Disc HerniationNCT06453499
Silent Lumbar Disc Herniation Syndrome
An observational study of Disc Herniation, run by Noha Khaled Shoukry at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Disc Herniation
- What is being tested?
- Physical therapy
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Inclusion criteria patients with LDH and root compression with no back or lower extremity symptoms.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Giza, 12556
Abeer Farag, PhD, 01063044443, abeerfarag22@gmail.com
About this study
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
Read the 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……………………………………………………………………………..…………………………………………………………………………………………………………………..
- Conditions
- Disc Herniation
- Being tested
- Physical therapy
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyOther
ultrasound for 5 minutes,Tens and hot packs for 20 minutes, back exercise
| Study group | Role | What they receive |
|---|---|---|
| physical therapy | core stability exercise Receives: Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI of lumbar disc
presence or absence of disc herniation will be confirmed by MRI
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Feb 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noha Khaled Shoukry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Noha Khaled Shoukry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453499
- Sponsor's protocol ID
- PCU
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silent Lumbar Disc Herniation Syndrome
- ClinicalTrials.gov ID
- NCT06453499
- Acronym / sponsor ID
- PCU
- Conditions
- Disc Herniation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Noha Khaled ShoukryUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| physical therapy | – | Other: Physical therapycore stability exercise |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (1 listed)
- Inclusion criteria patients with LDH and root compression with no back or lower extremity symptoms.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapyultrasound for 5 minutes,Tens and hot packs for 20 minutes, back exercise | Other | physical therapy |
Primary outcome
MRI of lumbar disc
Time frame: three months
presence or absence of disc herniation will be confirmed by MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disc Herniation, run by Noha Khaled Shoukry at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI of lumbar disc (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.