Tecar Therapy in Patients With Lumbar Radiculopathy

NCT07480252 | Not Yet Recruiting

• 1 other identifier: 2024-KAEK-23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Lumbar Radiculopathy

Keywords

lumbar radiculopathy; Capacitive and Resistive Energy Transfer

Outcome Measures

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.

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

Secondary Outcomes (3)

• Neuropathic Pain Characteristics (PainDETECT Questionnaire)

  Baseline, Week 2, Week 6, and Week 12

• Lumbar Mobility (Modified-Modified Schober Test)

  Baseline, Week 2, Week 6, and Week 12

• Nerve Root Irritability (Straight Leg Raise Test)

  Baseline, Week 2, Week 6, and Week 12

Study Arms (3)

Conventional Physical Therapy

ACTIVE COMPARATOR

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

Tecar Therapy

EXPERIMENTAL

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

Arm Title

SHAM COMPARATOR

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

Interventions

Tecar Therapy DEVICE

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.

Tecar Therapy

Sham Tecar Therapy DEVICE

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.

Arm Title

Conventional Physical Therapy PROCEDURE

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.

Conventional Physical Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Izmir City Hospital: lead

Study Sites (1)

İzmir City Hospital

Çiğli, İzmir, 35000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35147930 BACKGROUND

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ertan Yilmaz, Medical Doctor, Specialist

  Izmir City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ertan Yilmaz, Medical Doctor, Specialist

CONTACT

+905318431901; ertnyilmzz@gmail.com

Ertam Yilmaz, Medical Doctor, Specialist

CONTACT

ertnyilmzz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants allocated to the Tecar therapy and sham Tecar therapy groups were blinded to treatment allocation, as both interventions used identical procedures and a hypothermic electrode head, with the sham device delivering zero energy output. Outcome assessments were performed by an independent physiatrist blinded to group allocation. Blinding of participants and therapists was not possible in the conventional physical therapy group due to the nature of the interventions. Therefore, the trial is designed as an assessor-blinded randomized controlled trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 14, 2026
• First Posted: March 18, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): April 15, 2028
• Study Completion (Estimated): December 15, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)