Lumbar Disc HerniationNCT05559723
Effect of Electromagnetic Field in Lumbar Disc Prolapse Patients
A study testing electromagnetic field therapy, selected physical therapy program and Therapeutic ultrasound therapy in people with Lumbar Disc Herniation, run by October 6 University at 1 site in Egypt.
Trial summary
to investigate the effect of electromagnetic field therapy on sciatica and postural control in lumbar disc prolapse patients BACKGROUND: lumbar disc prolapse is a clinical condition resulting from compression of lumbar nerve roots resulting in decreased postural control and alleviating sciatic pain Pulsed… Read more about this study
- Who is it for?
- Ages 30 to 45 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- electromagnetic field therapy, selected physical therapy program and Therapeutic ultrasound therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2023to 30 Jan 2025
- 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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranging from 30:45
- sciatica due to lumbar disc prolapse mild to moderate disc prolapse according to magnetic resonance image (MRI).
- Body mass index (18.5 to 29.9) Kg/m2.
Who cannot join
- The patients will be excluded if they have one of the followings:
- lumbar myelopathy.
- Patients with previous spinal surgery.
- Inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis
- Any other neurological or musculoskeletal disorders of the spine or upper extremity.
- Patient with cardiopulmonary disease or diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Electromagnetic Field Therapy on Sciatica and Postural Control in Lumbar Disc Prolapse Patients
to investigate the effect of electromagnetic field therapy on sciatica and postural control in lumbar disc prolapse patients BACKGROUND: lumbar disc prolapse is a clinical condition resulting from compression of lumbar nerve roots resulting in decreased postural control and alleviating sciatic pain Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders
Read the detailed description
Thirty-four patients with lumbar disc prolapse The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. The evaluation methods by Visual analogue scale for pain (VAS-P), ) multidirectional reach test, McGill pain Questionnaire, time up and go test and Oswestry Low Back Pain Disability Questionnaire
- Conditions
- Lumbar Disc Herniation
- Being tested
- electromagnetic field therapy, selected physical therapy program, Therapeutic ultrasound therapy, Transcutaneous Electrical Nerve Stimulation
- 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.
electromagnetic field therapyDevice
Three times a week for four weeks, the study group got electromagnetic fields (EMFs) therapy and the selected physical therapy program. The EMFs therapy was applied using an electromagnetic field therapy device (Magner Plus Astar)
. From the prone lying position the device will be adjusted around the lumbar area at a low frequency (50 Hz), with the intensity of 2.5 MT, field shape and applicator type rectangular csl60/csp60), and the application time will be10 minutes
selected physical therapy programOther
in the form of
- Hot packs will be placed paravertebral on the lumbar region for 5 minutes from a prone lying position
- selected physical therapy exercises in form of Static exercise for back and abdominal muscles, stretching exercises for both lower limbs, 10 times each exercise
Therapeutic ultrasound therapyDevice
Therapeutic ultrasound therapy using ultrasound device Chattanooga, model 2760, serial number T11238, 120-240V, 50/60Hz, made in Mexico . That will be applied paravertebral on the lumbar region from the prone lying position, with pulsed mode, frequency 1 MHz, intensity 0.5 W/cm2 and will be applied by circular moving technique at a rate of 4 cm/s for 10 minutes.
Transcutaneous Electrical Nerve StimulationDevice
Transcutaneous Electrical Nerve Stimulation (TENS): from the prone lying position, the electrodes will be placed on the course of pain detected by the patient, with an asymmetrical rectangular biphasic form, at a pulse repetition frequency of 100Hz and duty cycle of 250 microseconds; the intensity was set at a level that each patient could feel, for 15 minutes .
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | electromagnetic field therapy Receives: Device: electromagnetic field therapy; Other: selected physical therapy program; Device: Therapeutic ultrasound therapy; Device: Transcutaneous Electrical Nerve Stimulation |
| control group | Experimental | the selected exercise program Receives: Other: selected physical therapy program; Device: Therapeutic ultrasound therapy; Device: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
which assesses pain on a paper sheet scale with an increasing number from 0 (no pain) to 10 (the worst pain imaginable).
Measured: 4 weeks
Multi-Directional Reach test
Multi-Directional Reach test (MDRT) is an assessment method used to evaluate the limits of stability of individuals in four directions "forward, backward, right and left".
The normal Scores of the multi-directional reach test for individuals with age ranging from (20 to 39 cm) years are as follow: forward reach (28 cm); backward reach (17 to 18 cm); leftward reach (17 to 21 cm) and rightward reach (18 to 20 cm)
Measured: 4 weeks
time up and go test
To determine fall risk and measure the progress of balance, sit to stand and walking.
