Lumbar Disc Herniation With RadiculopathyNCT07263737
Pulsed Electromagnetic Field Therapy for Neuropathic Pain in Lumbar Disc Herniation
A study testing Pulsed electromagnetic field (PEMF) in people with Lumbar Disc Herniation With Radiculopathy, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study evaluated whether adding pulsed electromagnetic field (PEMF) therapy to conventional physical therapy provides additional benefits for neuropathic pain and disability in patients with lumbar disc herniation (LDH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Disc Herniation With Radiculopathy
- What is being tested?
- Pulsed electromagnetic field (PEMF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Oct 2022to 15 Aug 2023
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Radicular pain and neuropathic symptoms lasting longer than 3 months
- Presence of lumbar disc herniation on lumbar MRI
- Age between 18 and 75 years
- Visual Analog Scale (VAS) ≥ 4
- DN4 ≥ 4
- At least one positive test among Straight Leg Raise Test (SLRT) and femoral stretch test
- Patients without cognitive impairment who are able to follow verbal instructions
Who cannot join
- -• Having undergone an interventional lumbar injection within the last 3 months
- Receiving physical therapy within the last 3 months
- Using medical treatment for neuropathic pain within the last 3 months
- History of lumbar surgery
- Presence of another neurological disorder that could cause neuropathic symptoms
- Cauda equina syndrome
Show all 11Show fewer
- History of malignancy
- Uncontrolled cardiopulmonary disease
- Pregnancy
- Presence of a pacemaker or electronic implant
- Presence of diabetic neuropathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpasa Numune Training and Research Hospital Physical Rehabilitation and Medicine Clinic
Istanbul
About this study
Official title: Effectiveness of Pulsed Electromagnetic Field Therapy on Neuropathic Pain and Disability in Patients With Lumbar Disc Herniation: A Randomized, Double-Blind, Placebo-Controlled Trial
This randomized controlled study evaluated whether adding pulsed electromagnetic field (PEMF) therapy to conventional physical therapy provides additional benefits for neuropathic pain and disability in patients with lumbar disc herniation (LDH).
→ This study randomly assigned patients into groups to compare treatments. It examined whether adding pulsed electromagnetic field (PEMF) therapy to standard physical therapy could give extra improvement in nerve-related pain and daily function in people with a slipped disc in the lower back.
Read more
Fifty-two patients with ≥3 months of radicular and neuropathic symptoms were enrolled and randomly assigned to a treatment group (PEMF + conventional therapy) or a control group (sham PEMF + conventional therapy).
→ Fifty-two patients who had leg pain and nerve-related symptoms for at least three months joined the study. They were randomly placed into either a treatment group (which received PEMF plus regular therapy) or a control group (which received a fake PEMF treatment plus regular therapy).
Both groups received transcutaneous electrical nerve stimulation, hot packs, and a lumbar exercise program for 15 sessions.
→ Both groups also received the same standard treatments: electrical nerve stimulation, hot packs, and a lower-back exercise program for 15 sessions.
Clinical outcomes-including Visual Analog Scale (VAS), pressure pain threshold, Modified Schober test, DN4, PainDetect, Oswestry Disability Index (ODI), and SF-36-were assessed at baseline, post-treatment, and one month after treatment.
→ Several health measures were checked before treatment, right after treatment, and again one month later. These included pain level (VAS), how sensitive the area was to pressure, lower-back flexibility, nerve-pain questionnaires (DN4 and PainDetect), disability level (ODI), and overall quality of life (SF-36).
Forty-six patients completed the study. → A total of 46 patients finished the study.
Both groups showed significant improvements in VAS scores, neuropathic pain questionnaires (DN4, PainDetect), ODI, and several SF-36 subscales (physical functioning, role-physical, and pain), with additional improvements in emotional role and social functioning observed only in the PEMF group.
→ Both groups improved in many areas: pain levels, nerve-pain scores, disability, and some parts of quality of life (such as physical functioning, daily roles, and pain). Only the PEMF group showed extra improvement in emotional well-being and social activities.
However, none of the between-group comparisons demonstrated significant differences.
- However, when the two groups were compared to each other, there were no meaningful differences.
No meaningful changes were found in lumbar flexibility or pressure pain thresholds in either group.
