Low Back PainNCT06769230
The Effect of Sensory Motor Training on Postural Stability in Post-menopausal Women With Non-specific Low Back Pain
A study testing Core strengthening exercise and sensory motor training in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The study will be conducted to determine the effect of sensory-motor training on postural stability in post-menopausal women with non-specific low back pain. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Core strengthening exercise and sensory motor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All women suffering from non-specific low back pain for at least 3 months.
- Their ages will be ranged from 50-65 years.
- They will be at least 3 years post menopause.
- Their body mass index (BMI) will be less than 30 kg/m2.
Who cannot join
- Musculoskeletal injuries.
- Cardiovascular, respiratory or neurological disorders or psychiatric problem.
- Spinal deformity, bone fracture.
- Back surgery experience.
- Hormone replacement therapy and females with cancer.
- Sensory neuropathy and nervous system problems.
- Middle ear or vestibular problems.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The study will be conducted to determine the effect of sensory-motor training on postural stability in post-menopausal women with non-specific low back pain.
Read the detailed description
Low back pain (LBP) primarily affects postmenopausal women between the ages of 45-60, and it causes distress on social and economic levels Postmenopausal women with non-specific low back pain (NSLBP) and decreased function often feel anxious and sad, which affects their work, sexual and social lives Neuromuscular rehabilitation techniques addressing sensory deficiencies have emerged in recent years and have received increasing therapeutic attention. These techniques could broadly be summarized as sensorimotor training (SMT) methods aiming at increased proprioceptive input to improve motor response in dynamic environments. This might lead to improved quality of postural control, which in turn may alleviate postural specific musculoskeletal pain.
As it promotes proximal stability and distal mobility, Core muscles Stabilization Exercises (CSE) are becoming a more significant part of the treatments. The use of CSE is promoted as a general physical therapy approach for NSLBP. Overtime, CES have improved, focusing more and more on maintaining spinal stability. Theoretical ideas for the treatment of spinal ailments that aid in reducing pain and enhancing function in patients with LBP significantly support the use of CSE. CSE trains muscle activity patterns without unnecessarily overloading the tissue, enhances aerobic fitness, spinal mobility, muscle strength, motor co-ordination and can help to stabilize the spine at a quite cost affordable price and reduce low back pain.
- Conditions
- Low Back Pain
- Being tested
- Core strengthening exercise, sensory motor training
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core strengthening exerciseOther
The participants will perform warm-up exercises including Cat and Camel, spinal movement (spinal flexion and extension cycles), and stretching exercises for the calf, hamstrings, quadriceps and lower back for about 5 minutes. After that, the women will be asked to perform core stability exercises including abdominal hollowing, bilateral knee raise, supine extension Bridge, straight leg rise from prone and alternate arm and leg raise from quadruped. Each exercise will be repeated for 10 times with 7-8 seconds hold and will be increased by four repetitions each week throughout the interventions. During each repetition for every exercise, the patient will be asked to contract her abdominal muscles and maintain this contraction while maintaining her normal breathing pattern.
sensory motor trainingOther
The participants will perform warm-up exercises including neck rotations, arm circles, ankle rotations, trunk rotations, trunk bending and extending for 5-10 mins. After warm up the women performs Bosu ball exercises including Bosu ball one Leg Bridge, Bosu Crunch, Bosu Sit ups, Bosu compressions, Bosu side crunch and Bosu bodyweight squat . Each exercise will be repeated for 6 repetitions in each set. At least 3 sets of each exercise are performed per session. Each exercise will be increased by five repetitions each week throughout the interventions.The total duration of each session is 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| core strengthening exercise group | Active comparator | The participants will practice core strengthening exercises (3 sessions/ week) for eight weeks. Receives: Other: Core strengthening exercise |
| Core strengthening exercise and sensory motor training group | Experimental | The participants will practice core strengthening exercises and sensory motor training (3 sessions/ week) for eight weeks. Receives: Other: Core strengthening exercise; Other: sensory motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior posterior stability index (APSI)
The Biodex Balance System(Model 950-300, Biodex, Inc., Shirley, NY, USA) will be used to assess posture stability including anterior posterior stability index. It offers 12 levels of platform control and provides up to 20⁰ of surface tilt. Before the participant stepped onto the Biodex Balance System, the platform was in the "locked" position. Participants' data and test parameters were inserted. The parameters will be included trial time (20 seconds), number of trials (3 trials), and in between trials rest (10 seconds). Initial and end stability levels will be set from more to less stable (8-1) respectively. Anterior-posterior stability index (APSI) represents fluctuations from the horizontal around the anteroposterior axis. The higher the value, the lower the anterior posterior stability.
Measured: 8 weeks
Mediolateral stability index (MLSI)
The Biodex Balance System(Model 950-300, Biodex, Inc., Shirley, NY, USA) will be used to assess posture stability including mediolateral stability index. It offers 12 levels of platform control and provides up to 20⁰ of surface tilt. Before the participant stepped onto the Biodex Balance System, the platform was in the "locked" position. Participants' data and test parameters were inserted. The parameters will be included trial time (20 seconds), number of trials (3 trials), and in between trials rest (10 seconds). Initial and end stability levels will be set from more to less stable (8-1) respectively. Medio-lateral stability index (MLSI) represents fluctuations from the horizontal around the mediolateral axis The higher the value, the lower the mediolateral stability index.
