- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07673575
EFFECT OF MULLIGAN CERVICAL SUSTAINED NATURAL APOPHYSEAL GLIDE ON POSTURAL STABILITY IN PATIENTS WITH CHRONIC NECK PAIN (SNAG Mulligan)
This study seeks to address the identified research gap by objectively investigating the effect of Mulligan Cervical SNAGs on postural stability in individuals with chronic neck pain and mobility impairments. The findings aim to provide evidence-based insights into whether restoring joint mobility through this manual intervention can effectively enhance sensorimotor control and balance performance. The study aims to determine if adding SNAG to a conventional exercise program provides superior improvements in balance indices (OSI, APSI, MLSI), Pain, functional disability, Range of motion, Joint position sense, and kinesiophobia compared to exercise alone. The primary purpose of this study is to answer the following research questions:
- Does the application of cervical SNAGs lead to a significant improvement in the postural stability of patients with chronic neck pain with mobility deficits?
- Is there a correlation between the improvement in cervical range of motion (ROM) following SNAGs and the enhancement of postural control performance?
Přehled studie
Postavení
Podmínky
Intervence / Léčba
- Diagnostický test: 1- The Biodex Balance System (BBS)
- Diagnostický test: 2-The Numerical Pain Rating Scale (NPRS)
- Diagnostický test: 3- The Neck Disability Index (Arabic version) for functional disability
- Diagnostický test: 4- Digital Inclinometer for Cervical Range of Motion
- Diagnostický test: 5- Arabic Tampa Scale of Kinesiophobia (TSK-11)
- Diagnostický test: 6- Overhead LASER pointer for Cervical proprioception
- Jiný: Mulligan Cervical SNAG Technique Protocol
- Jiný: Conventional therapy group
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Menna-Allah A Elnaggar, demonstrator
- Telefonní číslo: +201069014391
- E-mail: me370433@gmail.com
Studijní záloha kontaktů
- Jméno: Rewan M Aloush, Teaching Assistant
- Telefonní číslo: +201024232512
- E-mail: rewan.aloush@gmail.com
Studijní místa
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Gamasa, Egypt
- Faculty of Physical Therapy Delta University
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Vrchní vyšetřovatel:
- Dr. Akram fathy abdulhamid, Assistant Professor
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Dílčí vyšetřovatel:
- Mohamed Behiry, Assistant Professor
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Dílčí vyšetřovatel:
- Mahmoud Nabhan, lecturer
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
The patients will be selected according to the following criteria:
- Adults aged between 20 and 45 years
- Body mass index from 18.5 - 24.99 kg/ m2.
- Chronic neck pain lasting ≥3 months
- Diagnosis of neck pain with mobility deficits, including restricted cervical ROM, and pain provoked with movement
- Presence of cervical hypomobility confirmed by segmental mobility assessment on clinical examination
- Pain intensity ≥3/10 on the numerical Pain Rating Scale
- Reduced cervical range of motion in at least one direction measured objectively (by digital inclinometer)
- Ability to stand independently without assistive devices (required for postural stability assessment)
Exclusion Criteria:
The patients will be excluded if they present with:
- Specific causes of neck pain, such as fracture, tumor, infection, inflammatory disease, or cervical myelopathy, confirmed by X Ray and physical examination
- Cervical radiculopathy or neurological deficits (e.g., dermatomal sensory loss, reflex changes, or muscle weakness)
- History of cervical spine surgery or recent trauma (within the last 6 months)
- Vestibular disorders or conditions affecting balance (e.g., vertigo unrelated to cervical origin)
- Temporomandibular disorders, significant shoulder pathology, and shoulder surgeries that may influence cervical movement or outcomes
- Participation in physiotherapy or manual therapy for neck pain within the previous 3 months
- Pregnancy or any medical condition contraindicates manual therapy
- History of chronic ankle instability
- Any lower limb pathology affecting balance
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Group A will include 22 patients with chronic neck pain with mobility deficits
Group A (Experimental: Mulligan cervical SNAG plus conventional physiotherapy) (Mulligan Cervical SNAG Plus Conventional Therapy) Mulligan Cervical SNAG Technique Protocol:
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The Biodex Balance System SD Model 950-441(Biodex Medical Systems, Inc.) is a multi-dimensional (static and dynamic) postural control assessment and training system.
It provides objective, valid, and reliable measures of a patient's ability to balance on stable and unstable surfaces.
It measures the overall Stability Index (OSI), anterior/posterior stability index (APSI), and medial/lateral stability index (MLSI).
Its intraclass correlation coefficient (ICC) reliability is R = 0.92 (OSI), R = 0.89 (APSI), and R = 0.93 (MLSI).
