An interventional study of Tecar Therapy and Sham Tecar Therapy in Lumbar Radiculopathy, sponsored by Izmir City Hospital. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Izmir City Hospital · Not applicable, Interventional, and Treatment
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.
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.
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.
483 studies on the registry are indexed under Radiculopathy; 145 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 373 interventional studies indexed under Radiculopathy.
Browse Radiculopathy studies →Izmir City Hospital is the lead sponsor of 25 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants 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.
Procedure: Conventional Physical Therapy
Participants 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.
Device: Tecar Therapy
Participants 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.
Device: Sham Tecar Therapy
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 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 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.
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.
Time frame: Baseline, Week 2 (post-treatment), Week 6, and Week 12
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.
Time frame: Baseline, Week 2, Week 6, and Week 12
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.
Time frame: Baseline, Week 2, Week 6, and Week 12
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.
Time frame: Baseline, Week 2, Week 6, and Week 12
Plan to share: 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.
Started Apr 2026 (actual). Primary completion is estimated for Apr 2028, 24 months after the start.
Of 203 non-industry interventional studies with no phase under Radiculopathy, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 24 months is above that.
Counting every sponsor, half of 215 studies reached it within 12 months; a quarter within 5 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Izmir City Hospital