Lumbosacral RadiculopathyNCT06058806
Effects of Multimodal Physical Therapy in Patients With Lumbosacral Radiculopathy
A study testing Multimodal Physical Therapy in people with Lumbosacral Radiculopathy, run by Cairo University at 1 site in Egypt.
Trial summary
Purposes of the study To investigate the effect of Multimodal Physical Therapy on pain, daiablility H-reflex, and Diffusion Tensor Imaging (DTI) Parameters in Patients With Lumbosacral Radiculopathy. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- Multimodal Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 20 Jan 2020
- Phase
- Interventional
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic (≥ 3 months) unilateral Lumbosacral Radiculopathy (LSR)
- The LSR is due to paracentral L4-L5 or L5-S1 Lumbar disc herniation
- The LSR is confirmed radiologically by MRI
- The LSR is confirmed clinically by history and physical examination
- The LSR is confirmed neurophysiological by soleus H-reflex assessment
- Body mass Index less than 30
- 20-45 years of age
Who cannot join
- systematic disease
- Bilateral symptoms
- Lumbar spinal stenosis
- previous surgery
- Steroid injection
- Spinal fracture
Show all 11Show fewer
- Lumbar spinal stenosis
- Spinal deformity
- Spinal fracture
- Radiological evidence of bilateral nerve root encroachmen
- Evidence of H-reflex amplitude or latency affection on asymptomatic side
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Faculty of Physical Therapy, Cairo University
Giza
About this study
Official title: Effects of Multimodal Physical Therapy on Pain, Disability, H-reflex, and Diffusion Tensor Imaging Parameters in Patients With Lumbosacral Radiculopathy
Purposes of the study
To investigate the effect of Multimodal Physical Therapy on pain, daiablility H-reflex, and Diffusion Tensor Imaging (DTI) Parameters in Patients With Lumbosacral Radiculopathy.
Read the detailed description
Participants will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- Multimodal Physical Therapy
- Keywords
- Lumbosacral Radiculopathy, Lumbar disc herniation
- 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.
Multimodal Physical TherapyOther
Also called Physical Therapy, Physiotherapy
Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Physical Therapy | Experimental | Patients in this group will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises. Receives: Other: Multimodal Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual analog scale (VAS)
Measured: Change from Baseline pain at 6 weaks
Disability
Roland-Morris Disability Questionnaire (RMDQ)
Measured: Change from Baseline Disability at 6 weaks
Soleus H-reflex amplitude
by EMG unit
Measured: Change from Baseline Soleus H-reflex amplitude at 6 weaks
Soleus H-reflex side-to-side amplitude (H/H) ratio
by EMG unit
Measured: Change from Baseline Soleus H/H ratio at 6 weaks
Fractional anisotropy (FA) of the compressed nerve root
by MRI examination
Measured: Change from Baseline Fractional anisotropy (FA) ratio at 6 weaks
Apparent diffusion coefficient (ADC) of the compressed nerve root
by MRI examination
Measured: Change from Baseline Apparent diffusion coefficient (ADC) at 6 weaks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Jun 2018
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Badr Hassanein, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058806
- Sponsor's protocol ID
- MBH18
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal Physical Therapy on Pain, Disability, H-reflex, and Diffusion Tensor Imaging Parameters in Patients With Lumbosacral Radiculopathy
- ClinicalTrials.gov ID
- NCT06058806
- Acronym / sponsor ID
- MBH18
- Conditions
- Lumbosacral Radiculopathy
- Keywords
- Lumbosacral Radiculopathy, Lumbar disc herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 28 Sep 2023 (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.
Purposes of the study
To investigate the effect of Multimodal Physical Therapy on pain, daiablility H-reflex, and Diffusion Tensor Imaging (DTI) Parameters in Patients With Lumbosacral Radiculopathy.
Detailed description
Participants will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal Physical Therapy | Experimental | Other: Multimodal Physical TherapyPatients in this group will receive Multimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- chronic (≥ 3 months) unilateral Lumbosacral Radiculopathy (LSR)
- The LSR is due to paracentral L4-L5 or L5-S1 Lumbar disc herniation
- The LSR is confirmed radiologically by MRI
- The LSR is confirmed clinically by history and physical examination
- The LSR is confirmed neurophysiological by soleus H-reflex assessment
Key exclusion criteria (11 listed)
- systematic disease
- Bilateral symptoms
- Lumbar spinal stenosis
- previous surgery
- Steroid injection
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 |
|---|---|---|
| Multimodal Physical TherapyAlso: Physical Therapy, PhysiotherapyMultimodal Physical Therapy program consisting of electrophysical agents, manual therapy interventions, and core stability exercises | Other | Multimodal Physical Therapy |
Primary outcome
Pain
Time frame: Change from Baseline pain at 6 weaks
Visual analog scale (VAS)
Disability
Time frame: Change from Baseline Disability at 6 weaks
Roland-Morris Disability Questionnaire (RMDQ)
Soleus H-reflex amplitude
Time frame: Change from Baseline Soleus H-reflex amplitude at 6 weaks
by EMG unit
Soleus H-reflex side-to-side amplitude (H/H) ratio
Time frame: Change from Baseline Soleus H/H ratio at 6 weaks
by EMG unit
Fractional anisotropy (FA) of the compressed nerve root
Time frame: Change from Baseline Fractional anisotropy (FA) ratio at 6 weaks
by MRI examination
Apparent diffusion coefficient (ADC) of the compressed nerve root
Time frame: Change from Baseline Apparent diffusion coefficient (ADC) at 6 weaks
by MRI examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Physical Therapy in people with Lumbosacral Radiculopathy, run by Cairo University 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 28 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Change from Baseline pain at 6 weaks). The study lists 6 primary outcomes in all. 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 28 Sep 2023.