Chronic neck pain subjects have demonstrated significantly worse Biodex balance performance across OSI, APSI, and MLSI
The Numerical Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity that serves as a segmented numerical version of the visual analog scale (VAS). It consists of an 11-point scale where the respondent selects a whole number from 0 to 10 that best reflects the intensity of their pain, with 0 representing "no pain" and 10 representing the "worst imaginable pain" . The NPRS has demonstrated high construct and criterion validity for assessing pain severity in patients with chronic musculoskeletal disorders. It is considered a valid tool for differentiating pain characteristics between individuals with chronic neck pain and healthy controls. The research suggests that the NPRS is often more responsive to clinical changes and easier for patients to comprehend than the traditional VAS .This scale is characterized by excellent test-retest reliability (ICC: 0.95),
Neck disability index (NDI) is self-reported assessment includes ten items: pain severity, personal care, lifting, work, headaches, concentration, sleeping, driving, reading, and recreation.
Higher scores imply a greater level of disability.
Arabic version of the NDI was used to assess Arabic patients with neck pain, as the Arabic version of the NDI is reliable and valid
A digital inclinometer is a handheld electronic device used to objectively measure the degrees of spinal curvature by detecting inclination relative to the force of gravity.In cervical spine assessment, it is used to quantify movements including flexion, extension, lateral flexion, and rotation.The digital inclinometer is recognized as a highly valid and reliable instrument for measuring cervical range of motion (CROM).
Recent studies have reported excellent intra-rater and inter-rater reliability (ICC > 0.85), particularly for cervical rotation and lateral flexion.
It is often preferred over traditional goniometry because it provides precise, objective, and quantitative data that is less susceptible to manual measurement error.
The TSK-11 is a shortened, 11-item version of the original Tampa Scale, designed to assess kinesiophobia.
Defined as an irrational and debilitating fear of physical movement resulting from a feeling of vulnerability to painful injury or re-injury .
The Arabic version was developed to provide a linguistically and culturally adapted tool for assessing fear-avoidance beliefs in Arabic-speaking populations.
The Arabic version of the TSK-11 has been cross- culturally validated and demonstrates strong psychometric properties.
It exhibits high internal consistency, with Cronbach's alpha values typically ranging from 0.86 to 0.90, and excellent test-retest reliability.
It shows significant concurrent validity, as scores are strongly correlated with pain intensity (NPRS) and functional disability measures like the Neck Disability Index.
An overhead LASER pointer will be used to assess cervical proprioception by performing the Cervical Joint Position Error (JPE) test.
The Joint Position Sense Error (JPSE) is considered one of the essential measures to clinically assess cervical proprioception.
The test has good (ICC: 0.77-0.78)
Patient positioning: Seated or standing, with spine in neutral or slight flexion.
Technique variations: • Minor adjustments in force direction to optimize symptom reduction. Based on the American Physical Therapy Association (APTA) Clinical Practice Guidelines for Neck Pain with Mobility Deficits, participants in the conventional therapy group received a multimodal treatment program consisting of mobility exercises, strengthening and endurance training, stretching exercises, and patient education
Sequencing: • SNAG mobilizations performed at session start, followed by active exercises and stretching Manual therapy timing: • SNAG component adds ~10 minutes to a 20-minute exercise session |
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Jiný: Group B = 22 patients with chronic neck pain with mobility deficits
Control Group (Conventional Therapy Only)
Protocol structure:
Typical regimen:
|
The Biodex Balance System SD Model 950-441(Biodex Medical Systems, Inc.) is a multi-dimensional (static and dynamic) postural control assessment and training system.
It provides objective, valid, and reliable measures of a patient's ability to balance on stable and unstable surfaces.
It measures the overall Stability Index (OSI), anterior/posterior stability index (APSI), and medial/lateral stability index (MLSI).
Its intraclass correlation coefficient (ICC) reliability is R = 0.92 (OSI), R = 0.89 (APSI), and R = 0.93 (MLSI).
Chronic neck pain subjects have demonstrated significantly worse Biodex balance performance across OSI, APSI, and MLSI
The Numerical Pain Rating Scale (NPRS) is a unidimensional measure of pain intensity that serves as a segmented numerical version of the visual analog scale (VAS). It consists of an 11-point scale where the respondent selects a whole number from 0 to 10 that best reflects the intensity of their pain, with 0 representing "no pain" and 10 representing the "worst imaginable pain" . The NPRS has demonstrated high construct and criterion validity for assessing pain severity in patients with chronic musculoskeletal disorders. It is considered a valid tool for differentiating pain characteristics between individuals with chronic neck pain and healthy controls. The research suggests that the NPRS is often more responsive to clinical changes and easier for patients to comprehend than the traditional VAS .This scale is characterized by excellent test-retest reliability (ICC: 0.95),
Neck disability index (NDI) is self-reported assessment includes ten items: pain severity, personal care, lifting, work, headaches, concentration, sleeping, driving, reading, and recreation.
