- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07613879
Mulligan Mobilization and Stabilization Exercises for Sensorimotor Function in Women With Text Neck Syndrome
23 maja 2026 zaktualizowane przez: Borna Farhoomand, Pamukkale University
The Effects of Mulligan Mobilization Technique and Stabilization Training on Sensorimotor Function in Women With Text Message Neck Syndrome: A Single-Blind Randomized Controlled Trial
Text message neck syndrome represents a significant epidemiological and musculoskeletal concern arising from repetitive strain and prolonged cervical flexion during mobile device operation.
Anatomical deviations associated with this syndrome, such as anterior head translation and altered lower cervical alignment, substantially increase the gravitational load exerted on the cervical spine.
This progressive mechanical overload predisposes individuals to microtraumas, paraspinal muscle imbalances, and secondary proprioceptive impairments.
Kinematic variations further heighten the clinical vulnerability of female populations, as distinct sagittal and thoracic parameters accelerate the progression of postural dysfunction.Conventional therapeutic strategies frequently target localized cervical symptoms, often neglecting the broader kinetic chain and the interdependent relationship between the cervical and thoracic segments.
To address these limitations, this clinical trial evaluates a holistic "joint-by-joint" rehabilitation framework by incorporating thoracic spine interventions into both active protocols.
The Mulligan Mobilization Technique combines passive manual facet joint glides with active physiological movements to restore biomechanical alignment and reduce nociceptive mechanical stress.
Conversely, the Spinal Stabilization Training Protocol focuses on neuromuscular control, utilizing a pressure biofeedback unit and progressive resistance to enhance the endurance of deep cervical flexors and stabilize the scapulothoracic region.A major gap in text neck syndrome literature is the reliance on subjective pain scales, leaving the underlying neurobiological mechanisms under-investigated.
This study introduces an objective biochemically validated assessment model by quantifying objective biomarkers of neurogenic inflammation, nociception, and central sensitization.
By analyzing pre- and post-intervention serum concentrations of Calcitonin Gene-Related Peptide (CGRP) and Substance P via enzyme-linked immunosorbent assay (ELISA), this trial aims to correlate clinical sensorimotor and postural improvements with neurochemical changes.
Ultimately, the findings will clarify whether passive manual joint mobilization or progressive active stabilization exercise provides superior efficacy in restoring sensorimotor function, optimizing postural stability, and mitigating chronic neurogenic pain pathways.
Przegląd badań
Status
Zakończony
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
38
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Denizli, Turcja (Türkiye)
- Pamukkale University, Faculty of Physiotherapy and Rehabilitation.
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Opis
Inclusion Criteria:
- Female sex.
- Age between 18_30 years.
- History of chronic neck pain lasting for at least 3 months.
- Objective diagnosis of Text Message Neck Syndrome via photographic posture analysis (classified into posture categories 3 or 4).
- History of smartphone ownership for at least 1 year.
- Minimum daily smartphone or tablet usage of 1 hour.
- Neck pain intensity score of 3.5 centimeters or higher on the Visual Analog Scale (VAS).
- Neck Disability Index (NDI) score of 5 points or higher.
Exclusion Criteria:
- Diagnosis of scoliosis or cervical disc herniation following neurological and radiological examinations.
- History of prior spinal surgery.
- Presence of concurrent musculoskeletal pathologies, including shoulder pathologies or thoracic outlet syndrome.
- Diagnosed psychiatric disorders.
- History of physical therapy or conservative treatment for neck pain within the past year.
- Presence of specific spinal or systemic pathologies, such as malignancy, acute fracture, or rheumatic disease.
- Uncorrected visual deficits.
- Presence of confounding neurological or systemic illnesses.
- Demonstration of an intervention adherence rate below 80% (completing fewer than 10 out of the 12 scheduled treatment sessions).
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Mulligan Mobilization Group
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A targeted manual therapy protocol directed at the cervical and thoracic spine, administered individually for 12 sessions over a 4-week period (3 sessions per week).
The intervention combines passive accessory facet joint glides with active physiological movements to restore biomechanical alignment and reduce mechanical nociceptive inputs.
The protocol incorporates Natural Apophyseal Glides (NAGs) applied as passive, rhythmic oscillatory glides antero-superiorly along the cervical facet joint planes.
This is followed by Sustained Natural Apophyseal Glides (SNAGs) combined with active physiological neck movements and manual end-range overpressure.
To comprehensively address the kinetic chain, Reverse Natural Apophyseal Glides (RNAGs) are directed cranio-ventrally along the transverse processes of the T1-T4 and T4-T6 thoracic vertebral segments.
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Eksperymentalny: Spinal Stabilization Exercises
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A structured, progressive neuromuscular exercise protocol conducted individually for 12 sessions over a 4-week period (3 sessions per week).
