Tecar Therapy in Patients With Lumbar Radiculopathy
ConditionLumbar Radiculopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIzmir City Hospital
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Tecar Therapy
DeviceTecar 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
DeviceSham 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
Procedure/SurgeryConventional 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Conventional Physical TherapyActive comparator 1 intervention
Group B: Tecar TherapyExperimental treatment 1 intervention
Group C: Arm TitleSham comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Baseline, Week 2 (post-treatment), Week 6, and Week 12Secondary outcomes
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.
Time frame
Baseline, Week 2, Week 6, and Week 122
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 123
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 12Sponsors and contacts
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Source ClinicalTrials.gov