Back Pain Lower BackNCT07278596
High Intensity Focused Electromagnetic Therapy on Pain and Quality of Life in Patients With Lumbar Disc Prolapse
A study testing High intensity focused electromagnetic therapy (HIFEMT) and Stabilization exercise program in people with Back Pain Lower Back and Magnetic Therapy, run by Middle East University.
Trial summary
Determine whether high intensity focused electromagnetic therapy has a significant effect on pain and quality of life in patients with lumbar disc prolapse. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Back Pain Lower Back, Magnetic Therapy
- What is being tested?
- High intensity focused electromagnetic therapy (HIFEMT) and Stabilization exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A confirmed diagnosis of lumbar disc prolapse by clinical and radiological evaluation.
- Ages between 30 and 60 years.
- A history of low back pain for at least three months.
- A body mass index less than 30 kg/m².
Who cannot join
- History of spinal surgery or recent traumatic spinal injury.
- Severe spinal canal stenosis or progressive neurological deficits.
- Known malignancy, infection, or inflammatory arthritis affecting the spine.
- Presence of implanted metal devices or pacemakers contraindicating electromagnetic therapy.
- Pregnancy or suspected pregnancy.
- Cognitive or psychological disorders that impair communication or ability to follow instructions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mohammed Elhamrawy, Ph.D contact
About this study
Official title: Effect of High Intensity Focused Electromagnetic Therapy on Pain and Quality of Life in Patients With Lumbar Disc Prolapse: a Randomized Controlled Trial
Determine whether high intensity focused electromagnetic therapy has a significant effect on pain and quality of life in patients with lumbar disc prolapse.
Read the detailed description
Lumbar disc prolapse is a common cause of lower back pain and radiculopathy, frequently affecting individuals in their productive years. It results from displacement of the intervertebral disc material beyond the disc space, leading to nerve root compression and significant pain, disability, and decreased quality of life. Persistent pain and reduced physical function can impair daily activities and may lead to psychological distress. Traditional conservative management, such as physical therapy and pharmacological interventions, may not always provide sufficient relief. High intensity focused electromagnetic therapy is a non-invasive modality that uses electromagnetic fields to stimulate deep muscle contractions. It has shown potential in enhancing muscle strength, modulating pain, and improving functional outcomes in musculoskeletal conditions. However, its role in managing lumbar disc prolapse has not been thoroughly investigated.
- Conditions
- Back Pain Lower Back, Magnetic Therapy
- Being tested
- High intensity focused electromagnetic therapy (HIFEMT), Stabilization exercise program
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity focused electromagnetic therapy (HIFEMT)Other
The patient will be positioned in a comfortable supine or seated position depending on the targeted lumbar area. The applicator will be placed over the lumbar spine, delivering focused electromagnetic pulses to stimulate deep core and paraspinal muscles. Each session will last 30 minutes, conducted three times per week over a period of 8 weeks. The intensity will be progressively adjusted according to patient tolerance, aiming to induce visible supramaximal muscle contractions without discomfort. HIFEMT is intended to promote muscle strengthening, pain modulation, and spinal stabilization.
Stabilization exercise programOther
Participants will be guided through core-strengthening exercises aimed at improving trunk stability, posture, and neuromuscular control. The exercises will include pelvic tilts, bridging, and bird-dog exercises. All sessions will be conducted under supervision of a physiotherapist. Each session will last for approximately 30 minutes, three times weekly for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High intensity focused electromagnetic therapy group | Active comparator | Participants in the study group will receive HIFEMT sessions using the HIFEMT device (Emsculpt Neo, BTL Industries, Boston, MA) twice weekly for 8 weeks. Receives: Other: High intensity focused electromagnetic therapy (HIFEMT); Other: Stabilization exercise program |
| Control group | Active comparator | Stabilization Exercise Program:
Both the study and control groups will receive lumbar stabilization exercise program three times weekly for 8 weeks. Receives: Other: Stabilization exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Back pain
Using the Arabic Numerical Pain Rating Scale (NPRS) to evaluate the intensity of pain at baseline and post-intervention
Measured: Baseline and after 8 weeks
Secondary outcomes (1)
Quality of life assessment
Using the Short Form 12 Health Survey (SF-12) to evaluate both physical and mental health components of quality of life
Measured: Baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start7 Dec 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Lower BackStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Middle East University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saher Lotfy El Gayar, Kasr El Aini Hospital
- Investigators
- Mohamed Sayed Saif, Study director, National institute for Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278596
- Sponsor's protocol ID
- Electromagnetic Therapy
- Status last verified
- Dec 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Focused Electromagnetic Therapy on Pain and Quality of Life in Patients With Lumbar Disc Prolapse: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07278596
- Acronym / sponsor ID
- Electromagnetic Therapy
- Conditions
- Back Pain Lower Back, Magnetic Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Middle East UniversityUniversity, hospital or other
- Study start
- 7 Dec 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 12 Dec 2025 (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.
