- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482527
Thoracic Mobility Versus Hip Mobility Exercises to Core Stabilization in Lumbar Spondylitis (TME-HME)
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: RAMY GNADY KOMIR, MSc
- Phone Number: +966553277511
- Email: rami33332@yahoo.com
Study Contact Backup
- Name: YAHYA ABDU KULAYBI, MSc
- Phone Number: +966568085421
- Email: yk-pt@hotmail.com
Study Locations
-
-
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Cairo, Egypt
- Faculity Og Physical Therapy in Cairo Univercity
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Contact:
- YAHYA S KULAYBI, MASTER DEGREE
- Phone Number: +966568085421
- Email: yk-pt@hotmail.com
-
Contact:
- MOAAZ RIADH, DOCTORAL DEGREE
- Phone Number: +201007210132
- Email: moaaz.elsakka@gmail.com
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Principal Investigator:
- YAHYA S KULAYBI, MASTER DEGREE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Patients will be referred from an orthopedic surgeon with confirmed diagnosis of lumbar spondylosis with imaging findings (MRI, CT or X-ray reports within the last 6 months) (Battié et al., 2014). 2.Duration of patient's symptoms will be more than 3 months (Oliveira et al., 2022). 3. Patients' age will range from 40-60 years (Kalichman & Hunter, 2008). 4.Localized back pain and pain radiating to lower extremities with no distal involvement below knee with an NPRS more than 3 (Thompson et al., 2021).
Exclusion Criteria:
- Spinal or hip surgery history (Williams et al., 2022).
- Red Flags: Cauda equina syndrome, fracture, infection, malignancy (Finucane et al., 2020).
- Neurological Disorders: Parkinsonism, multiple sclerosis, or other neurological deficits (Odzimek et al., 2023).
- Inflammatory Conditions: Rheumatoid arthritis, ankylosing spondylitis, or infectious spinal disorders (Lee et al., 2018).
- Cognitive Impairment: Unable to understand or follow instructions (Martinez et al., 2024).
- Pregnancy. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Core stabilization exercises (control group)
Before starting the exercise, patients will be taught to reduce the lumbar lordosis by contracting and drawing in the abdominal muscles and to find the 24 lumbar and pelvic neutral position by moving the pelvis forwards and backwards (pelvic tilt, bridge, bird-dog and plank etc.).
In each session, the neutral position will be found first and attention will be paid to maintain the neutral position throughout the exercise.
In addition, core stability exercises including simultaneous contractions of the multifidus and pelvic floor muscles will be given in different positions such as supine, prone, crawling, bridge, kneeling, sitting and standing.
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.
|
Before starting the exercise, patients will be taught to reduce the lumbar lordosis by contracting and drawing in the abdominal muscles and to find the 24 lumbar and pelvic neutral position by moving the pelvis forwards and backwards (pelvic tilt, bridge, bird-dog and plank etc.).
In each session, the neutral position will be found first and attention will be paid to maintain the neutral position throughout the exercise.
In addition, core stability exercises including simultaneous contractions of the multifidus and pelvic floor muscles will be given in different positions such as supine, prone, crawling, bridge, kneeling, sitting and standing.
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.
The exercise will consist of movements in all directions of thoracic spine flexion, extension, lateral flexion, and rotation.
In the thoracic spine extension exercise, both hands will be locked behind the wrists and the back will be placed on a foam roller with the feet positioned 25 flat on the floor.
The knee will be maintained at 90° to perform the extension exercise on the foam roller.
The hands will be locked with the elbow on a chair.
After kneeling, the hip will be moved toward the heels to extend the thoracic spine.
In the thoracic spine flexion exercise, the thoracic spine will be flexed by moving backward until the hip touched the heels in a quadruped position.The rotation exercise will be conducted with patients lying on their sides.The elbows will be straight and the palms will be held together.
The leg facing the ceiling will be bent to the level of the stomach.
Then, the arm facing the ceiling will be moved backward in a large arc to rotate the thoracic spine.
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.
|
|
Experimental: Thoracic Mobility Exercises (1st experimental group only)
The exercise will consist of movements in all directions of thoracic spine flexion, extension, lateral flexion, and rotation.
In the thoracic spine extension exercise, both hands will be locked behind the wrists and the back will be placed on a foam roller with the feet positioned 25 flat on the floor.
The knee will be maintained at 90° to perform the extension exercise on the foam roller.
The hands will be locked with the elbow on a chair.
After kneeling, the hip will be moved toward the heels to extend the thoracic spine.
In the thoracic spine flexion exercise, the thoracic spine will be flexed by moving backward until the hip touched the heels in a quadruped position.The rotation exercise will be conducted with patients lying on their sides.The elbows will be straight and the palms will be held together.
The leg facing the ceiling will be bent to the level of the stomach.
Then, the arm facing the ceiling will be moved backward in a large arc to rotate the thoracic spine.
|
Before starting the exercise, patients will be taught to reduce the lumbar lordosis by contracting and drawing in the abdominal muscles and to find the 24 lumbar and pelvic neutral position by moving the pelvis forwards and backwards (pelvic tilt, bridge, bird-dog and plank etc.).
In each session, the neutral position will be found first and attention will be paid to maintain the neutral position throughout the exercise.
In addition, core stability exercises including simultaneous contractions of the multifidus and pelvic floor muscles will be given in different positions such as supine, prone, crawling, bridge, kneeling, sitting and standing.
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.
|
|
Experimental: Hip Mobility Exercises (2nd experimental group only)
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.
|
Before starting the exercise, patients will be taught to reduce the lumbar lordosis by contracting and drawing in the abdominal muscles and to find the 24 lumbar and pelvic neutral position by moving the pelvis forwards and backwards (pelvic tilt, bridge, bird-dog and plank etc.).
In each session, the neutral position will be found first and attention will be paid to maintain the neutral position throughout the exercise.
In addition, core stability exercises including simultaneous contractions of the multifidus and pelvic floor muscles will be given in different positions such as supine, prone, crawling, bridge, kneeling, sitting and standing.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain levels
Time Frame: (pre-treatment) and after 6 weeks of intervention (post-treatment)
|
Pain levels in participants were assessed using the Numerical Pain Rating Scale (NPRS-Ar).
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(pre-treatment) and after 6 weeks of intervention (post-treatment)
|
|
Disability
Time Frame: (pre-treatment) and after 6 weeks of intervention (post-treatment)
|
Using the Arabic MODI (Appendix III), Patients will be instructed to choose the best answer of the possible answers which describes the level of function and disability during daily activities in each of items of the questionnaire (Alnahdi, 2025).
|
(pre-treatment) and after 6 weeks of intervention (post-treatment)
|
|
Lumbar Range of motion
Time Frame: (pre-treatment) and after 6 weeks of intervention (post-treatment)
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The Back Range of Motion (BROM) device will be utilized to measure the lumbar range of motion (ROM), as a valid and reliable measure of spinal motion (Kumar & Singh, 2021; Chen et al., 2022), according to established procedures (Madson et al., 1999). After palpating and marking the spinous processes of T 12 and S1 with adhesive dots, a warm-up trial for each plane of motion will be completed by patients. The BROM device will be used to measure active ROM in the order of flexion/extension, right/left lateral flexion, and right/left rotation. 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 after 6 weeks of intervention (post-treatment)
|
|
Spinal mobility:
Time Frame: (pre-treatment) and after 6 weeks of intervention (post-treatment)
|
Using the Modified Schober Test, Patient will be standing.
The examiner will mark both posterior superior iliac spine (PSIS) and then will draw a horizontal line at the center of both marks.
A second line is marked 5 cm below the first line.
A third line is marked 10 cm above the first line.
Patient will be instructed to flex forward as if attempting to touch his/her toes.
The examiner re measures the distance between the top and bottom line (Rezvani et al., 2012).
Three trials will be conducted and the mean of the three trials will be chosen for the purpose of data analysis
|
(pre-treatment) and after 6 weeks of intervention (post-treatment)
|
|
Fear of movement
Time Frame: (pre-treatment) and after 6 weeks of intervention (post-treatment)
|
Using the Arabic Tampa (Appendix V), Patients will be asked about any excessive, irrational, and debilitating fear of physical movement and activity resulting from a feeling of vulnerability to painful injury or re-injury (Al Shudifat et al., 2020).
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(pre-treatment) and after 6 weeks of intervention (post-treatment)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: MOAAZ RAGAB RIYAD, PhD, CAIRO UNIVERCITY
Publications and helpful links
General Publications
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Study Completion (Estimated)
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First Submitted That Met QC Criteria
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- P.T.REC/012/006229
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Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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