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Rheumatoid Arthritis (RA)NCT07627542

An Investigation of the Effect of Smartphone Usage Levels on Cervical Posture, Tongue Pressure, Balance, and Neck Disability in Individuals With Rheumatoid Arthritis and Ankylosing Spondylitis

An observational study of Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS), run by Merve Şahin at 1 site in Turkey (Türkiye).

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Sites and contacts
Official record

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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
How many people
111 participants
Where
1 siteTurkey (Türkiye)
Study dates
9 Apr 2026to Nov 2026
Phase
Observational

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population consists of adult patients diagnosed with Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) who are actively followed at the Rheumatology Outpatient Clinic of Necmettin Erbakan University Faculty of Medicine Hospital. Additionally, age-matched healthy volunteers recruited from the community with no systemic, neurological, or chronic musculoskeletal disorders will serve as the control group. All participants must fulfill the specific age criteria (18 to 65 years) and technological dependency baseline (using a smartphone for at least 2 hours daily).

Who may be able to join

  • Aged 18 to 65 years.
  • Using a smartphone for at least 2 hours daily.
  • Able to understand and follow postural commands during clinical measurements.
  • For the Rheumatoid Arthritis (RA) Group: Diagnosed with RA by a rheumatologist, with a stable disease activity score (DAS28 < 3.2).
  • For the Ankylosing Spondylitis (AS) Group: Diagnosed with AS by a rheumatologist, with a stable disease activity score (BASDAI < 4).

Who cannot join

  • History of prior surgical intervention in the cervical region.
  • Presence of neurological diseases (e.g., Parkinson's disease, ALS).
  • Severe visual or hearing impairment.
  • Vestibular system disorders.
  • Severe limitation in jaw opening.
  • Presence of acute neck trauma or malignancy.
  • Lower extremity amputation or advanced arthritis that prevents performing the balance test.
  • Active use of muscle relaxants or advanced sedative medications.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fatma ERDEO, Assistant Professor contact

+90505 443 17 78

ferdeo@erbakan.edu.tr

Merve ŞAHİN, PT contact

+905528255101

mervesahin5101@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Necmettin Erbakan University Faculty of Medicine Hospital, Rheumatology Outpatient Clinic

    Konya, Meram, 42090

    Mustafa Ç ERGÜN, MD, Assistant Professor, +905055272690, bilgi@erbakan.edu.tr

    Merve ŞAHİN, PT, +905528255101, mervesahin5101@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

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:

  1. Sociodemographic and Descriptive Information Form: Participants will be questioned regarding age, sex, height, body weight, marital status, educational level, smoking habits, medical history, disease duration, active medications, sports participation, daily smartphone/computer/tablet usage duration, and habitual posture/ergonomics during technology use.
  2. Neck Disability Index (NDI): Symptoms and functional limitations will be evaluated using the Turkish validated version of the NDI (Aslan \& Karaduman, 2009). Scoring ranges from 0 to 50, where higher scores indicate greater functional disability.
  3. Smartphone Addiction Scale-Short Version (SAS-SV): Technological dependency will be assessed using the Turkish validated version of the SAS-SV (Noyan et al., 2015). Cut-off values of 31 for males and 33 for females will be utilized to determine addiction status.
  4. Craniovertebral Angle (CVA) Measurement: To objectively assess forward head posture, goniometric measurement will be performed. Anatomical reference points (the spinous process of the C7 vertebra and the tragus of the ear) will be marked. The goniometer center will be aligned with C7, with the stationary arm perpendicular to the ground and the movable arm aligned with the tragus. The average of three measurements with 2-minute rest intervals will be recorded. A CVA below 50° indicates Text Neck/forward head posture.
  5. Neck Extensor Muscle Strength Test: While the participant sits upright, a digital handheld dynamometer probe will be placed at the occipital protuberance. Participants will perform a maximal isometric contraction pushing backward against the probe. The average of three trials with 30-60 second rest intervals will be recorded in Newtons (N).
  6. Single-Leg Stance Test (SLST): Static balance performance will be evaluated on the non-dominant leg (stabilizing limb). The test will be performed three times with eyes open and three times with eyes closed, with a ceiling effect set at 60 seconds. The best scores will be recorded in seconds.
  7. Pressure Pain Threshold (PPT) via Algometry: A digital algometer will be applied perpendicularly to the midpoint of the upper trapezius muscle and the suboccipital region. Pressure will be increased until the participant experiences the first sensation of pain. Two or three measurements will be averaged with 1-minute intervals to ensure reliability.
  8. Tongue Pressure Assessment via IOPI: To evaluate the motor control of swallowing and suprahyoid muscle activity, the Iowa Oral Pressure Instrument (IOPI) will be utilized. An air-filled tongue bulb will be placed on the midline of the hard palate. Participants will press the bulb maximally against the palate for 5 seconds. The maximum value of three trials with 2-minute rest intervals will be recorded in Kilopascals (kPa).

