NCT06453499

Brief Summary

LDH is a common phenomenon that is often described in association with various pathological processes affecting the neuromuscular and locomotor systems. It is not only associated with pathology but it can also be observed in healthy individuals with no evidence of any dysfunction. Since LDH is observed in such a large percentage of healthy subjects, it is probably more appropriate to perceive it as a physiological phenomenon with silent clinical biomechanical changes

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

February 1, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

1.6 years

First QC Date

June 4, 2024

Last Update Submit

June 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • MRI of lumbar disc

    presence or absence of disc herniation will be confirmed by MRI

    three months

Study Arms (1)

physical therapy

core stability exercise

Other: Physical therapy

Interventions

ultrasound for 5 minutes,Tens and hot packs for 20 minutes, back exercise

physical therapy

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A convenience sample of 180 adult males with a mean age of 40-50 years will be recruited to participate in the study. Inclusion criteria for the study groups (Group 1 and 2) LDH and root compression with no back or lower extremity symtoms. Inclusion criteria for the control group (Group 3) absence of LDH and root compression, no back or lower extremity symptoms. Exclusion criteria: Any previous history that would affect the alignment or the motion to lower extremity joints as fractures or surgery. Any fixed deformity True leg length discrepancy (\>5mm).Any medical condition affecting peripheral nerves as diabetes mellitus.Any neuromuscular dysfunction and vestibular disorder.Sacroiliac pain or dysfunction low back pain.Radicular or referred or radiating pain Previous lower extremity injury

You may not qualify if:

  • Any previous history that would affect the alignment or the motion to lower extremity joints as fractures or surgery.
  • Any fixed deformity True leg length discrepancy (\>5mm). Any medical condition affecting peripheral nerves as diabetes mellitus. Any neuromuscular dysfunction and vestibular disorder.Sacroiliac pain or dysfunction low back pain.
  • Radicular or referred or radiating pain Previous lower extremity injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy

Giza, 12556, Egypt

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

June 4, 2024

First Posted

June 11, 2024

Study Start

February 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations