NCT06720103

Brief Summary

This study will be conducted to answer the following question: Is there a Correlation Between Lumbar Radiculopathy and Quality of Life in Patients with chronic lumbar spondylosis?

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
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2024

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

December 3, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

December 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2025

Completed
Last Updated

December 6, 2024

Status Verified

November 1, 2024

Enrollment Period

2 months

First QC Date

December 3, 2024

Last Update Submit

December 3, 2024

Conditions

Keywords

quality of liferadiculopathylumbar spondylosis

Outcome Measures

Primary Outcomes (1)

  • life disability

    WHOQOL questionnaire will be used to assess life disability. it is defined as the individual's perception of their QoL. It consists of 24 questions which cover 4 categories plus 2 questions related to scale and health satisfaction. Each individual item of the WHOQOL-BRIEF is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale.

    up to one day

Secondary Outcomes (2)

  • sciatic radiculopathy

    up to one day

  • mechanosensitivity of the neuromeningeal structures within the vertebral canal

    up to one day

Study Arms (1)

lumbar spondylosis patients

one hundred thirty-two subjects (who have chronic lumbar spondylosis); from both genders will participate in this group.

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

one hundred thirty-two subjects (who have chronic lumbar spondylosis); from both genders will participate in this study.

You may qualify if:

  • All patient diagnosed and referred from a physician
  • Patients suffered from lumbar spondylosis (L4: L5) with radiculopathy more than 3 months
  • Participants will be from both gender
  • Age will be ranged from 30 to 50.
  • BMI of all participants ≤ 30 kg/m2

You may not qualify if:

  • Pregnant and breast-feeding women
  • Patients diagnosed with depression and anxiety
  • Patient who had undergone lumbar spine surgery
  • People with systemic illnesses or physical deformities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

SpondylosisRadiculopathy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

mona Ali, master

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principale investigator: mona abdelmageed ali

Study Record Dates

First Submitted

December 3, 2024

First Posted

December 6, 2024

Study Start

December 20, 2024

Primary Completion

February 25, 2025

Study Completion

February 25, 2025

Last Updated

December 6, 2024

Record last verified: 2024-11