NCT07018154

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

May 31, 2025

Last Update Submit

June 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Core strength

    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.

    6 months post-procedure

Secondary Outcomes (3)

  • Balance control

    6 months post-procedure

  • Spinal mobility

    6 months post-procedure

  • Hamstring flexibility

    6 months post-procedure

Study Arms (2)

Group A

Female patients with chronic nonspecific low back pain (NS-LBP).

Other: Musculoskeletal Assessment

Group B

Male patients with chronic nonspecific low back pain (NS-LBP).

Other: Musculoskeletal Assessment

Interventions

Patients underwent a musculoskeletal Assessment.

Group AGroup B

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The current 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 nonspecific low back pain (NS-LBP).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University (Physical therapy)

Cairo, 12613, Egypt

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans SyndromeLow Back Pain

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bachlor of Physical Therapy, Cairo University, Cairo, Egypt

Study Record Dates

First Submitted

May 31, 2025

First Posted

June 12, 2025

Study Start

September 1, 2024

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations