectional and comparative study is to investigate the impact of smartphone addiction on the cervical posture, musculoskeletal system, balance, and tongue pressure in individuals diagnosed with Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS), and to compare these findings with a healthy control group. Smartphone addiction has become a major contributing factor to postural alterations such as Text Neck Syndrome. This study aims to evaluate and compare the Craniovertebral Angle (CVA), neck extensor muscle strength, Pressure Pain Thresholds (PPT) of the neck and shoulder, Single-Leg Stance (SLS) static balance, and tongue pressure among three distinct groups. A healthy control group will be included as a reference baseline to differentiate the postural and functional deterioration caused by rheumatological diseases from the additional mechanical load imposed by smartphone dependency. To eliminate the misleading effects of acute pain, joint swelling, and severe functional limitations during flare-ups, only patients with stable disease activity (DAS28 < 3.2 for RA and BASDAI < 4 for AS) will be enrolled. This approach aims to examine the pure biomechanical relationship between technological dependency and cervical functions, independent of active systemic inflammation.
Interested in participating?
Request Info18 year–65 year
All sexes
Observational
Konya, Meram, 42090, Turkey (Türkiye)
Location status: Recruiting
Merve ŞAHİN, PT
CONTACT
Mustafa Ç ERGÜN, MD, Assistant Professor
CONTACT
This study is designed as a cross-sectional, comparative, and correlational investigation conducted at the Necmettin Erbakan University Faculty of Medicine Hospital, Rheumatology Outpatient Clinic. The study population will consist of three groups, each comprising 37 participants (Total N = 111): the Rheumatoid Arthritis (RA) group, the Ankylosing Spondylitis (AS) group, and a Healthy Control (HC) group. Participants will be recruited using consecutive sampling according to their eligibility.
Following the written informed consent process in accordance with the Declaration of Helsinki, a single-session comprehensive assessment protocol will be conducted by an experienced physiotherapist. No therapeutic interventions or follow-up procedures will be performed.
The structured evaluation protocol will be executed in the following chronological order:
Statistical analyses will be conducted to evaluate the negative correlations between smartphone addiction and functional parameters (CVA, muscle strength, PPT, balance, and tongue pressure), positive correlations with NDI, and to compare the physical deterioration between the clinical groups and healthy controls.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At baseline (Single assessment session)
The SAS-SV is a 10-item self-reported questionnaire used to evaluate the level of smartphone dependency. Each item is rated on a 6-point Likert scale ranging from 1 (strongly disagree) to 6 (strongly agree). Total scores range from 10 to 60. The cutoff scores were determined to be 31 for men and 33 for women, with higher scores indicating a higher risk and severity of smartphone addiction.
Time frame: At baseline (Single assessment session)
The NDI is a 10-item questionnaire measuring neck pain-related disability and its impact on functional activities. Each item is scored from 0 (no disability) to 5 (total disability). Total scores range from 0 to 50, where higher scores represent greater functional neck impairment and disability. (0-4 points: no disability, 5-14 points: mild disability, 15-24 points: moderate disability, 25-34 points: severe disability, 35 points and above: complete disability)
Time frame: At baseline (Single assessment session)
CVA will be measured in degrees using a manual goniometer to objectively assess forward head posture. The center of the goniometer will be placed on the C7 spinous process, with one arm vertical to the ground and the other pointing to the tragus of the ear. The average of three trials will be recorded. A lower angle indicates a greater severity of forward head posture (cutoff value is 50°).
Time frame: At baseline (Single assessment session)
Neck extensor strength will be evaluated using a digital handheld dynamometer placed at the level of the occipital protuberance while the participant sits upright. Participants will perform three maximal isometric contractions pushing backward, and the average value will be recorded in Newtons (N). Higher values indicate better muscle strength.
Time frame: At baseline (Single assessment session)
Static balance performance will be evaluated on the non-dominant leg with eyes open and eyes closed. The duration the participant maintains balance will be recorded in seconds, with a maximum ceiling effect of 60 seconds. Higher durations indicate better static balance stability.
Time frame: At baseline (Single assessment session)
The PPT will be measured using a digital algometer applied perpendicularly to the midpoint of the upper trapezius muscle and the suboccipital region. Pressure will be increased gradually, and the value at which the participant feels the first sensation of pain will be recorded in kg/cm². Higher threshold values indicate less pain sensitivity.
Time frame: At baseline (Single assessment session)
Maximum isometric tongue pressure will be evaluated using the Iowa Oral Pressure Instrument (IOPI). Participants will press an air-filled rubber bulb placed at the midline of the hard palate as hard as possible for 5 seconds. The maximum value of three trials will be recorded in Kilopascals (kPa). Higher values represent greater tongue muscle strength.
Contact information is provided by the study sponsor or research team.
Fatma ERDEO, Assistant Professor
CONTACT
Merve ŞAHİN, PT
CONTACT
Merve Şahin
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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