Lumbar RadiculopathyNCT06296303
Effect of Pulsed Magnetic Therapy Versus Phonophoresis in Discogenic Lumbar Radiculopathy Patients
A study testing Pulsed electromagnetic therapy, Ultrasound phonophoresis and Conventional physical therapy in people with Lumbar Radiculopathy, run by Cairo University.
Trial summary
Purposes of the study To investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Pulsed electromagnetic therapy, Ultrasound phonophoresis and Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2024to 30 Jun 2024
- 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
- Patient age ranges from 20 -45
- Unilateral chronic lumbosacral radiculopathy
- Intervertebral disc herniation confirmed by MRI
- one of the following :
- H- reflex amplitude side to side difference 0.67 in absence of latency difference.
- H- reflex amplitude side to side difference smaller than 0.5 in p of latency difference.
- 3 - Side to side H- reflex latency difference more than 1 msec. 4- Prolonged H-reflex latency more than 30 msec.
Who cannot join
- Systematic disease
- Lumbar canal stenosis
- Pervious surgeries
- Scoliosis
- Kyphosis
- Spinal fracture
- Bilateral symptoms
- Steroid injection
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Pulsed Magnetic Therapy Versus Phonophoresis on Sciatic Nerve Cross Section Measured by Ultrasonography in Discogenic Lumbar Radiculopathy Patients
Purposes of the study
To investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients
Read the detailed description
Patients will be randomized into either pulsed magnetic therapy group or phonophoresis group. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Pulsed electromagnetic therapy, Ultrasound phonophoresis, Conventional physical therapy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic therapyOther
Pulsed etromagnetic therapy (1000 gauss) on sciatic nerve in gluteal fold. ( 30 min )
Ultrasound phonophoresisOther
Phonophoresis using dexamethasone and topical diclofenac sodium gel on sciatic nerve in subgluteal fold and mid thigh
Conventional physical therapyOther
Conventional physical therapy consisting of
- IF current on lumbar spine. (15 min )
- Hotpack on lumbar spine . (15 min )
- Neurodynamic mobilization .
- Mobilization and manipulation for lumbar spine.
- Exercises
| Study group | Role | What they receive |
|---|---|---|
| Pulsed electromagnetic therapy group | Experimental | Patients in this group will receive Pulsed electromagnetic therapy + Conventional physical therapy Receives: Other: Pulsed electromagnetic therapy; Other: Conventional physical therapy |
| Ultrasound phonophoresis group | Experimental | Patients in this group will receive Ultrasound phonophoresis + Conventional physical therapy Receives: Other: Ultrasound phonophoresis; Other: Conventional physical therapy |
| Control group | Active comparator | Patients in this group will receive Conventional physical therapy Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual analogue scale
Measured: Change from Baseline pain and function at 6 weeks
Disability
Oswestry disability index
Measured: Change from Baseline pain and function at 6 weeks
Sciatic nerve cross sectional area
Diagnostic Ultrasound
Measured: Change from Baseline pain and function at 6 weeks
Secondary outcomes (2)
H-reflex amplitude
by EMG unit
Measured: Change from Baseline pain and function at 6 weeks
H-reflex side-to-side amplitude (H/H) ratio
by EMG unit
Measured: Change from Baseline pain and function at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start3 Mar 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
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
- NCT06296303
- Sponsor's protocol ID
- MBH24
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 6 Mar 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsed Magnetic Therapy Versus Phonophoresis on Sciatic Nerve Cross Section Measured by Ultrasonography in Discogenic Lumbar Radiculopathy Patients
- ClinicalTrials.gov ID
- NCT06296303
- Acronym / sponsor ID
- MBH24
- Conditions
- Lumbar Radiculopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Mar 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 6 Mar 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.
Purposes of the study
To investigate the effect of pulsed magnetic therapy versus phonophoresis in discogenic lumbar radiculopathy patients
Detailed description
Patients will be randomized into either pulsed magnetic therapy group or phonophoresis group. Patients will receive the intervention for six weeks. Outcomes will be assessed at baseline and post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pulsed electromagnetic therapy group | Experimental | Other: Pulsed electromagnetic therapy, Other: Conventional physical therapyPatients in this group will receive Pulsed electromagnetic therapy + Conventional physical therapy |
| Ultrasound phonophoresis group | Experimental | Other: Ultrasound phonophoresis, Other: Conventional physical therapyPatients in this group will receive Ultrasound phonophoresis + Conventional physical therapy |
| Control group | Active comparator | Other: Conventional physical therapyPatients in this group will receive Conventional physical therapy |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patient age ranges from 20 -45
- Unilateral chronic lumbosacral radiculopathy
- Intervertebral disc herniation confirmed by MRI
- one of the following :
- 3 - Side to side H- reflex latency difference more than 1 msec. 4- Prolonged H-reflex latency more than 30 msec.
Key exclusion criteria (8 listed)
- Systematic disease
- Lumbar canal stenosis
- Pervious surgeries
- Scoliosis
- Kyphosis
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 |
|---|---|---|
| Pulsed electromagnetic therapyPulsed etromagnetic therapy (1000 gauss) on sciatic nerve in gluteal fold. ( 30 min ) | Other | Pulsed electromagnetic therapy group |
| Ultrasound phonophoresisPhonophoresis using dexamethasone and topical diclofenac sodium gel on sciatic nerve in subgluteal fold and mid thigh | Other | Ultrasound phonophoresis group |
| Conventional physical therapyConventional physical therapy consisting of 1. IF current on lumbar spine. (15 min ) 2. Hotpack on lumbar spine . (15 min ) 3. Neurodynamic mobilization . 4. Mobilization and manipulation for lumbar spine. 5. Exercises | Other | Control group, Pulsed electromagnetic therapy group, Ultrasound phonophoresis group |
Primary outcome
Pain
Time frame: Change from Baseline pain and function at 6 weeks
Visual analogue scale
Disability
Time frame: Change from Baseline pain and function at 6 weeks
Oswestry disability index
Sciatic nerve cross sectional area
Time frame: Change from Baseline pain and function at 6 weeks
Diagnostic Ultrasound
2 secondary outcomes
H-reflex amplitude
Time frame: Change from Baseline pain and function at 6 weeks
H-reflex side-to-side amplitude (H/H) ratio
Time frame: Change from Baseline pain and function at 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 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.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed electromagnetic therapy, Ultrasound phonophoresis and Conventional physical therapy in people with Lumbar Radiculopathy, run by Cairo University.
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 8 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mohamed Badr Hassanein, MSc (+20 114 225 3884, 10722016464064@pg.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Change from Baseline pain and function at 6 weeks). The study lists 3 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 6 Mar 2024.