The protocol focuses on enhancing neuromuscular control, deep muscle coordination, and endurance across the craniocervical and scapulothoracic regions.
The intervention consists of three core components: 1) Deep cervical flexor isolation utilizing a pressure biofeedback unit (PBU) placed suboccipitally.
Participants perform controlled craniocervical flexion, advancing sequentially from an initial baseline of 20 mmHg up to a terminal threshold of 30 mmHg (in 2 mmHg increments) using real-time visual feedback, ensuring no substitution of superficial muscles.
2) Isometric chin-tuck stabilization exercises performed against a soft mini-pilates ball to optimize paraspinal muscle activation.
3) Scapulothoracic retraction and thoracic spine extension exercises utilizing progressive elastic resistance bands to stabilize the broader kinetic chain.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Visual Analogue Scale (VAS)
Ramy czasowe: Baseline and Post-treatment (4 weeks)
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A validated 10-centimeter scale used to evaluate the intensity of neck pain.
The scale is anchored at 0 cm (representing "no pain") and 10 cm (representing the "worst imaginable pain").
Baseline severity is categorized as mild (≤ 3.4 cm), moderate (3.5-7.4 cm), and severe (≥7.5 cm).
Higher scores indicate greater pain intensity.
This metric serves both as a primary efficacy outcome and an inclusion criterion (≥3.5 cm).
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Baseline and Post-treatment (4 weeks)
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Neck Disability Index (NDI)
Ramy czasowe: Baseline and Post-treatment (4 weeks)
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The Turkish version of the Neck Disability Index (NDI), used to assess functional impairment related to neck pain.
It comprises 10 items (including pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation).
Each item is scored from 0 (no disability) to 5 (most severe disability), yielding a total cumulative score ranging from 0 to 50.
Higher scores indicate greater functional impairment, categorized as no disability (0-4), mild (5-14), moderate (15-24), severe (25-34), and complete (≥ 35).
The minimal clinically important difference (MCID) is 8.5 to 9.5 points.
This scale serves as both a primary outcome and an inclusion criterion (≥ 5 points).
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Baseline and Post-treatment (4 weeks)
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Cervical Range of Motion (CROM)
Ramy czasowe: Baseline and Post-treatment (4 weeks)
|
Active cervical ROM is assessed across three anatomical planes using the Baseline CROM Deluxe device, which utilizes two gravity-dependent goniometers and a head-mounted compass dial.
Measured movements include cervical flexion, extension, right/left lateral flexion, and right/left rotation, recorded in degrees.
The arithmetic mean of two consecutive trials for each movement is used for analysis.
Higher values indicate greater joint mobility
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Baseline and Post-treatment (4 weeks)
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Cervical Joint Position Sense (JPS)
Ramy czasowe: Baseline and Post-treatment (4 weeks)
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Cervical joint position sense (JPS) is evaluated using the Baseline CROM Deluxe device to measure target repositioning accuracy.
The target angle for each direction is set at 65% of the participant's mean maximum active ROM.
The absolute error between the target angle and the participant's active repositioning attempt is recorded in degrees.
Smaller error values indicate superior proprioceptive accuracy and joint position sense.
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Baseline and Post-treatment (4 weeks)
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Postural Stability (Sway Medical Application)
Ramy czasowe: Baseline and Post-treatment (4 weeks)
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Static postural stability is assessed using the Sway Medical mobile balance application via a triaxial accelerometer.
The protocol involves 5 sequential static standing conditions performed on a firm surface while blindfolded: (1) feet together, (2) tandem stance with left foot forward, (3) tandem stance with right foot forward, (4) single-leg stance on the right, and (5) single-leg stance on the left.
Balance scores are derived from deviance acceleration using proprietary algorithms.
The application generates a composite score ranging from 0 to 100, where higher scores indicate superior postural control and balance.
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Baseline and Post-treatment (4 weeks)
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Dynamic Balance (Y-Balance Test)
Ramy czasowe: Baseline and Post-treatment (4 weeks)
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Dynamic balance is evaluated barefoot using the Y-Balance Test (YBT) in three reach directions: anterior, posterolateral, and posteromedial.
Maximum reach distances are recorded after six practice trials and three formal trials per direction.
Reach distances are normalized to the participant's leg length (measured from the anterior superior iliac spine to the medial malleolus) and expressed as a percentage (%).
A composite score is calculated by averaging the normalized percentages across all three directions, with higher scores representing superior dynamic balance.
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Baseline and Post-treatment (4 weeks)
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Cervical Deep Flexor Muscle Endurance
Ramy czasowe: Baseline and Post-treatment (4 weeks)
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sometric endurance of the deep cervical flexor muscles is assessed using the Cervical Deep Flexor Endurance Test.
