- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07482527
Thorakal mobilitet kontra hofte mobilitetsøvelser til kjerne stabilisering ved lumbal spondylitt (TME-HME)
Brysthøydebevegelighet mot hoftebevegelighet øvelser for kjerne stabilisering i lumbal spondylitt
This study is conducted to determine the effect of thoracic mobility versus hip mobility exercises to core stabilization on pain severity (NPRS-Ar), functional disability (MODI-Ar), lumbar range of motion (BROM), spinal mobility (modified schober test), quality of life (SF-36-Ar) and fear of movement (Tampa-Ar) in treatment of patients with lumbar spondylitis.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
- Atferdsmessig: Group A : Core stabilization exercises (control group)
- Atferdsmessig: Group B: Thoracic Mobility Exercises (1st experimental group only)
- Atferdsmessig: GROUP B CORE STABILIZATION PROGRAM
- Atferdsmessig: Group C: Hip Mobility Exercises (2nd experimental group only)
- Atferdsmessig: GROUP C CORE STABILIZATION PROGRAM
Detaljert beskrivelse
This study is conducted to determine the effect of thoracic mobility versus hip mobility exercises to core stabilization on pain severity
, functional disability , lumbar range of motion , spinal mobility , quality of life and fear of movement in treatment of patients with lumbar spondylitis.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Cairo, Egypt
- Faculity Og Physical Therapy in Cairo Univercity
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- lumbar spondylitis diagnosis (symptoms will be more than 3 months) ..
- Patients' age from 40-60 years .
- Localized back pain and pain radiating to lower extremities
Exclusion Criteria:
- Spinal or hip surgery .
- pregnancy .
- Neurological Disorders: .
- Inflammatory Conditions: .
- Cognitive Impairment .
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Core stabilization exercises (control group)
In the Core stabilization exercises (control group)patients will receive Core stabilization exercises as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session. The exercises will consist of 3 levels (from easy to difficult). In the advanced level exercises, resistance limb exercises will be added and the exercises will be completed gradually. Each exercise will be performed for 3 sets of 8-10 repetition. |
Core stabilization exercises include Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball In each session. The exercises will consist of 3 levels (from easy to difficult). In the advanced level exercises, patients will be asked to maintain the neutral curvature of the lumbar spine, resistance limb exercises will be added and the exercises will be completed gradually. Each exercise will be performed for 3 sets of 8-10 repetition. |
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Eksperimentell: Thoracic Mobility Exercises (1st experimental group only)
In the thoracic Mobility Exercises group ( experimental group B) will receive core stabilization Exercises program(as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session) in addition to thoracic Mobility Exercises as (Thoracic extension with foam roller ,Thoracic extension with chair ,Thoracic flexion in quadruped , Right Thoracic rotation in side lying ,Left Thoracic rotation in side lying , Right kneeling Thoracic rotation , Left kneeling Thoracic rotation , Right Thoracic sitting lateral flexion and Left Thoracic sitting lateral flexion .Each exercise will be performed for 3 sets of 10 repetitions in addition to core stabilization program |
receive thoracic Mobility Exercises as movements in all directions of thoracic spine as (Thoracic extension with foam roller ,Thoracic extension with chair ,Thoracic flexion in quadruped , Right Thoracic rotation in side lying ,Left Thoracic rotation in side lying , Right kneeling Thoracic rotation , Left kneeling Thoracic rotation , Right Thoracic sitting lateral flexion and Left Thoracic sitting lateral flexion) .Each exercise will be performed for 3 sets of 10 repetitions. will receive core stabilization Exercises program(as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session) The exercises will consist of 3 levels (from easy to difficult). In the advanced level exercises, resistance limb exercises will be added and the exercises will be completed gradually. Each exercise will be performed for 3 sets of 8-10 repetition. |
|
Eksperimentell: Hip Mobility Exercises (2nd experimental group only)
will receive core stabilization Exercises program(as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session) in addition to hip mobility exercises program The patients will perform 8 different hip mobility exercises; reverse v-ups, butterfly, frog, internal rotation with foot rise, pike, revolved crescent lunge, pigeon, lunge on the knee. Each exercise will be performed for 2 sets of 20 seconds. |
will receive core stabilization Exercises program(as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session) in addition to hip Mobility Exercises (The patients will perform 8 different hip mobility exercises; reverse v-ups, butterfly, frog, internal rotation with foot rise, pike, revolved crescent lunge, pigeon, lunge on the knee. Each exercise will be performed for 2 sets of 20 seconds). will receive core stabilization Exercises program(as Abdomen Curl ,Supine Bridging ,Bird Dog , Side Bridging , Plank , Curl Up and Sitting On Ball. In each session) The exercises will consist of 3 levels (from easy to difficult). In the advanced level exercises, resistance limb exercises will be added and the exercises will be completed gradually. Each exercise will be performed for 3 sets of 8-10 repetition. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Functional Disability Measured by the Modified Oswestry Disability Index (MODI-Ar)
Tidsramme: Baseline and 6 weeks (post-treatment).
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Functional disability caused by low back pain will be assessed using the Arabic version of the Modified Oswestry Disability Index (MODI-Ar). |
Baseline and 6 weeks (post-treatment).
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Change in Pain Intensity Measured by the Numerical Pain Rating Scale (NPRS-Ar)
Tidsramme: Baseline and 6 weeks (post-treatment).
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Pain intensity will be assessed using the Arabic version of the 11-point Numerical Pain Rating Scale (NPRS-Ar), ranging from 0 (no pain) to 10 (worst possible pain). |
Baseline and 6 weeks (post-treatment).
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Change in Active Lumbar Range of Motion Measured by the Back Range of Motion (BROM) Device.
Tidsramme: Baseline and 6 weeks (post-treatment).
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Active lumbar range of motion will be measured using the Back Range of Motion (BROM) device, including flexion, extension, right and left lateral flexion, and right and left rotation. Each movement will be measured over three trials, and the average value will be used for analysis. |
Baseline and 6 weeks (post-treatment).
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Change in Lumbar Flexion Mobility Measured by the Modified Schober Test.
Tidsramme: Baseline and 6 weeks (post-treatment).
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Lumbar flexion mobility will be assessed using the Modified Schober Test. Skin markings will be placed 15 cm above and 5 cm below the lumbosacral junction (L5-S1). The change in distance during forward trunk flexion will be recorded in centimeters. |
Baseline and 6 weeks (post-treatment).
|
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Change in Fear of Movement and Re-Injury Measured by the Tampa Scale for Kinesiophobia (TSK-Ar).
Tidsramme: Baseline and 6 weeks (post-treatment).
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Fear of movement and re-injury will be assessed using the Arabic version of the Tampa Scale for Kinesiophobia (TSK-Ar), which evaluates fear of movement and physical activity using a 4-point Likert scale. |
Baseline and 6 weeks (post-treatment).
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Change in Health-Related Quality of Life Measured by the RAND 36-Item Health Survey (RAND-36).
Tidsramme: Baseline and 6 weeks (post-treatment).
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Health-related quality of life will be assessed using the RAND 36-Item Health Survey, which evaluates physical functioning, emotional well-being, social functioning, and other health-related domains. Each domain is scored from 0 to 100, with higher scores indicating better health status. |
Baseline and 6 weeks (post-treatment).
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: MOAAZ R EL SAKKA, PhD, CAIRO UNIVERCITY
Publikasjoner og nyttige lenker
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