Measured: 8 weeks
Overall stability index (OASI)
The Biodex Balance System(Model 950-300, Biodex, Inc., Shirley, NY, USA) will be used to assess posture stability including overall stability index. It offers 12 levels of platform control and provides up to 20⁰ of surface tilt. Before the participant stepped onto the Biodex Balance System, the platform was in the "locked" position. Participants' data and test parameters were inserted. The parameters will be included trial time (20 seconds), number of trials (3 trials), and in between trials rest (10 seconds). Initial and end stability levels will be set from more to less stable (8-1) respectively. Overall stability index (OSI) is a composite of MLSI and APSI so it is sensitive to changes in both directions. These indices are standard deviations assessing fluctuations around the zero point from the horizontal rather than around the group mean. Higher values indicate more deviations and poor balance control
Measured: 8 weeks
Pain intensity level
The visual analog scale (VAS) will be used to assess pain severity for all participants before and after the treatment. It is a valid pain rating scale and it is used to assess pain severity. It consists of a 10 cm straight line with two end points such as 0 is 'no pain at all' and 10 'pain as worse pain.
Measured: 8 weeks
Pain pressure threshold (PPT)
The pressure algometry (12-0303 Push-Pull Force Gauge, Fabrication Enterprises, Inc., USA) with a probe size of 1.0 cm2 will be used to assess pain pressure threshold for all participants before and after the treatment..
The pressure will be applied on the trigger points at 3 cm lateral to the spinous processes (L1-S5).The reading was expressed in Kg/cm2.
During PPT measurement, assessor will place the circular probe perpendicular to the skin and press, the participant will be asked to say "stop" when feels pressure or discomfort. Four consecutive PPT measures will be performed at each site with 30 seconds of rest between measurements then the PPT of all trigger points will be averaged and used for analysis.
Measured: 8 weeks
Secondary outcomes (1)
Assessment of function disability
The Arabic version of Oswestry Disability Index (ODI) will be used to assess the function disability level of all participants before and after treatment. It consists of ten sections with six responses about daily activities. For each section the total score is 5; if the first statement is marked the score = 0; if the last statement is marked the score = 5. Intervening statements are scored according to rank. If more than one box is marked in each section, take the highest score. If all ten sections are completed the score is calculated as follows: Example: 16 (total score) of 50 (total possible score) × 100 = 32 %. If one section is missed (or not applicable) the score is calculated as follows: Example: 16 (total score)/45 (total possible score) × 100 = 35.6 %. A low score = low degree of disability, a high score = high degree of disability
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khalaf Sayed, Cairo University
- Investigators
- Mohamed Awad, professor, Study director, Cairo UniversityDalia Kamel, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769230
- Sponsor's protocol ID
- P.T.REC/012/005567
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sensory Motor Training on Postural Stability in Post-menopausal Women With Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT06769230
- Acronym / sponsor ID
- P.T.REC/012/005567
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will be conducted to determine the effect of sensory-motor training on postural stability in post-menopausal women with non-specific low back pain.
Detailed description
Low back pain (LBP) primarily affects postmenopausal women between the ages of 45-60, and it causes distress on social and economic levels Postmenopausal women with non-specific low back pain (NSLBP) and decreased function often feel anxious and sad, which affects their work, sexual and social lives Neuromuscular rehabilitation techniques addressing sensory deficiencies have emerged in recent years and have received increasing therapeutic attention. These techniques could broadly be summarized as sensorimotor training (SMT) methods aiming at increased proprioceptive input to improve motor response in dynamic environments. This might lead to improved quality of postural control, which in turn may alleviate postural specific musculoskeletal pain.
As it promotes proximal stability and distal mobility, Core muscles Stabilization Exercises (CSE) are becoming a more significant part of the treatments. The use of CSE is promoted as a general physical therapy approach for NSLBP. Overtime, CES have improved, focusing more and more on maintaining spinal stability. Theoretical ideas for the treatment of spinal ailments that aid in reducing pain and enhancing function in patients with LBP significantly support the use of CSE. CSE trains muscle activity patterns without unnecessarily overloading the tissue, enhances aerobic fitness, spinal mobility, muscle strength, motor co-ordination and can help to stabilize the spine at a quite cost affordable price and reduce low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| core strengthening exercise group | Active comparator | Other: Core strengthening exerciseThe participants will practice core strengthening exercises (3 sessions/ week) for eight weeks. |
| Core strengthening exercise and sensory motor training group | Experimental | Other: Core strengthening exercise, Other: sensory motor trainingThe participants will practice core strengthening exercises and sensory motor training (3 sessions/ week) for eight weeks. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All women suffering from non-specific low back pain for at least 3 months.
- Their ages will be ranged from 50-65 years.
- They will be at least 3 years post menopause.
- Their body mass index (BMI) will be less than 30 kg/m2.
