NCT07013786

Brief Summary

This study aims to investigate the relationship between motor control dysfunction (MCD) and radiographic parameters in non-specific chronic low back pain (NSCLBP). Participants will undergo specific clinical motor control tests and lumbar spine X-rays to evaluate the alignment and coordination of spinal and pelvic structures. Understanding this relationship may help improve rehabilitation strategies and reduce pain in affected individuals.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

29 days

First QC Date

May 30, 2025

Last Update Submit

June 6, 2025

Conditions

Keywords

Lumbar motor control dysfunctionLumbopelvic parametersRadiographic alignmentTransverse abdominisMultifidus

Outcome Measures

Primary Outcomes (5)

  • Lumbar Lordotic Angle

    Radiographic measurement of the lumbar lordotic angle (LLA) in degrees to assess sagittal spinal alignment in patients diagnosed with non-specific chronic low back pain.

    At baseline (during initial assessment visit)

  • Pelvic Incidence Angle

    Measurement of Pelvic Incidence Angle in degrees obtained from lateral radiographic imaging in patients with non-specific chronic low back pain.

    At baseline (during initial assessment visit)

  • Pelvic Tilt Angle

    Assessment of pelvic tilt angle in degrees as part of the evaluation of lumbopelvic alignment in patients with non-specific chronic low back pain.

    At baseline (during initial assessment visit)

  • Sacral Slope Angle

    Evaluation of sacral slope angle in degrees based on standard radiographic imaging in patients with non-specific chronic low back pain.

    At baseline (during initial assessment visit)

  • Lumbar Motor Control Assessment via Pressure Biofeedback during ADIM

    Evaluation of lumbar motor control using pressure biofeedback during the Abdominal Draw-In Maneuver (ADIM) from crook lying and prone position. Pressure changes in mmHg will be recorded to assess the ability to maintain abdominal contraction.

    At baseline (during initial assessment visit)

Study Arms (1)

NSCLBP Patients

Patients aged 20-40 years diagnosed with non-specific chronic low back pain (NSCLBP). Participants will undergo assessment of lumbar motor control using a pressure biofeedback unit in two positions (crock lying and prone). Additionally, radiographic imaging will be performed to measure lumbopelvic parameters, including pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), and lumbar lordotic angle (LLA), to analyze their correlation with motor control dysfunction.

Diagnostic Test: Pressure biofeedback assessment

Interventions

Participants will be assessed for lumbar motor control using a pressure biofeedback unit (PBU) during the Abdominal Draw-In Maneuver (ADIM) in both crock lying and prone positions. This is a non-invasive test to evaluate deep core muscle function (TrA and MF) in patients with NSCLBP. No therapeutic intervention will be administered.

NSCLBP Patients

Eligibility Criteria

Age20 Years - 40 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth males and females with NSCLBP are eligible to participate based on biological sex.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 20-40 years diagnosed with non-specific chronic low back pain (NSCLBP), recruited from the outpatient physical therapy clinic of Cairo University. Participants will be screened based on clinical and radiographic criteria to ensure eligibility and safety.

You may qualify if:

  • Patients diagnosed with non-specific chronic low back pain (NSCLBP) for more than 3 months
  • Age between 20 and 40 years
  • Both males and females
  • Body mass index (BMI) between 18.5 and 29.9
  • No physical therapy or medical treatment during the last 3 months
  • Able and willing to provide informed consent

You may not qualify if:

  • Patients with specific causes of low back pain (e.g., disc herniation, fractures, tumors, infections)
  • History of spinal or lower limb surgery or injury
  • Radiculopathy or neurological disorders affecting motor control
  • Diagnosed spinal deformities (e.g., scoliosis, spondyloarthropathy, ankylosing spondylitis)
  • Contraindications to X-ray (e.g., pregnancy)
  • Patients currently undergoing physical therapy or medical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Saragiotto BT, Maher CG, Yamato TP, Costa LO, Menezes Costa LC, Ostelo RW, Macedo LG. Motor control exercise for chronic non-specific low-back pain. Cochrane Database Syst Rev. 2016 Jan 8;2016(1):CD012004. doi: 10.1002/14651858.CD012004.

    PMID: 26742533BACKGROUND

Study Officials

  • Enas Fawzy Youssef, Phd,MSc,PSc

    Cairo university- Faculty of physical therapy

    PRINCIPAL INVESTIGATOR
  • Nevien Ezzat Elliethy, Phd,MSc,PSc

    Cairo university- faculty of medicine,department of radiology

    PRINCIPAL INVESTIGATOR
  • Tasneem Ehab Mohammad, Phd,MSc,PSc

    Cairo university- Faculty of physical therapy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Abdelazeem Saad, MSc, BSc

CONTACT

Mahmoud Mohammad Ali, Phd,MSc,PSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Correlation between motor control dysfunction and radiographic parameter in non specific chronic low back pain

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 10, 2025

Study Start

June 1, 2025

Primary Completion

June 30, 2025

Study Completion

July 30, 2025

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to privacy concerns and institutional policy. The study is conducted as part of an academic thesis and is not intended for open data sharing.