Thérapie Tecar chez les patients atteints de radiculopathie lombaire : un essai contrôlé randomisé
Efficacité de la Thérapie Tecar par rapport à la Kinésithérapie Conventionnelle et au Traitement Placebo chez les Patients Atteints de Radiculopathie Lombaire : Un Essai Randomisé Contrôlé
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 radicular leg pain intensity measured by the Visual Analog Scale (VAS) at Week 2. Secondary outcomes will include low back pain intensity (VAS), 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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 radicular leg pain intensity from baseline to Week 2, measured by the Visual Analog Scale (VAS). Secondary outcomes will include low back pain intensity (VAS), 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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Ertan Yilmaz, MD
- Numéro de téléphone: +905318431901
- E-mail: ertnyilmzz@gmail.com
Lieux d'étude
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Izmir, Turquie (Türkiye), 35000
- Recrutement
- İzmir City Hospital
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Contact:
- Ertan Yilmaz, MD
- Numéro de téléphone: +905318431901
- E-mail: ertnyilmzz@gmail.com
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Izmir, Turquie (Türkiye)
- Recrutement
- İzmir Cİty Hospital
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Contact:
- Ertan Yilmaz, Medical Doctor, Specialist
- Numéro de téléphone: +905318431901
- E-mail: ertnyilmzz@gmail.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Any 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Conventional Physical Therapy
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. |
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. |
|
Expérimental: Tecar 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. |
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. |
|
Comparateur factice: Arm Title
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. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Radicular Leg Pain Intensity (Visual Analog Scale, VAS)
Délai: Baseline to Week 2
|
Change from baseline to Week 2 in average radicular leg pain over the previous 7 days, measured on a 10-cm VAS (0 = no pain, 10 = worst imaginable pain). |
Baseline to Week 2
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Low Back Pain Intensity (VAS)
Délai: Baseline, Week 2, Week 6, and Week 12
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Average low back pain over the previous 7 days, measured on a 10-cm VAS. |
Baseline, Week 2, Week 6, and Week 12
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Radicular Leg Pain Intensity (VAS) at Follow-up
Délai: Baseline, Week 6, and Week 12
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Average radicular leg pain over the previous 7 days, measured on a 10-cm VAS. |
Baseline, Week 6, and Week 12
|
|
Neuropathic Pain Characteristics (PainDETECT Questionnaire)
Délai: Baseline, Week 2, Week 6, and Week 12
|
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. |
Baseline, Week 2, Week 6, and Week 12
|
|
Functional Disability (Oswestry Disability Index)
Délai: Baseline, Week 2, Week 6, and Week 12
|
ODI version 2.0, percentage score from 0 to 100; higher scores indicate greater disability. |
Baseline, Week 2, Week 6, and Week 12
|
|
Lumbar Mobility (Modified-Modified Schober Test)
Délai: Baseline, Week 2, Week 6, and Week 12
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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. |
Baseline, Week 2, Week 6, and Week 12
|
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Nerve Root Irritability (Straight Leg Raise Test)
Délai: Baseline, Week 2, Week 6, and Week 12
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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. |
Baseline, Week 2, Week 6, and Week 12
|
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Rescue Medication Consumption
Délai: Weeks 1, 2, 6, and 12
|
Total paracetamol intake (mg/week). |
Weeks 1, 2, 6, and 12
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Exercise Adherence
Délai: Weeks 1, 2, 6, and 12
|
Self-reported percentage of target home exercise sessions completed. |
Weeks 1, 2, 6, and 12
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Treatment Credibility and Expectancy
Délai: Baseline
|
Credibility/Expectancy Questionnaire, administered before the first treatment session. |
Baseline
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Perceived Treatment Allocation
Délai: Week 2
|
Participant belief about the treatment received (active, control, or do not know), TECAR and sham groups only. |
Week 2
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ertan Yilmaz, MD, Izmir City Hospital
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2024-KAEK-23
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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.
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