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

NCT06769230 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005567
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Assessment of function disability

  8 weeks

Study Arms (2)

core strengthening exercise group

ACTIVE COMPARATOR

The participants will practice core strengthening exercises (3 sessions/ week) for eight weeks.

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.

Other: Core strengthening exercise; Other: sensory motor training

Interventions

Core strengthening exercise OTHER

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.

Core strengthening exercise and sensory motor training group; core strengthening exercise group

sensory motor training OTHER

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.

Core strengthening exercise and sensory motor training group

Eligibility Criteria

• Age: 50 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mohamed Khalaf Sayed

Cairo, Egypt

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Awad, professor

  Cairo University

  STUDY DIRECTOR

• Dalia Kamel, Professor

  Cairo University

  STUDY CHAIR

Central Study Contacts

Mohamed K Sayed

CONTACT

+201145554592; elarabi492@gmail.com

Amir A Gabr, professor

CONTACT

+201222816912; dr.amirarabigabr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 10, 2025
• Study Start: January 15, 2025
• Primary Completion: June 15, 2025
• Study Completion: June 30, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Locations

EG (1)