- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06453499
Silent Lumbar Disc Herniation Syndrome
June 9, 2024 updated by: Noha Khaled Shoukry
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
Study Overview
Detailed Description
An observational study will be conducted on 180 individuals without any back or lower extremity symptoms.
Individuals who agree to participate in the study will be divided into 3 groups based on their MRI findings.
Group 1 (silent disc herniation group): has LDH and root compression confirmed by the MRI but has no back or lower extremity symptoms.
Group 2 (had a history of disc herniation with an improvement of their symptoms after receiving physical therapy intervention): has LDH and root compression confirmed by the MRI but has no back or lower extremity symptoms.
Group 3 (control group): absence of LDH and root compression confirmed by the MRI has no back or lower extremity symptoms.
The isokinetic peak torque for knee and ankle muscles and the H reflex will be assessed for all the individual investigating the influence of silent LDH on the isokinetic parameters and the H-reflex of the lower extremity may help in better guiding for lower extremity screening to identify individuals at risk for lower extremity injuries.
It is hoped that clinicians will incorporate such information to understand the importance of confirming the improvemnt obtained from the physical therapy intervention with an MRI before discharging the patients to reduce the risk of recurrence……………………………………………………………………………..…………………………………………………………………………………………………………………..
Study Type
Observational
Enrollment (Estimated)
180
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Giza, Egypt, 12556
- Recruiting
- Faculty of Physical Therapy
-
Contact:
- Abeer Farag, PhD
- Phone Number: 01063044443
- Email: abeerfarag22@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-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
Description
Inclusion Criteria:
- Inclusion criteria patients with LDH and root compression with 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
physical therapy
core stability exercise
|
ultrasound for 5 minutes,Tens and hot packs for 20 minutes, back exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MRI of lumbar disc
Time Frame: three months
|
presence or absence of disc herniation will be confirmed by MRI
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2024
Study Registration Dates
First Submitted
June 4, 2024
First Submitted That Met QC Criteria
June 9, 2024
First Posted (Actual)
June 11, 2024
Study Record Updates
Last Update Posted (Actual)
June 11, 2024
Last Update Submitted That Met QC Criteria
June 9, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PCU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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