→ Neither group showed important changes in lower-back flexibility or in how much pressure they could tolerate on painful areas.
In conclusion, adding PEMF therapy to conventional physical therapy did not provide additional benefit for neuropathic symptoms, radicular pain, disability, lumbar flexibility, pressure pain threshold, or quality of life in patients with LDH-related neuropathic pain.
→ In summary, adding PEMF therapy to regular physical therapy did not give extra benefits for nerve pain, leg pain, disability, back flexibility, sensitivity to pressure, or quality of life in people with nerve-related pain caused by a slipped disc.
- Being tested
- Pulsed electromagnetic field (PEMF), Sham PEMF
- Keywords
- pulsed electromagnetic field, neuropathic pain, lumbar disck herniation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic field (PEMF)Device
In our study, the device used for PEMA application was the BTL-4000 Smart. The PEMA waves applied to the treatment group were elongated square-wave signals with a frequency of 55.55 Hz and a magnetic flux density of 30 mT. A 60-cm solenoid applicator of the device was used. With this applicator, a 30-minute treatment was delivered to cover the lumbar region.
Sham PEMFDevice
Sham application with the same device
| Study group | Role | What they receive |
|---|---|---|
| Pulsed electromagnetic field (PEMF) and physical therapy | Experimental | The physical therapy protocol was arranged as follows: 20 minutes of hot pack application to the lumbar region, 10 minutes of rest, 20 minutes of conventional transcutaneus electrical nerve stimulation (TENS) applied to the lumbar region and along the radicular pain pathway, followed by another 10 minutes of rest, and finally 30 minutes of magnetic field therapy . One session lasted a total of 90 minutes.
On the first day, patients were thoroughly instructed in a home exercise program that included lumbar isometric strengthening, pelvic tilt exercises, hamstring stretching, and core stabilization exercises. They were asked to perform each exercise twice daily with ten repetitions throughout the physical therapy program.
Patients received one session per day, five days per week, for a total of 15 sessions. Receives: Device: Pulsed electromagnetic field (PEMF) |
| Sham Pulsed electromagnetic field (PEMF) and physical therapy | Sham comparator | The physical therapy protocol was arranged as follows: 20 minutes of hot pack application to the lumbar region, 10 minutes of rest, 20 minutes of conventional transcutaneus electrical nerve stimulation (TENS) applied to the lumbar region and along the radicular pain pathway, followed by another 10 minutes of rest, and finally 30 minutes of sham magnetic field therapy . One session lasted a total of 90 minutes.
On the first day, patients were thoroughly instructed in a home exercise program that included lumbar isometric strengthening, pelvic tilt exercises, hamstring stretching, and core stabilization exercises. They were asked to perform each exercise twice daily with ten repetitions throughout the physical therapy program.
Patients received one session per day, five days per week, for a total of 15 sessions. Receives: Device: Sham PEMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual Analog Scale (VAS): VAS is the most frequently used parameter for measuring pain intensity in low back pain studies. It is a self-reported scale that typically consists of a 10-cm horizontal or vertical line with two verbal descriptors placed at each end to indicate the extremes of pain. Patients are asked to mark the point that best represents their pain. The VAS score is obtained by measuring the distance in centimeters from the starting point to the patient's mark. In our study, VAS was used to assess the pain experienced by patients in the low back and leg regions during the previous week. VAS was evaluated in three different conditions: at rest, during movement, and at night.
Measured: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
PPT
Pressure Pain Threshold (PPT) Measurements with an Algometer:
An algometer is a pressure-measuring device with a 1-cm rounded tip. The sensation of pressure and pain occurs when polymodal nociceptive nerve endings in superficial and deep tissues are stimulated. Algometers are used in clinical studies to measure the pressure pain threshold.
After the measurement points are identified, the rounded tip of the device is placed perpendicular to the surface of the body being examined. Pressure is increased continuously at a rate of approximately 1 kg per second. Patients are instructed to indicate the moment they first feel any pain or discomfort. As soon as they report this sensation, the pressure is stopped and the pressure pain threshold value is read from the device .
In our study, PPTmeasurements obtained with an algometer were used to evaluate the patients' pain sensitivity. The Jtech Commander Algometer was used as the device.
