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Lumbar RadiculopathyNCT07480252

Tecar Therapy in Patients With Lumbar Radiculopathy

A study testing Tecar Therapy and Conventional Physical Therapy in people with Lumbar Radiculopathy, run by Izmir City Hospital at 2 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Lumbar radiculopathy is a common cause of low back and leg pain, most frequently resulting from lumbar disc herniation and nerve root irritation. Conservative management, including physical therapy modalities and exercise therapy, is generally recommended as first-line treatment for patients without progressive… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lumbar Radiculopathy
What is being tested?
Tecar Therapy and Conventional Physical Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
2 sitesTurkey (Türkiye)
Study dates
15 Apr 2026to 15 Dec 2028
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18-65 years
  • Clinical diagnosis of unilateral L5 and/or S1 lumbar radiculopathy
  • Symptom duration between 6 weeks and 6 months
  • Average radicular pain intensity ≥3 on the Visual Analog Scale (VAS) during the previous month
  • Availability of lumbar MRI and/or EMG performed within the previous 6 months
  • Willingness to participate and ability to provide written informed consent

Who cannot join

  • Bilateral lumbar radiculopathy
  • Lumbar spinal canal stenosis confirmed by imaging or suspected clinically (e.g., neurogenic claudication)
  • Lower limb muscle strength <4/5 according to the Medical Research Council (MRC) scale
  • Use of analgesic medications other than paracetamol during the study period
  • Physical therapy treatment for low back or radicular pain within the past 3 months
  • Contraindications to physical therapy modalities or Tecar therapy
Show all 10Show fewer
  • Previous lumbar spine surgery or interventional spinal procedures within the last 6 months
  • Pregnancy, malignancy, or systemic neurological or rheumatologic disease
  • Advanced spinal or lower extremity deformities (e.g., scoliosis >20°, grade 3-4 spondylolisthesis, vertebral fracture, advanced coxarthrosis)
  • Inability to complete the intervention protocol or follow-up assessments

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ertan Yilmaz, MD contact

+905318431901

ertnyilmzz@gmail.com

Turkey (Türkiye)2 sites, 2 recruiting
  • İzmir City Hospital

    Izmir, İzmir, 35000

    Ertan Yilmaz, MD, +905318431901, ertnyilmzz@gmail.com

    Recruiting
  • İzmir Cİty Hospital

    Izmir, İzmir

    Ertan Yilmaz, Medical Doctor, Specialist, +905318431901, ertnyilmzz@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Efficacy of Tecar Therapy Versus Conventional Physical Therapy and Sham Treatment in Patients With Lumbar Radiculopathy: A Randomized Controlled Trial

Lumbar radiculopathy is a common cause of low back and leg pain, most frequently resulting from lumbar disc herniation and nerve root irritation. Conservative management, including physical therapy modalities and exercise therapy, is generally recommended as first-line treatment for patients without progressive neurological deficits. Tecar therapy (Transfer of Energy Capacitive and Resistive) is a non-invasive electrotherapeutic modality that delivers high-frequency electromagnetic energy to deep tissues and has been proposed to reduce pain, enhance microcirculation, and promote tissue recovery. However, evidence regarding its effectiveness in lumbar radiculopathy remains limited.

The aim of this randomized controlled trial is to evaluate the efficacy of Tecar therapy in patients with lumbar radiculopathy and to compare its clinical effects with conventional physical therapy and sham Tecar treatment.

Read more

A total of 90 participants with unilateral L5 and/or S1 radiculopathy will be randomized into three groups: (1) conventional physical therapy, (2) Tecar therapy combined with standard physical therapy, and (3) sham Tecar therapy combined with standard physical therapy. All participants will receive standardized postural education and a home exercise program.

The primary outcome will be pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes will include functional disability (Oswestry Disability Index), neuropathic pain characteristics (PainDETECT questionnaire), lumbar mobility (Modified-Modified Schober Test), nerve root irritability (Straight Leg Raise test), rescue analgesic consumption, and exercise adherence. Outcomes will be assessed at baseline, post-treatment (week 2), and follow-up visits at weeks 6 and 12.

Read the detailed description

This assessor-blinded, randomized controlled trial will be conducted in the Department of Physical Medicine and Rehabilitation at İzmir City Hospital, a tertiary-level outpatient center. The study will be designed and reported according to CONSORT recommendations.

Participants aged 18-65 years with clinically diagnosed unilateral L5 and/or S1 radiculopathy and symptom duration between 6 weeks and 6 months will be eligible. Diagnosis will primarily be based on clinical findings consistent with radiculopathy, including dermatomal leg pain and supportive neurological examination findings, while lumbar MRI and/or EMG will be used as confirmatory evidence. After written informed consent is obtained, eligible participants will be randomly assigned in a 1:1:1 ratio to one of three groups using computer-generated randomization with concealed allocation.

Group 1 will receive conventional physical therapy consisting of hot pack, continuous ultrasound therapy, and transcutaneous electrical nerve stimulation (TENS). Group 2 will receive Tecar therapy in addition to standardized base therapy. Tecar treatment will include capacitive and resistive energy transfer applied to the lumbar paraspinal region and gluteal muscles. Group 3 will receive sham Tecar therapy using the same procedure as the active Tecar protocol but with zero energy output. All groups will additionally receive standardized postural education and a home exercise program.

Outcome assessments will be performed by an independent physiatrist blinded to group allocation at four time points: baseline, post-treatment (week 2), and follow-up visits at weeks 6 and 12. The primary outcome will be change in pain intensity measured by the Visual Analog Scale (VAS). Secondary outcomes will include functional disability (Oswestry Disability Index), neuropathic pain features (PainDETECT questionnaire), lumbar mobility (Modified-Modified Schober Test), nerve root irritability assessed with the Straight Leg Raise test, rescue analgesic consumption, and exercise adherence.

