Trials / Not Yet Recruiting
Not Yet RecruitingNCT07480252
Tecar Therapy in Patients With Lumbar Radiculopathy
Efficacy of Tecar Therapy Versus Conventional Physical Therapy and Sham Treatment in Patients With Lumbar Radiculopathy: A Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Izmir City Hospital · Other Government
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| DEVICE | Sham Tecar Therapy | 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. |
| PROCEDURE | Conventional Physical Therapy | 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. |
Timeline
- Start date
- 2026-04-15
- Primary completion
- 2028-04-15
- Completion
- 2028-12-15
- First posted
- 2026-03-18
- Last updated
- 2026-04-16
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07480252. Inclusion in this directory is not an endorsement.