Simple screening test that is a sensitive and specific measure of probability for falls among older adults An older adult who takes ≥12 seconds to complete the TUG is at risk for falling
Measured: 4 weeks
Oswestry Low Back Pain Disability Questionnaire
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. I
Measured: 4 weeks
Secondary outcomes (1)
The McGill Pain Questionnaire
The McGill Pain Questionnaire (MPQ) is a self-reporting measure of pain used for patients with a number of diagnoses. It assesses both quality and intensity of subjective pain. The MPQ is a multi-dimesional tool for pain assessment and it has three components, which are the sensory intensity, the cognitive evaluation of pain and the emotional impact of pain
The MPQ is composed of 78 words, of which respondents choose those that best describe their experience of pain. Seven words are selected from the following categories: dimension 1 to 10 (pain descriptors), three words; dimensions 11 to 15 (affective components of pain), dimension 16 (evaluation of pain) one word, and dimension 17 to 20 (miscellaneous) one word. Scores are tabulated by summing values associated with each word; scores range from 0 (no pain) to 78 (severe pain). Qualitative differences in pain may be reflected in respondent's word choice
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start25 Jan 2023
- Primary completion30 May 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Saad El-Din Mahmoud, October 6 University
- Investigators
- Lama Saad El-Din Mahmoud, PHD, Study chair, October 6 UniversityKEROLOS AWAD HABIB SAEED, masters, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559723
- Sponsor's protocol ID
- P.T. REC/012/004099
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electromagnetic Field Therapy on Sciatica and Postural Control in Lumbar Disc Prolapse Patients
- ClinicalTrials.gov ID
- NCT05559723
- Acronym / sponsor ID
- P.T. REC/012/004099
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 29 Sep 2022 (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.
to investigate the effect of electromagnetic field therapy on sciatica and postural control in lumbar disc prolapse patients BACKGROUND: lumbar disc prolapse is a clinical condition resulting from compression of lumbar nerve roots resulting in decreased postural control and alleviating sciatic pain Pulsed electromagnetic field (PEMF) therapy is an easy, non-invasive, safe, and relatively new treatment method that is used with growing interest in physical and rehabilitation medicine. Historically, the benefits from magnetotherapy have been reported for patients with musculoskeletal and neurological disorders
Detailed description
Thirty-four patients with lumbar disc prolapse The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to electromagnetic field therapy, three times per week for four weeks. The evaluation methods by Visual analogue scale for pain (VAS-P), ) multidirectional reach test, McGill pain Questionnaire, time up and go test and Oswestry Low Back Pain Disability Questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: electromagnetic field therapy, Other: selected physical therapy program, Device: Therapeutic ultrasound therapy, Device: Transcutaneous Electrical Nerve Stimulationelectromagnetic field therapy |
| control group | Experimental | Other: selected physical therapy program, Device: Therapeutic ultrasound therapy, Device: Transcutaneous Electrical Nerve Stimulationthe selected exercise program |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ranging from 30:45
- sciatica due to lumbar disc prolapse mild to moderate disc prolapse according to magnetic resonance image (MRI).
- Body mass index (18.5 to 29.9) Kg/m2.
Key exclusion criteria (6 listed)
- The patients will be excluded if they have one of the followings:
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 |
|---|---|---|
| electromagnetic field therapyThree times a week for four weeks, the study group got electromagnetic fields (EMFs) therapy and the selected physical therapy program. The EMFs therapy was applied using an electromagnetic field therapy device (Magner Plus Astar) . From the prone lying position the device will be adjusted around the lumbar area at a low frequency (50 Hz), with the intensity of 2.5 MT, field shape and applicator type rectangular csl60/csp60), and the application time will be10 minutes | Device | study group |
| selected physical therapy programin the form of 1. Hot packs will be placed paravertebral on the lumbar region for 5 minutes from a prone lying position 2. selected physical therapy exercises in form of Static exercise for back and abdominal muscles, stretching exercises for both lower limbs, 10 times each exercise | Other | control group, study group |
| Therapeutic ultrasound therapyTherapeutic ultrasound therapy using ultrasound device Chattanooga, model 2760, serial number T11238, 120-240V, 50/60Hz, made in Mexico . That will be applied paravertebral on the lumbar region from the prone lying position, with pulsed mode, frequency 1 MHz, intensity 0.5 W/cm2 and will be applied by circular moving technique at a rate of 4 cm/s for 10 minutes. | Device | control group, study group |
| Transcutaneous Electrical Nerve StimulationTranscutaneous Electrical Nerve Stimulation (TENS): from the prone lying position, the electrodes will be placed on the course of pain detected by the patient, with an asymmetrical rectangular biphasic form, at a pulse repetition frequency of 100Hz and duty cycle of 250 microseconds; the intensity was set at a level that each patient could feel, for 15 minutes . | Device | control group, study group |
Primary outcome
visual analogue scale
Time frame: 4 weeks
which assesses pain on a paper sheet scale with an increasing number from 0 (no pain) to 10 (the worst pain imaginable).
Multi-Directional Reach test
Time frame: 4 weeks
Multi-Directional Reach test (MDRT) is an assessment method used to evaluate the limits of stability of individuals in four directions "forward, backward, right and left". The normal Scores of the multi-directional reach test for individuals with age ranging from (20 to 39 cm) years are as follow: forward reach (28 cm); backward reach (17 to 18 cm); leftward reach (17 to 21 cm) and rightward reach (18 to 20 cm)
time up and go test
Time frame: 4 weeks
To determine fall risk and measure the progress of balance, sit to stand and walking. Simple screening test that is a sensitive and specific measure of probability for falls among older adults An older adult who takes ≥12 seconds to complete the TUG is at risk for falling
Oswestry Low Back Pain Disability Questionnaire
Time frame: 4 weeks
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. I
1 secondary outcome
The McGill Pain Questionnaire
Time frame: four weeks
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 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Lama Saad El-Din Mahmoud, PHD study chair
October 6 University
KEROLOS AWAD HABIB SAEED, masters principal investigator
October 6 University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electromagnetic field therapy, selected physical therapy program and Therapeutic ultrasound therapy in people with Lumbar Disc Herniation, run by October 6 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 3 inclusion and 6 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 14 Oct 2026. 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?
visual analogue scale (time frame: 4 weeks). The study lists 4 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 14 Oct 2026.