The study aims to determine whether Tecar therapy provides additional clinical benefit over conventional physical therapy and to evaluate the effectiveness of Tecar therapy beyond placebo effects using a sham-controlled design.

Being tested
Tecar Therapy, Sham Tecar Therapy, Conventional Physical Therapy
Keywords
lumbar radiculopathy, Capacitive and Resistive Energy Transfer
Medical subject headings
Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tecar TherapyDevice

    Tecar therapy (Transfer of Energy Capacitive and Resistive) will be applied using capacitive and resistive modes to the lumbar paraspinal region and gluteal muscles. Energy output will be adjusted to approximately 50-70% of the device capacity to achieve a comfortably warm sensation. Each session will last approximately 25 minutes and will be performed three times per week for two weeks. All applications will be delivered using a hypothermic electrode head.

  • Sham Tecar TherapyDevice

    Sham Tecar therapy will be delivered using the same device, electrode head, treatment duration, and therapist contact as the active Tecar therapy protocol. However, the device will be set to zero intensity output, preventing the delivery of electromagnetic energy or heat. This procedure is designed to mimic the active intervention while providing no therapeutic effect.

  • Conventional Physical TherapyProcedure or surgery

    Conventional physical therapy will include a combination of hot pack, continuous ultrasound therapy, and transcutaneous electrical nerve stimulation (TENS) applied to the lumbar region. Treatment sessions will be conducted five times per week for two weeks. Participants will also receive standardized postural education and a home exercise program.

Study groups in NCT07480252
Study groupRoleWhat they receive
Conventional Physical TherapyActive comparatorParticipants in this group will receive conventional physical therapy consisting of hot pack, continuous ultrasound therapy, and transcutaneous electrical nerve stimulation (TENS) applied to the lumbar region. Treatments will be administered five times per week for two weeks (10 sessions). Participants will also receive standardized postural education and a home exercise program.
Receives: Procedure: Conventional Physical Therapy
Tecar TherapyExperimentalParticipants in this group will receive Tecar therapy in addition to standardized base physical therapy consisting of hot pack and TENS. Tecar therapy will be applied to the lumbar paraspinal region and gluteal muscles using capacitive and resistive modes with adjustable energy output. Sessions will be performed three times per week for two weeks. Participants will also receive standardized postural education and a home exercise program.
Receives: Device: Tecar Therapy
Arm TitleSham comparatorParticipants in this group will receive sham Tecar therapy in addition to standardized base physical therapy consisting of hot pack and TENS. The sham procedure will follow the same protocol as the active Tecar therapy, including identical electrode contact and treatment duration, but the device will be set to zero energy output, preventing any thermal or electrical effect. Participants will also receive standardized postural education and a home exercise program.
Receives: Device: Sham Tecar Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Intensity (Visual Analog Scale, VAS)

    Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents "no pain" and 10 represents "worst imaginable pain." Participants will rate their average lumbar and radicular pain intensity during the previous 7 days.

    Measured: Baseline, Week 2 (post-treatment), Week 6, and Week 12

Secondary outcomes (3)
  1. Neuropathic Pain Characteristics (PainDETECT Questionnaire)

    Neuropathic pain features will be assessed using the PainDETECT Questionnaire, a validated self-report instrument ranging from -1 to 38 points. Higher scores indicate a greater likelihood of neuropathic pain components.

    Measured: Baseline, Week 2, Week 6, and Week 12

  2. Lumbar Mobility (Modified-Modified Schober Test)

    Lumbar spine mobility will be assessed using the Modified-Modified Schober Test. The distance between two skin marks placed over the lumbar spine will be measured during maximal forward flexion.

    Measured: Baseline, Week 2, Week 6, and Week 12

  3. Nerve Root Irritability (Straight Leg Raise Test)

    The Straight Leg Raise (SLR) test will be used to assess nerve root irritability. The angle at which radicular pain is reproduced during passive leg elevation will be measured using a goniometer.

    Measured: Baseline, Week 2, Week 6, and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2026
  2. Study start15 Apr 2026
  3. Primary completion15 Apr 2028 (estimated)
  4. Study completion15 Dec 2028 (estimated)

Resources

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
Model description
Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: conventional physical therapy, Tecar therapy combined with standardized physical therapy, or sham Tecar therapy combined with standardized physical therapy. All groups will receive standardized postural education and a home exercise program. The study follows a parallel-group design in which participants remain in their assigned intervention group throughout the study perio
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07480252
Sponsor's protocol ID
2024-KAEK-23
Status last verified
Oct 2026
First submitted
14 Mar 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly shared due to institutional data protection policies and privacy regulations. Only aggregated data will be reported in scientific publications.

Publications

  • Barassi G, Mariani C, Supplizi M, Prosperi L, Di Simone E, Marinucci C, Pellegrino R, Guglielmi V, Younes A, Di Iorio A. Capacitive and Resistive Electric Transfer Therapy: A Comparison of Operating Methods in Non-specific Chronic Low Back Pain. Adv Exp Med Biol. 2022;1375:39-46. doi: 10.1007/5584_2021_692.

    PubMed 35147930

Questions about this trial

What is this clinical trial studying?

A study testing Tecar Therapy and Conventional Physical Therapy in people with Lumbar Radiculopathy, run by Izmir City Hospital at 2 sites 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 6 inclusion and 10 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: looking for participants now, 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 2 sites 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?

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 Ertan Yilmaz, MD (+905318431901, ertnyilmzz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (Visual Analog Scale, VAS) (time frame: Baseline, Week 2 (post-treatment), Week 6, and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07480252, which also lists 1 linked publication.

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.

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