The Effect of Sensory Motor Training on Postural Stability in Post-menopausal Women With Non-specific Low Back Pain

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Core strengthening exercise; Other: sensory motor training

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed K Sayed; Phone Number: +201145554592; Email: elarabi492@gmail.com
• Study Contact Backup: Name: Amir A Gabr, professor; Phone Number: +201222816912; Email: dr.amirarabigabr@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Mohamed Khalaf Sayed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: core strengthening exercise group; The participants will practice core strengthening exercises (3 sessions/ week) for eight weeks.	Other: Core strengthening exercise; 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.
Experimental: Core strengthening exercise and sensory motor training group; The participants will practice core strengthening exercises and sensory motor training (3 sessions/ week) for eight weeks.	Other: Core strengthening exercise; 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.; Other: sensory motor training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mohamed Awad, professor, Cairo University; Study Chair: Dalia Kamel, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: P.T.REC/012/005567

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No