- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07482527
Thorakal mobilitet versus hofte mobilitetsøvelser til kerne stabilisering ved lumbal spondylitis (TME-HME)
Thoraxmobilitet kontra hofte mobilitetsøvelser til core stabilisering ved lumbal spondylitis
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
- Adfærdsmæssigt: Group A : Core stabilization exercises (control group)
- Adfærdsmæssigt: Group B: Thoracic Mobility Exercises (1st experimental group only)
- Adfærdsmæssigt: GROUP B CORE STABILIZATION PROGRAM
- Adfærdsmæssigt: Group C: Hip Mobility Exercises (2nd experimental group only)
- Adfærdsmæssigt: GROUP C CORE STABILIZATION PROGRAM
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Cairo, Egypten
- Faculity Og Physical Therapy in Cairo Univercity
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Disability.
Tidsramme: pre-treatment and 6 weeks of intervention (post-treatment).
|
Questionnaire measuring functional disability caused by low back pain. Modified Oswestry Disability Index Arabic Version (MODI-Ar). |
pre-treatment and 6 weeks of intervention (post-treatment).
|
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Pain intensity
Tidsramme: pre-treatment and 6 weeks of intervention (post-treatment).
|
Pain intensity assessed by using the Numerical Pain Rating Scale (NPRS-Ar) consist of 11 points from 0-10 ( 0) mean no pain and (10) maximum pain . |
pre-treatment and 6 weeks of intervention (post-treatment).
|
|
Lumbar Range of motion
Tidsramme: pre-treatment and 6 weeks of intervention (post-treatment).
|
The Back Range of Motion (BROM) device will be utilized to measure the lumbar range of motion (ROM). The BROM device will be used to measure active ROM in the order of flexion/extension, right/left lateral flexion, and right/left rotation and the value from 0 degree 360 degre which 0 means no motion and 360 max motion. Once the data for each movement was taken, the BROM device was removed, and the skin markers were reapplied after a 10-15 second rest period. Each motion will have three trials, and data from the three trials will be averaged and used for analysis in order to maximize reliability. |
pre-treatment and 6 weeks of intervention (post-treatment).
|
|
Spinal mobility.
Tidsramme: pre-treatment and 6 weeks of intervention (post-treatment).
|
Using Modified Schober Test . to measurement of lumbar spine flexion where 15cm above and 5cm below the lumbosacral junction (L5-S1) is marked and the difference in distance is measured on forward flexion. |
pre-treatment and 6 weeks of intervention (post-treatment).
|
|
Fear of movement.
Tidsramme: pre-treatment and 6 weeks of intervention (post-treatment).
|
Using (Tampa Scale for Kinesiophobia Arabic Version (Tampa-Ar). to measures fear of movement and re-injury in patients with chronic musculoskeletal pain, on a 4-point Likert scale (1=strongly disagree to 4=strongly agree). |
pre-treatment and 6 weeks of intervention (post-treatment).
|
|
Quality of life
Tidsramme: pre-treatment and 6 weeks of intervention (post-treatment).
|
measured by RAND 36-Items health syrvey which measures physical and emotional and social functioning the total score 100 and higher score means good health. |
pre-treatment and 6 weeks of intervention (post-treatment).
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: MOAAZ R EL SAKKA, PhD, CAIRO UNIVERCITY
Publikationer og nyttige links
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