Measured: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
Secondary outcomes (4)
Neuropathic pain
DN4 and PainDetect Questionnaire (PDQ)
Measured: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
Physical examination tests
Straight Leg Raise Test (SLRT), femoral stretch test, and the Modified Schober test
Measured: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
Disability
Oswestry Disability Index (ODI)
Measured: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
Quality of life Short Form-36 (SF-36) questionnaire
The SF-36 questionnaire was developed by Ware as a general assessment tool intended for use in many diseases, evaluating quality of life through physical and mental health parameters.
Measured: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start30 Oct 2022
- Primary completion15 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc Herniation With RadiculopathyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Gunay, MD, Haydarpasa Numune Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263737
- Sponsor's protocol ID
- HNEAH-KAEK 2022/KK/124
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study data are available with the researcher and can be provided to the relevant authorities if required.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pulsed Electromagnetic Field Therapy on Neuropathic Pain and Disability in Patients With Lumbar Disc Herniation: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07263737
- Acronym / sponsor ID
- HNEAH-KAEK 2022/KK/124
- Keywords
- pulsed electromagnetic field, neuropathic pain, lumbar disck herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 4 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.
This randomized controlled study evaluated whether adding pulsed electromagnetic field (PEMF) therapy to conventional physical therapy provides additional benefits for neuropathic pain and disability in patients with lumbar disc herniation (LDH).
→ This study randomly assigned patients into groups to compare treatments. It examined whether adding pulsed electromagnetic field (PEMF) therapy to standard physical therapy could give extra improvement in nerve-related pain and daily function in people with a slipped disc in the lower back.
Fifty-two patients with ≥3 months of radicular and neuropathic symptoms were enrolled and randomly assigned to a treatment group (PEMF + conventional therapy) or a control group (sham PEMF + conventional therapy).
→ Fifty-two patients who had leg pain and nerve-related symptoms for at least three months joined the study. They were randomly placed into either a treatment group (which received PEMF plus regular therapy) or a control group (which received a fake PEMF treatment plus regular therapy).
Both groups received transcutaneous electrical nerve stimulation, hot packs, and a lumbar exercise program for 15 sessions.
→ Both groups also received the same standard treatments: electrical nerve stimulation, hot packs, and a lower-back exercise program for 15 sessions.
Clinical outcomes-including Visual Analog Scale (VAS), pressure pain threshold, Modified Schober test, DN4, PainDetect, Oswestry Disability Index (ODI), and SF-36-were assessed at baseline, post-treatment, and one month after treatment.
→ Several health measures were checked before treatment, right after treatment, and again one month later. These included pain level (VAS), how sensitive the area was to pressure, lower-back flexibility, nerve-pain questionnaires (DN4 and PainDetect), disability level (ODI), and overall quality of life (SF-36).
Forty-six patients completed the study. → A total of 46 patients finished the study.
Both groups showed significant improvements in VAS scores, neuropathic pain questionnaires (DN4, PainDetect), ODI, and several SF-36 subscales (physical functioning, role-physical, and pain), with additional improvements in emotional role and social functioning observed only in the PEMF group.
→ Both groups improved in many areas: pain levels, nerve-pain scores, disability, and some parts of quality of life (such as physical functioning, daily roles, and pain). Only the PEMF group showed extra improvement in emotional well-being and social activities.
However, none of the between-group comparisons demonstrated significant differences.
- However, when the two groups were compared to each other, there were no meaningful differences.
No meaningful changes were found in lumbar flexibility or pressure pain thresholds in either group.
→ Neither group showed important changes in lower-back flexibility or in how much pressure they could tolerate on painful areas.
In conclusion, adding PEMF therapy to conventional physical therapy did not provide additional benefit for neuropathic symptoms, radicular pain, disability, lumbar flexibility, pressure pain threshold, or quality of life in patients with LDH-related neuropathic pain.