Higher scores imply a greater level of disability.
Arabic version of the NDI was used to assess Arabic patients with neck pain, as the Arabic version of the NDI is reliable and valid
A digital inclinometer is a handheld electronic device used to objectively measure the degrees of spinal curvature by detecting inclination relative to the force of gravity.In cervical spine assessment, it is used to quantify movements including flexion, extension, lateral flexion, and rotation.The digital inclinometer is recognized as a highly valid and reliable instrument for measuring cervical range of motion (CROM).
Recent studies have reported excellent intra-rater and inter-rater reliability (ICC > 0.85), particularly for cervical rotation and lateral flexion.
It is often preferred over traditional goniometry because it provides precise, objective, and quantitative data that is less susceptible to manual measurement error.
The TSK-11 is a shortened, 11-item version of the original Tampa Scale, designed to assess kinesiophobia.
Defined as an irrational and debilitating fear of physical movement resulting from a feeling of vulnerability to painful injury or re-injury .
The Arabic version was developed to provide a linguistically and culturally adapted tool for assessing fear-avoidance beliefs in Arabic-speaking populations.
The Arabic version of the TSK-11 has been cross- culturally validated and demonstrates strong psychometric properties.
It exhibits high internal consistency, with Cronbach's alpha values typically ranging from 0.86 to 0.90, and excellent test-retest reliability.
It shows significant concurrent validity, as scores are strongly correlated with pain intensity (NPRS) and functional disability measures like the Neck Disability Index.
An overhead LASER pointer will be used to assess cervical proprioception by performing the Cervical Joint Position Error (JPE) test.
The Joint Position Sense Error (JPSE) is considered one of the essential measures to clinically assess cervical proprioception.
The test has good (ICC: 0.77-0.78)
Based on the American Physical Therapy Association (APTA) Clinical Practice Guidelines for Neck Pain with Mobility Deficits, participants in the conventional therapy group received a multimodal treatment program consisting of mobility exercises, strengthening and endurance training, stretching exercises, and patient education
Sequencing: • SNAG mobilizations performed at session start, followed by active exercises and stretching Manual therapy timing: • SNAG component adds ~10 minutes to a 20-minute exercise session |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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A) Postural Stability (Biodex Balance System)
Časové okno: before the intervention, after 8 weeks, and at a 4-week follow- up.
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Overall Stability Index (OSI) - total amount of platform deviation.
(Higher scores = worse balance Reliability Evidence
For chronic cervical pain with hypomobility, the most appropriate Biodex protocol (supported by evidence) is:
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before the intervention, after 8 weeks, and at a 4-week follow- up.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Numerical Pain Rating Scale (NPRS)
Časové okno: before the intervention, after 8 weeks, and at a 4-week follow- up.
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The NPRS is an 11-point self-reported scale (0-10) for pain intensity.
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before the intervention, after 8 weeks, and at a 4-week follow- up.
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Neck Disability Index (Arabic Version)
Časové okno: before the intervention, after 8 weeks, and at a 4-week follow- up.
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The Arabic NDI is validated and used widely in neck pain research.
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before the intervention, after 8 weeks, and at a 4-week follow- up.
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Digital Inclinometer for Cervical ROM
Časové okno: before the intervention, after 8 weeks, and at a 4-week follow- up.
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Multiple studies describe standardized inclinometer protocols Devices show good validity compared with 3D motion capture
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before the intervention, after 8 weeks, and at a 4-week follow- up.
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Tampa Scale of Kinesiophobia (TSK-11, Arabic Version)
Časové okno: before the intervention, after 8 weeks, and at a 4-week follow- up.
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Kinesiophobia was assessed using the Arabic version of the Tampa Scale of Kinesiophobia (TSK-AV-11), which is a valid and reliable tool for evaluating fear of movement in Arabic-speaking patients. It consists of 11 items scored on a 4-point Likert scale, with higher scores indicating greater fear of movement Brief and validated for chronic pain including neck pain Contains 11 items, each scored 1 (strongly disagree) to 5 (strongly agree). Procedure
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before the intervention, after 8 weeks, and at a 4-week follow- up.
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Overhead Laser Pointer for Cervical Proprioception (Joint Position Error Test)
Časové okno: before the intervention, after 8 weeks, and at a 4-week follow- up.
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Setup
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before the intervention, after 8 weeks, and at a 4-week follow- up.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
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První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- Mulligan on chronic neck pain
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