Participants in a supine, hook-lying position execute a craniocervical flexion (chin-tuck) maneuver, elevate their head approximately 2.5 cm off the surface, and maintain this position for as long as possible.
The duration is recorded in seconds (s) until termination criteria are met (e.g., loss of alignment, head contact with the surface, acute pain, or participant request).
Longer holding times indicate better muscle endurance.
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Baseline and Post-treatment (4 weeks)
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Gaze Stability (Head-Eye Movement Control Test)
Ramy czasowe: Baseline and Post-treatment (4 weeks)
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Dynamic head-eye coordination and gaze stability are evaluated using the Head-Eye Movement Control Test.
Participants maintain visual fixation on a camera lens during rapid, maximum-range head rotations.
Performance is graded on an ordinal 3-point scale: 0 (stable gaze with coordinated movements), 1 (stable gaze with slightly uncoordinated movements), and 2 (recurrent gaze instability with slow, poorly controlled movements).
Lower scores represent better gaze stability and motor control.
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Baseline and Post-treatment (4 weeks)
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Sagittal Posture Angles (CVA and CTA)
Ramy czasowe: Baseline and Post-treatment (4 weeks)
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Sagittal head and upper thoracic posture are evaluated using digital photogrammetry with retroreflective markers placed on the acoustic tragus, C7 spinous process, and T4 spinous process.
Computerized software calculates two biomechanical parameters in degrees: Craniovertebral Angle (CVA): The angle between the horizontal plane at C7 and the line connecting C7 to the acoustic tragus; smaller values indicate greater forward head posture.Cervicothoracic Angle (CTA): The angle between the line connecting the acoustic tragus to C7 and the line connecting C7 to T4, serving as an index of scapular protraction.
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Baseline and Post-treatment (4 weeks)
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Biochemical Marker: Calcitonin Gene-Related Peptide (CGRP)
Ramy czasowe: Baseline and Post-treatment (4 weeks)
|
Quantification of serum CGRP, a biochemical marker of neurogenic inflammation and nociception.
Venous blood samples (5 mL) are collected, coagulated, centrifuged at 3500 rpm for 10 minutes, and stored at -20°C.
Quantitative determination is performed via a specific human sandwich enzyme-linked immunosorbent assay (ELISA) kit.
Optical density is measured at 450 nm.
Concentrations are reported in picograms per milliliter (pg/mL), with an analytical detection range of 3 to 200 pg/mL.
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Baseline and Post-treatment (4 weeks)
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Biochemical Marker: Substance P (SP)
Ramy czasowe: Baseline and Post-treatment (4 weeks)
|
Quantification of serum Substance P (SP) concentration to evaluate neurogenic inflammation.
Venous blood processing and storage follow the same standardized centrifugation protocol as CGRP.
Quantitative analysis is performed via a specific human sandwich ELISA kit at a controlled temperature of 25°C.
Optical density is measured at 450 nm.
Results are expressed in picograms per milliliter (pg/mL), with an analytical detection range of 3 to 200 pg/mL.
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Baseline and Post-treatment (4 weeks)
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Smartphone Addiction Scale-Short Version (SAS-SV)
Ramy czasowe: Baseline
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The Turkish version of the SAS-SV, used to assess the baseline severity and risk of smartphone addiction in the study population.
The scale comprises 10 uni-dimensional items, each scored on a 6-point Likert scale (1 to 6).
The cumulative total score ranges between 10 and 60 points, where higher composite scores signify an increased risk and greater severity of smartphone addiction.
This serves as a baseline descriptive and stratifying covariate rather than a post-treatment efficacy indicator.
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Baseline
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Treatment Adherence Rate
Ramy czasowe: Up to 4 weeks (over the 12 scheduled individual sessions)
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Treatment compliance is systematically monitored on a per-session basis, documenting the exact number of sessions and days attended out of the 12 planned interventions.
The final adherence rate is calculated as the percentage (%) of completed sessions relative to the total planned sessions.
Participants demonstrating an adherence rate below 80% (completing fewer than 10 sessions) are discontinued from the trial.
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Up to 4 weeks (over the 12 scheduled individual sessions)
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Współpracownicy i badacze
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Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 września 2025
Zakończenie podstawowe (Rzeczywisty)
4 maja 2026
Ukończenie studiów (Rzeczywisty)
4 maja 2026
Daty rejestracji na studia
Pierwszy przesłany
23 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 maja 2026
Pierwszy wysłany (Rzeczywisty)
29 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
29 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
23 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- E-60116787-020-734914
Plan dla danych uczestnika indywidualnego (IPD)
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Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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