- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07613879
Mulligan Mobilization and Stabilization Exercises for Sensorimotor Function in Women With Text Neck Syndrome
23. maj 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
38
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Denizli, Tyrkiet (Türkiye)
- Pamukkale University, Faculty of Physiotherapy and Rehabilitation.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Visual Analogue Scale (VAS)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline and Post-treatment (4 weeks)
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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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline and Post-treatment (4 weeks)
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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)
Tidsramme: Baseline and Post-treatment (4 weeks)
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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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Smartphone Addiction Scale-Short Version (SAS-SV)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2025
Primær færdiggørelse (Faktiske)
4. maj 2026
Studieafslutning (Faktiske)
4. maj 2026
Datoer for studieregistrering
Først indsendt
23. maj 2026
Først indsendt, der opfyldte QC-kriterier
23. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- E-60116787-020-734914
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