Evaluation of Balance Using the Biodex Balance System Among Different Subcategories of Low Back Pain

NCT ID: NCT07242976

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-02-03

Brief Summary

this study aims to evaluate balance using the biodex balance system among patients with spondylosis, spondylolisthesis, and lumber disc prolapse.

Detailed Description

Low back pain is one of the most common causes of disability globally . While postural balance impairments have been widely documented in individuals with low back pain, there is limited understanding of how these impairments vary across specific subcategories of specific low back pain. Low back pain is generally categorized into non specific and specific types.

Non-specific LBP approximately accounts for 85-90% of all low back pain cases (Hartvigsen et al., 2018). In contrast, specific low back pain arises from a recognizable pathology such as structural abnormalities. The most common causes of specific low back pain are lumbar spondylosis, spondylolisthesis, and lumbar disc prolapse. Lumbar spondylosis has a prevalence of 74% in individuals over 60 years confirmed with radiographic findings. Spondylolisthesis affects approximately 6-11.5% of adults , lumbar disc prolapse accounts for 2-5% of all low back pain cases.

Balance deficiency among patients with spondylosis, spondylolisthesis and lumber disc prolapse was reported in literature by different objective assessment tools. Individuals with low back pain exhibit measurable deficits in balance and postural stability compared to healthy controls . Also, the chronicity of low back pain affects both static and dynamic balance.

Assessment and detection of balance deficiency among patients with spondylosis, spondylolisthesis and lumber disc prolapse will allow physical therapists to design individualized rehabilitation programs. Improve understanding of interventions focusing on core stabilization, proprioceptive retraining and dynamic balance. This may improve postural control, enhance gait performance, reduce fall risk and support better functional outcomes in daily activities.

Thus, there was a need to study the difference in balance using the biodex balance system among patients with spondylosis, spondylolisthesis and lumber disc prolapse. The current study may provide a more conclusive insight in evaluation and treatment of patients with low back pain.

Conditions

Low Back Pain; Spondylolisthesis; Spondylosis Lumbar; Balance Assessment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Group (GI)= will include 20 healthy normal subjects.

Assessment of balance will be measured by The Biodex Balance System (BBS) which computes Postural Stability key indices: the medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and overall stability index (OSI). Each index is further measured in four outcomes: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) for both legs and Single leg eye closed (SLEC) for both legs. Additionally Biodex Balance Systen (BBS) will assess limit of stability in one outcome: Double leg eyes open (DLEO).

Group Type: ACTIVE_COMPARATOR

Assessment of balance will be measured by The Biodex Balance System (BBS) which computes Postural Stability key indices: the medial-lateral stability index (MLSI), anterior-posterior stability index

Intervention Type: DIAGNOSTIC_TEST

Low back pain (LBP) is a leading cause of disability worldwide and is often associated with postural and balance impairments. However, limited evidence exists on how these deficits differ among specific types of LBP such as lumbar spondylosis, spondylolisthesis, and disc prolapse. Understanding these variations is crucial for accurate assessment and targeted rehabilitation. Evaluating balance using the Biodex Balance System can help identify the extent of impairment and guide physiotherapists in developing individualized rehabilitation programs that enhance postural control, stability, and functional performance, ultimately improving quality of life and reducing fall risk among LBP patients.

Group (GII) will include 20 patients with lumbar spondylosis.

Assessment of balance will be measured by The Biodex Balance System (BBS) which computes Postural Stability key indices: the medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and overall stability index (OSI). Each index is further measured in four outcomes: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) for both legs and Single leg eye closed (SLEC) for both legs. Additionally Biodex Balance Systen (BBS) will assess limit of stability in one outcome: Double leg eyes open (DLEO).

Group Type: ACTIVE_COMPARATOR

Assessment of balance will be measured by The Biodex Balance System (BBS) which computes Postural Stability key indices: the medial-lateral stability index (MLSI), anterior-posterior stability index

Intervention Type: DIAGNOSTIC_TEST

Low back pain (LBP) is a leading cause of disability worldwide and is often associated with postural and balance impairments. However, limited evidence exists on how these deficits differ among specific types of LBP such as lumbar spondylosis, spondylolisthesis, and disc prolapse. Understanding these variations is crucial for accurate assessment and targeted rehabilitation. Evaluating balance using the Biodex Balance System can help identify the extent of impairment and guide physiotherapists in developing individualized rehabilitation programs that enhance postural control, stability, and functional performance, ultimately improving quality of life and reducing fall risk among LBP patients.

Group (GIII) will include 20 patients with lumbar spondylolisthesis.

Assessment of balance will be measured by The Biodex Balance System (BBS) which computes Postural Stability key indices: the medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and overall stability index (OSI). Each index is further measured in four outcomes: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) for both legs and Single leg eye closed (SLEC) for both legs. Additionally Biodex Balance Systen (BBS) will assess limit of stability in one outcome: Double leg eyes open (DLEO).

Group Type: ACTIVE_COMPARATOR

Assessment of balance will be measured by The Biodex Balance System (BBS) which computes Postural Stability key indices: the medial-lateral stability index (MLSI), anterior-posterior stability index

Intervention Type: DIAGNOSTIC_TEST

Low back pain (LBP) is a leading cause of disability worldwide and is often associated with postural and balance impairments. However, limited evidence exists on how these deficits differ among specific types of LBP such as lumbar spondylosis, spondylolisthesis, and disc prolapse. Understanding these variations is crucial for accurate assessment and targeted rehabilitation. Evaluating balance using the Biodex Balance System can help identify the extent of impairment and guide physiotherapists in developing individualized rehabilitation programs that enhance postural control, stability, and functional performance, ultimately improving quality of life and reducing fall risk among LBP patients.

Group (GIV) will include 20 patients with lumbar disc prolapse.

Assessment of balance will be measured by The Biodex Balance System (BBS) which computes Postural Stability key indices: the medial-lateral stability index (MLSI), anterior-posterior stability index (APSI), and overall stability index (OSI). Each index is further measured in four outcomes: Double leg eyes open (DLEO), Double leg eyes closed (DLEC), Single leg eye open (SLEO) for both legs and Single leg eye closed (SLEC) for both legs. Additionally Biodex Balance Systen (BBS) will assess limit of stability in one outcome: Double leg eyes open (DLEO).

Group Type: ACTIVE_COMPARATOR

Assessment of balance will be measured by The Biodex Balance System (BBS) which computes Postural Stability key indices: the medial-lateral stability index (MLSI), anterior-posterior stability index

Intervention Type: DIAGNOSTIC_TEST

Low back pain (LBP) is a leading cause of disability worldwide and is often associated with postural and balance impairments. However, limited evidence exists on how these deficits differ among specific types of LBP such as lumbar spondylosis, spondylolisthesis, and disc prolapse. Understanding these variations is crucial for accurate assessment and targeted rehabilitation. Evaluating balance using the Biodex Balance System can help identify the extent of impairment and guide physiotherapists in developing individualized rehabilitation programs that enhance postural control, stability, and functional performance, ultimately improving quality of life and reducing fall risk among LBP patients.

Interventions

Assessment of balance will be measured by The Biodex Balance System (BBS) which computes Postural Stability key indices: the medial-lateral stability index (MLSI), anterior-posterior stability index

Low back pain (LBP) is a leading cause of disability worldwide and is often associated with postural and balance impairments. However, limited evidence exists on how these deficits differ among specific types of LBP such as lumbar spondylosis, spondylolisthesis, and disc prolapse. Understanding these variations is crucial for accurate assessment and targeted rehabilitation. Evaluating balance using the Biodex Balance System can help identify the extent of impairment and guide physiotherapists in developing individualized rehabilitation programs that enhance postural control, stability, and functional performance, ultimately improving quality of life and reducing fall risk among LBP patients.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Arabic Numerical Rating Scale; Arabic version of Oswestry disability index (Ar-ODI)

Eligibility Criteria

Inclusion Criteria

• Diagnosis of chronic low back pain (≥3 months duration) (Ge et al., 2021). Referred from orthopedic surgeons with confirmed diagnosis of lumbar spondylosis, spondylolisthesis or lumber disc prolapse affecting L4-L5 or L5 S1( Hlaing et al., 2020) depending on imaging findings (MRI, CT or X-ray scan within the last 6 months):

• Lumbar spondylosis; defined as degenerative disc disease, osteophyte formation with or without facet joint arthropathy (Natarajan et al., 2021; Christe et al., 2020).
• Lumbar spondylolisthesis; defined as anterolisthesis of one vertebral body over another, graded via the Meyerding scale (grade 1 or 2) (Giordan et al., 2023; Chuang et al., 2018).
• Lumbar disc prolapse; defined as protrusion, herniation of intervertebral disc (Kang et al., 2016; Hahne et al., 2019).

• Age of patients ranges from 35 to 55 years (Albeshri, et.al., 2017)
• Both genders will be included in the study
• Pain intensity: ≥ 4/10 on a numerical pain rating scale (Thong et al., 2011).
• BMI ranged from (18.5-29.9 kg/m²) (Karimi et al., 2008; Soliman et al., 2017).
• Healthy subjects are healthy volunteers and without any Musculoskeletal disorders (Karimi et al., 2008).

Exclusion Criteria

• The following patients will be excluded from the study patients with:

• Prior lumbar spine surgery or neurological disorders (e.g., parkinson's, stroke) that may influence balance (soliman et al., 2017).
• Fractures of the spine, pelvis or lower extremities, (Karimi et al., 2008).
• Leg length discrepancy(Karimi et al., 2008).
• Systemic disease such as arthritis, tuberculosis, liver or kidney failure. (Karimi et al., 2008).
• Patients with chronic non-specific low back pain.
• Patients exhibiting red flag symptoms such as urinary or fecal incontinence, saddle anesthesia, progressive motor deficits (e.g., foot drop), or other signs of serious neurological compromis (Ruhe et al., 2011).
• Participants experiencing low back pain with pain radiating distaly below the level of knee (Hlaing et al., 2020).

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Delta University for Science and Technology

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Muhammed El-sayed Muhammed Abu l Ftouh

Demonstrator at orthopedic department faculty of physical therapy delta university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enas F Yousef, Professor of Physical Therapy

Role: PRINCIPAL_INVESTIGATOR

Physical Therapy for Musculoskeletal Disorders and Its Surgery, Faculty of Physical Therapy, Cairo University

MOAAZ R RIYAD, Lecturer

Role: STUDY_DIRECTOR

Lecturer of Department of Physical Therapy for Musculoskeletal Disorders and Its Surgery

Locations

Faculty of Physical Therapy Delta University

Gamasa, , Egypt

Countries

Egypt

Central Contacts

Muhammed E Abulftouh

Role: CONTACT

ftoh1996@gmail.com

+201023292028

Rewan M Aloush

Role: CONTACT

rewan.aloush@gmail.com

+201024232512

Facility Contacts

MOHAMED A BEHIRY, Assistant Professor

Role: primary

behirycenter@gmail.com

+201005147878

Other Identifiers

BIODEX BALANCE SYSTEM

Identifier Type: -

Identifier Source: org_study_id