→ In summary, adding PEMF therapy to regular physical therapy did not give extra benefits for nerve pain, leg pain, disability, back flexibility, sensitivity to pressure, or quality of life in people with nerve-related pain caused by a slipped disc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsed electromagnetic field (PEMF) and physical therapy | Experimental | Device: Pulsed electromagnetic field (PEMF)The physical therapy protocol was arranged as follows: 20 minutes of hot pack application to the lumbar region, 10 minutes of rest, 20 minutes of conventional transcutaneus electrical nerve stimulation (TENS) applied to the lumbar region and along the radicular pain pathway, followed by another 10 minutes of rest, and finally 30 minutes of magnetic field therapy . One session lasted a total of 90 minutes. On the first day, patients were thoroughly instructed in a home exercise program that included lumbar isometric strengthening, pelvic tilt exercises, hamstring stretching, and core stabilization exercises. They were asked to perform each exercise twice daily with ten repetitions throughout the physical therapy program. Patients received one session per day, five days per week, for a total of 15 sessions. |
| Sham Pulsed electromagnetic field (PEMF) and physical therapy | Sham comparator | Device: Sham PEMFThe physical therapy protocol was arranged as follows: 20 minutes of hot pack application to the lumbar region, 10 minutes of rest, 20 minutes of conventional transcutaneus electrical nerve stimulation (TENS) applied to the lumbar region and along the radicular pain pathway, followed by another 10 minutes of rest, and finally 30 minutes of sham magnetic field therapy . One session lasted a total of 90 minutes. On the first day, patients were thoroughly instructed in a home exercise program that included lumbar isometric strengthening, pelvic tilt exercises, hamstring stretching, and core stabilization exercises. They were asked to perform each exercise twice daily with ten repetitions throughout the physical therapy program. Patients received one session per day, five days per week, for a total of 15 sessions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- • Radicular pain and neuropathic symptoms lasting longer than 3 months
Key exclusion criteria (11 listed)
- -• Having undergone an interventional lumbar injection within the last 3 months
- Receiving physical therapy within the last 3 months
- Using medical treatment for neuropathic pain within the last 3 months
- History of lumbar surgery
- Presence of another neurological disorder that could cause neuropathic symptoms
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 field (PEMF)In our study, the device used for PEMA application was the BTL-4000 Smart. The PEMA waves applied to the treatment group were elongated square-wave signals with a frequency of 55.55 Hz and a magnetic flux density of 30 mT. A 60-cm solenoid applicator of the device was used. With this applicator, a 30-minute treatment was delivered to cover the lumbar region. | Device | Pulsed electromagnetic field (PEMF) and physical therapy |
| Sham PEMFSham application with the same device | Device | Sham Pulsed electromagnetic field (PEMF) and physical therapy |
Primary outcome
VAS
Time frame: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
Visual Analog Scale (VAS): VAS is the most frequently used parameter for measuring pain intensity in low back pain studies. It is a self-reported scale that typically consists of a 10-cm horizontal or vertical line with two verbal descriptors placed at each end to indicate the extremes of pain. Patients are asked to mark the point that best represents their pain. The VAS score is obtained by measuring the distance in centimeters from the starting point to the patient's mark. In our study, VAS was used to assess the pain experienced by patients in the low back and leg regions during the previous week. VAS was evaluated in three different conditions: at rest, during movement, and at night.
PPT
Time frame: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
Pressure Pain Threshold (PPT) Measurements with an Algometer: An algometer is a pressure-measuring device with a 1-cm rounded tip. The sensation of pressure and pain occurs when polymodal nociceptive nerve endings in superficial and deep tissues are stimulated. Algometers are used in clinical studies to measure the pressure pain threshold. After the measurement points are identified, the rounded tip of the device is placed perpendicular to the surface of the body being examined. Pressure is increased continuously at a rate of approximately 1 kg per second. Patients are instructed to indicate the moment they first feel any pain or discomfort. As soon as they report this sensation, the pressure is stopped and the pressure pain threshold value is read from the device . In our study, PPTmeasurements obtained with an algometer were used to evaluate the patients' pain sensitivity. The Jtech Commander Algometer was used as the device.
4 secondary outcomes
Neuropathic pain
Time frame: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
Physical examination tests
Time frame: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
Disability
Time frame: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
Quality of life Short Form-36 (SF-36) questionnaire
Time frame: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.
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 18 Feb 2026.
- Individual participant dataSharing planned: Undecided. The study data are available with the researcher and can be provided to the relevant authorities if required.
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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 Pulsed electromagnetic field (PEMF) in people with Lumbar Disc Herniation With Radiculopathy, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
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 18 Feb 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
VAS (time frame: Patients were evaluated before treatment, at the end of treatment, and at the first month after treatment.). The study lists 2 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 18 Feb 2026.