Key exclusion criteria (7 listed)
- Musculoskeletal injuries.
- Cardiovascular, respiratory or neurological disorders or psychiatric problem.
- Spinal deformity, bone fracture.
- Back surgery experience.
- Hormone replacement therapy and females with cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core strengthening exerciseThe participants will perform warm-up exercises including Cat and Camel, spinal movement (spinal flexion and extension cycles), and stretching exercises for the calf, hamstrings, quadriceps and lower back for about 5 minutes. After that, the women will be asked to perform core stability exercises including abdominal hollowing, bilateral knee raise, supine extension Bridge, straight leg rise from prone and alternate arm and leg raise from quadruped. Each exercise will be repeated for 10 times with 7-8 seconds hold and will be increased by four repetitions each week throughout the interventions. During each repetition for every exercise, the patient will be asked to contract her abdominal muscles and maintain this contraction while maintaining her normal breathing pattern. | Other | Core strengthening exercise and sensory motor training group, core strengthening exercise group |
| sensory motor trainingThe participants will perform warm-up exercises including neck rotations, arm circles, ankle rotations, trunk rotations, trunk bending and extending for 5-10 mins. After warm up the women performs Bosu ball exercises including Bosu ball one Leg Bridge, Bosu Crunch, Bosu Sit ups, Bosu compressions, Bosu side crunch and Bosu bodyweight squat . Each exercise will be repeated for 6 repetitions in each set. At least 3 sets of each exercise are performed per session. Each exercise will be increased by five repetitions each week throughout the interventions.The total duration of each session is 45 minutes. | Other | Core strengthening exercise and sensory motor training group |
Primary outcome
Anterior posterior stability index (APSI)
Time frame: 8 weeks
The Biodex Balance System(Model 950-300, Biodex, Inc., Shirley, NY, USA) will be used to assess posture stability including anterior posterior stability index. It offers 12 levels of platform control and provides up to 20⁰ of surface tilt. Before the participant stepped onto the Biodex Balance System, the platform was in the "locked" position. Participants' data and test parameters were inserted. The parameters will be included trial time (20 seconds), number of trials (3 trials), and in between trials rest (10 seconds). Initial and end stability levels will be set from more to less stable (8-1) respectively. Anterior-posterior stability index (APSI) represents fluctuations from the horizontal around the anteroposterior axis. The higher the value, the lower the anterior posterior stability.
Mediolateral stability index (MLSI)
Time frame: 8 weeks
The Biodex Balance System(Model 950-300, Biodex, Inc., Shirley, NY, USA) will be used to assess posture stability including mediolateral stability index. It offers 12 levels of platform control and provides up to 20⁰ of surface tilt. Before the participant stepped onto the Biodex Balance System, the platform was in the "locked" position. Participants' data and test parameters were inserted. The parameters will be included trial time (20 seconds), number of trials (3 trials), and in between trials rest (10 seconds). Initial and end stability levels will be set from more to less stable (8-1) respectively. Medio-lateral stability index (MLSI) represents fluctuations from the horizontal around the mediolateral axis The higher the value, the lower the mediolateral stability index.
Overall stability index (OASI)
Time frame: 8 weeks
The Biodex Balance System(Model 950-300, Biodex, Inc., Shirley, NY, USA) will be used to assess posture stability including overall stability index. It offers 12 levels of platform control and provides up to 20⁰ of surface tilt. Before the participant stepped onto the Biodex Balance System, the platform was in the "locked" position. Participants' data and test parameters were inserted. The parameters will be included trial time (20 seconds), number of trials (3 trials), and in between trials rest (10 seconds). Initial and end stability levels will be set from more to less stable (8-1) respectively. Overall stability index (OSI) is a composite of MLSI and APSI so it is sensitive to changes in both directions. These indices are standard deviations assessing fluctuations around the zero point from the horizontal rather than around the group mean. Higher values indicate more deviations and poor balance control
Pain intensity level
Time frame: 8 weeks
The visual analog scale (VAS) will be used to assess pain severity for all participants before and after the treatment. It is a valid pain rating scale and it is used to assess pain severity. It consists of a 10 cm straight line with two end points such as 0 is 'no pain at all' and 10 'pain as worse pain.
Pain pressure threshold (PPT)
Time frame: 8 weeks
The pressure algometry (12-0303 Push-Pull Force Gauge, Fabrication Enterprises, Inc., USA) with a probe size of 1.0 cm2 will be used to assess pain pressure threshold for all participants before and after the treatment.. The pressure will be applied on the trigger points at 3 cm lateral to the spinous processes (L1-S5).The reading was expressed in Kg/cm2. During PPT measurement, assessor will place the circular probe perpendicular to the skin and press, the participant will be asked to say "stop" when feels pressure or discomfort. Four consecutive PPT measures will be performed at each site with 30 seconds of rest between measurements then the PPT of all trigger points will be averaged and used for analysis.
1 secondary outcome
Assessment of function disability
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Awad, professor study director
Cairo University
Dalia Kamel, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core strengthening exercise and sensory motor training in people with Low Back Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed K Sayed (+201145554592, elarabi492@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior posterior stability index (APSI) (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.