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.

Keywords
Text Neck, Smartphone Addiction, Neck Pain, Postural Balance, Neck Muscle Strength, Tongue Pressure
Medical subject headings
Arthritis, Rheumatoid, Spondylitis, Ankylosing, Internet Addiction Disorder, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07627542
Study groupRoleWhat they receive
Rheumatoid Arthritis (RA) GroupPatients diagnosed with Rheumatoid Arthritis by a rheumatologist, with a stable disease activity score (DAS28 < 3.2), aged 18-65, and using a smartphone for at least 2 hours daily.
Ankylosing Spondylitis (AS) GroupPatients diagnosed with Ankylosing Spondylitis by a rheumatologist, with a stable disease activity score (BASDAI < 4), aged 18-65, and using a smartphone for at least 2 hours daily.
Healthy Control GroupHealthy individual volunteers aged 18-65 with no history of rheumatological, neurological, or chronic musculoskeletal diseases, and using a smartphone for at least 2 hours daily.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smartphone Addiction Scale-Short Version (SAS-SV)

    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.

    Measured: At baseline (Single assessment session)

Secondary outcomes (6)
  1. Neck Disability Index (NDI)

    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)

    Measured: At baseline (Single assessment session)

  2. Craniovertebral Angle (CVA)

    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°).

    Measured: At baseline (Single assessment session)

  3. Neck Extensor Muscle Strength

    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.

    Measured: At baseline (Single assessment session)

  4. Single-Leg Stance Test (SLST) Performance

    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.

    Measured: At baseline (Single assessment session)

  5. Pressure Pain Threshold (PPT)

    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.

    Measured: At baseline (Single assessment session)

  6. Maximum Tongue Pressure

    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.

    Measured: At baseline (Single assessment session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2026
  2. Study start9 Apr 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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
Cross-sectional
Enrolment
111 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07627542
Sponsor's protocol ID
30246.R1
Status last verified
Jun 2026
First submitted
31 May 2026
Last updated
9 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To ensure participant confidentiality and in accordance with the informed consent approved by the institutional ethics committee, individual participant data will not be shared with third parties or made publicly available outside of the primary research team.

Publications

  • Bennett JL, Pratt AG, Dodds R, Sayer AA, Isaacs JD. Rheumatoid sarcopenia: loss of skeletal muscle strength and mass in rheumatoid arthritis. Nat Rev Rheumatol. 2023 Apr;19(4):239-251. doi: 10.1038/s41584-023-00921-9. Epub 2023 Feb 17.

    PubMed 36801919
  • Ahmed EA, Atar S, Atar Y, Sari H, Anarat MEA, Salturk Z, Karaketir SG, Uyar Y, Kuru O. Evaluation of the Swallowing and Voice Functions in Ankylosing Spondylitis Patients. Dysphagia. 2022 Apr;37(2):455-462. doi: 10.1007/s00455-021-10340-1. Epub 2021 Jul 14.

    PubMed 34259915
  • Castien RF, van der Wouden JC, De Hertogh W. Pressure pain thresholds over the cranio-cervical region in headache: a systematic review and meta-analysis. J Headache Pain. 2018 Jan 26;19(1):9. doi: 10.1186/s10194-018-0833-7.

    PubMed 29374331
  • Portelli A, Reid SA. Cervical Proprioception in a Young Population Who Spend Long Periods on Mobile Devices: A 2-Group Comparative Observational Study. J Manipulative Physiol Ther. 2018 Feb;41(2):123-128. doi: 10.1016/j.jmpt.2017.10.004. Epub 2018 Jan 17.

    PubMed 29338884
  • Ulutatar F, Unal-Ulutatar C, Duruoz MT. Cervical proprioceptive impairment in patients with rheumatoid arthritis. Rheumatol Int. 2019 Dec;39(12):2043-2051. doi: 10.1007/s00296-019-04419-0. Epub 2019 Aug 21.

    PubMed 31435752

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