Determine whether high intensity focused electromagnetic therapy has a significant effect on pain and quality of life in patients with lumbar disc prolapse.
Detailed description
Lumbar disc prolapse is a common cause of lower back pain and radiculopathy, frequently affecting individuals in their productive years. It results from displacement of the intervertebral disc material beyond the disc space, leading to nerve root compression and significant pain, disability, and decreased quality of life. Persistent pain and reduced physical function can impair daily activities and may lead to psychological distress. Traditional conservative management, such as physical therapy and pharmacological interventions, may not always provide sufficient relief. High intensity focused electromagnetic therapy is a non-invasive modality that uses electromagnetic fields to stimulate deep muscle contractions. It has shown potential in enhancing muscle strength, modulating pain, and improving functional outcomes in musculoskeletal conditions. However, its role in managing lumbar disc prolapse has not been thoroughly investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity focused electromagnetic therapy group | Active comparator | Other: High intensity focused electromagnetic therapy (HIFEMT), Other: Stabilization exercise programParticipants in the study group will receive HIFEMT sessions using the HIFEMT device (Emsculpt Neo, BTL Industries, Boston, MA) twice weekly for 8 weeks. |
| Control group | Active comparator | Other: Stabilization exercise programStabilization Exercise Program: Both the study and control groups will receive lumbar stabilization exercise program three times weekly for 8 weeks. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A confirmed diagnosis of lumbar disc prolapse by clinical and radiological evaluation.
- Ages between 30 and 60 years.
- A history of low back pain for at least three months.
- A body mass index less than 30 kg/m².
Key exclusion criteria (6 listed)
- History of spinal surgery or recent traumatic spinal injury.
- Severe spinal canal stenosis or progressive neurological deficits.
- Known malignancy, infection, or inflammatory arthritis affecting the spine.
- Presence of implanted metal devices or pacemakers contraindicating electromagnetic therapy.
- Pregnancy or suspected pregnancy.
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 |
|---|---|---|
| High intensity focused electromagnetic therapy (HIFEMT)The patient will be positioned in a comfortable supine or seated position depending on the targeted lumbar area. The applicator will be placed over the lumbar spine, delivering focused electromagnetic pulses to stimulate deep core and paraspinal muscles. Each session will last 30 minutes, conducted three times per week over a period of 8 weeks. The intensity will be progressively adjusted according to patient tolerance, aiming to induce visible supramaximal muscle contractions without discomfort. HIFEMT is intended to promote muscle strengthening, pain modulation, and spinal stabilization. | Other | High intensity focused electromagnetic therapy group |
| Stabilization exercise programParticipants will be guided through core-strengthening exercises aimed at improving trunk stability, posture, and neuromuscular control. The exercises will include pelvic tilts, bridging, and bird-dog exercises. All sessions will be conducted under supervision of a physiotherapist. Each session will last for approximately 30 minutes, three times weekly for 8 weeks. | Other | Control group, High intensity focused electromagnetic therapy group |
Primary outcome
Back pain
Time frame: Baseline and after 8 weeks
Using the Arabic Numerical Pain Rating Scale (NPRS) to evaluate the intensity of pain at baseline and post-intervention
1 secondary outcome
Quality of life assessment
Time frame: Baseline and after 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- 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.
Mohammed Elhamrawy, Ph.D contact
Mohamed Sayed Saif study director
National institute for Gerontology
Questions about this trial
What is this clinical trial studying?
A study testing High intensity focused electromagnetic therapy (HIFEMT) and Stabilization exercise program in people with Back Pain Lower Back and Magnetic Therapy, run by Middle East 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 4 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: opening soon, as of the sponsor's last update on 12 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saher Elgayar, Ph.D (+201020429911, saherlotfy020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain (time frame: Baseline and after 8 weeks). 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 12 Dec 2025.