- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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?
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
- Diagnostische toets: 1- The Biodex Balance System (BBS)
- Diagnostische toets: 2-The Numerical Pain Rating Scale (NPRS)
- Diagnostische toets: 3- The Neck Disability Index (Arabic version) for functional disability
- Diagnostische toets: 4- Digital Inclinometer for Cervical Range of Motion
- Diagnostische toets: 5- Arabic Tampa Scale of Kinesiophobia (TSK-11)
- Diagnostische toets: 6- Overhead LASER pointer for Cervical proprioception
- Ander: Mulligan Cervical SNAG Technique Protocol
- Ander: Conventional therapy group
Gedetailleerde beschrijving
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Menna-Allah A Elnaggar, demonstrator
- Telefoonnummer: +201069014391
- E-mail: me370433@gmail.com
Studie Contact Back-up
- Naam: Rewan M Aloush, Teaching Assistant
- Telefoonnummer: +201024232512
- E-mail: rewan.aloush@gmail.com
Studie Locaties
-
-
-
Gamasa, Egypte
- Faculty of Physical Therapy Delta University
-
Hoofdonderzoeker:
- Dr. Akram fathy abdulhamid, Assistant Professor
-
Onderonderzoeker:
- Mohamed Behiry, Assistant Professor
-
Onderonderzoeker:
- Mahmoud Nabhan, lecturer
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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:
|
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 |
|
Ander: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
A) Postural Stability (Biodex Balance System)
Tijdsspanne: before the intervention, after 8 weeks, and at a 4-week follow- up.
|
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:
|
before the intervention, after 8 weeks, and at a 4-week follow- up.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS)
Tijdsspanne: before the intervention, after 8 weeks, and at a 4-week follow- up.
|
The NPRS is an 11-point self-reported scale (0-10) for pain intensity.
|
before the intervention, after 8 weeks, and at a 4-week follow- up.
|
|
Neck Disability Index (Arabic Version)
Tijdsspanne: before the intervention, after 8 weeks, and at a 4-week follow- up.
|
The Arabic NDI is validated and used widely in neck pain research.
|
before the intervention, after 8 weeks, and at a 4-week follow- up.
|
|
Digital Inclinometer for Cervical ROM
Tijdsspanne: before the intervention, after 8 weeks, and at a 4-week follow- up.
|
Multiple studies describe standardized inclinometer protocols Devices show good validity compared with 3D motion capture
|
before the intervention, after 8 weeks, and at a 4-week follow- up.
|
|
Tampa Scale of Kinesiophobia (TSK-11, Arabic Version)
Tijdsspanne: before the intervention, after 8 weeks, and at a 4-week follow- up.
|
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
|
before the intervention, after 8 weeks, and at a 4-week follow- up.
|
|
Overhead Laser Pointer for Cervical Proprioception (Joint Position Error Test)
Tijdsspanne: before the intervention, after 8 weeks, and at a 4-week follow- up.
|
Setup
|
before the intervention, after 8 weeks, and at a 4-week follow- up.
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- Mulligan on chronic neck pain
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .