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Completed

NCT Number: NCT07018154

Gender Differences in Musculoskeletal Assessment Methods in Patients With Chronic Mechanical Low Back Pain

This study is an observational test-retest study designed to investigate the effect of gender on core strength, balance, spinal mobility, and hamstring flexibility in patients with chronic non-specific low back pain (NS-LBP).

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Key information

About this study

Low back pain (LBP) is the primary contributor to years of disability. Individual features (age, physical fitness), psychosocial factors (stress, anxiety, and depression), and occupational factors (hard physical work, bending and twisting motions, and vibration) have all been linked to the development of LBP, which is thought to have a complex etiology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both sexes will be involved.
  • Patients suffer from chronic NS-LBP for more than 3 months.
  • Patients' age ranges from 18 to 40 years, and body mass index ranges from 18 to 25 kg/m2.
  • Patients with sufficient cognitive abilities that enable them to understand and follow instructions.

Exclusion criteria

  • History of spinal trauma or fractures.
  • Osteoporotic patients.
  • Patients using analgesics during the last 3 months.
  • Pregnant or lactating females.
  • Neurological musculoskeletal diseases that affect the lower back (eg, spondylosis, spondylolisthesis, disc injuries).
  • Previous spinal surgery.
  • Posture deformities.
  • Cauda equina symptoms related to the spine, including changes in bowel and bladder control.
  • Signs of severe pathology (eg, malignancy, inflammatory disorders).
  • Patients with severe psychiatric disorders.

Treatment and study plan

Musculoskeletal Assessment

Other

Patients underwent a musculoskeletal Assessment.

Primary outcomes

  1. Core strength

    Time frame: 6 months post-procedure

    Measurement of core strength was done with the patient in the crooked lying position. Then, the cuff of the device was held under the lower back of the patient, and the patient was instructed to press against this cuff, tuck his abdomen, and hold the contraction.

Secondary outcomes

  1. Balance control

    Time frame: 6 months post-procedure

    Romberg's test was used to assess static balance control. Each patient was tested in a single-leg stance with their eyes open on both a stable surface and then on an unstable surface. For the starting position, each patient stands on their dominant leg (determined by the football kicking test), with the unsupported leg in a neutral hip and 90-degree knee flexion position, and their arms crossed at chest level; the examiner observes this position for 60 seconds. In each test condition (SS and SUS), each patient was asked to maintain the position, and the duration for which they held the position was recorded.

  2. Spinal mobility

    Time frame: 6 months post-procedure

    The Mini-Mental State Examination (MMSE) was used to measure lumbar flexion and extension range of motion. The measurements were taken in a neutral standing position. A line connecting the two posterior superior iliac spines was drawn. Then, two points in the middle of the line and 15 cm above were marked. With lumbar flexion or extension, the distance between the two points was measured and subtracted from the 15 cm distance

  3. Hamstring flexibility

    Time frame: 6 months post-procedure

    To begin the hamstring flexibility test, the patient sits on the floor with both feet straight forward against a box. Both knees were pressed down to the floor. With the palms facing downwards, and the hands side by side, the subject stretched forward four times and held the position of maximum reach on the fourth count. The patient was asked to maintain the position for two counts. The most distant line touched by the fingertips of both hands was noted, and the distance was measured in cm.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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