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High-Intensity Laser Therapy Versus Transforaminal Epidural Steroid Injection in Chronic Lumbar Disc Herniation-Related Low Back and Radicular Pain

30 giugno 2026 aggiornato da: Esra Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent

Comparison of the Effectiveness of High-Intensity Laser Therapy and Transforaminal Epidural Steroid Injection in Patients With Chronic Axial and Radicular Low Back Pain Due to Lumbar Disc Herniation: A Prospective Randomized Controlled Trial

This prospective, randomized, single-blinded, controlled clinical trial aims to compare the effectiveness of high-intensity laser therapy and fluoroscopy-guided transforaminal epidural steroid injection in patients with chronic low back pain and lumbar radiculopathy. Eligible patients will be randomized into two parallel groups. One group will receive high-intensity laser therapy, and the other group will receive transforaminal epidural steroid injection. All participants will also receive a standardized home-based exercise program. Outcomes will be assessed at baseline, 2 weeks, 6 weeks, and 12 weeks after treatment. The primary outcome will be pain intensity measured by the Visual Analog Scale. Secondary outcomes will include functional disability, neuropathic pain symptoms, quality of life, and functional walking capacity.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Low back pain is one of the most common musculoskeletal complaints and may lead to substantial disability and reduced quality of life. Lumbar disc herniation is a frequent cause of chronic axial and radicular low back pain.

High-intensity laser therapy is a non-invasive physical therapy modality with analgesic, anti-inflammatory, and biostimulatory effects. Transforaminal epidural steroid injection is a minimally invasive interventional treatment commonly used for radicular pain associated with lumbar disc herniation.

This prospective randomized controlled trial will include adult patients aged 18 to 65 years with chronic axial and radicular low back pain due to lumbar disc herniation. Participants will be randomized into two parallel groups. One group will receive high-intensity laser therapy for 15 sessions over 3 weeks, and the other group will receive fluoroscopy-guided transforaminal epidural steroid injection. All participants will receive a standardized home-based exercise program. Outcomes will be assessed at baseline, 2 weeks, 6 weeks, and 12 weeks after treatment.

Tipo di studio

Interventistico

Iscrizione (Stimato)

24

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Esra Ülgen Kıratlıoğlu, MD
  • Numero di telefono: +905079614194
  • Email: esraulgen@gmail.com

Luoghi di studio

  • Turchia (Türkiye)
      • Ankara, Turchia (Türkiye)
        • Reclutamento
        • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age between 18 and 65 years
  • Diagnosis of lumbar disc herniation confirmed by clinical examination and lumbar magnetic resonance imaging
  • Chronic axial low back pain and radicular pain related to lumbar disc herniation
  • Low back and/or radicular pain lasting longer than 3 months
  • Resting low back and/or radicular pain intensity of ≥5 on a 0-10 visual analog scale
  • Willingness to participate in the study and provide written informed consent

Exclusion Criteria:

  • Pregnancy or suspected pregnancy
  • Presence of a cardiac pacemaker
  • History of epilepsy
  • Active or previous malignancy
  • History of spinal surgery
  • Uncontrolled systemic or psychiatric disease
  • Cauda equina syndrome or progressive neurological deficit
  • Peripheral neuropathy, including diabetic or alcohol-related neuropathy
  • Neurodegenerative disease
  • Acute trauma
  • Active systemic infection
  • Local infection or skin disease at the injection site or treatment area
  • Body mass index greater than 40 kg/m²
  • Bleeding disorder that contraindicates treatment
  • Spinal stenosis, spondylolysis, or spondylolisthesis
  • Neurogenic bladder or bowel syndrome
  • Rheumatologic disease
  • Arterial vascular disease or vascular claudication
  • Receipt of other physical therapy modalities within the last 3 months
  • Receipt of spinal injection therapy within the last 3 months
  • History of allergy to injection agents

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: High-Intensity Laser Therapy
Participants in this group will receive high-intensity laser therapy using a pulsed Nd:YAG laser device for 15 sessions over 3 weeks. Treatment will be applied to the lumbar paravertebral region using the lumbosciatalgia mode. All participants will also receive a home exercise program.
Dispositivo: High-Intensity Laser Therapy
High-intensity laser therapy will be applied using a pulsed Nd:YAG laser with a wavelength of 1064 nm. Treatment will be delivered in 15 sessions over 3 weeks to the lumbar paravertebral region. Each session will last approximately 10-12 minutes with a total energy dose of 2500 joules.
Comparatore attivo: Transforaminal Epidural Steroid Injection
Participants in this group will receive fluoroscopy-guided transforaminal epidural steroid injection. The injection level will be determined according to physical examination and lumbar magnetic resonance imaging findings. All participants will also receive a home exercise program.
Procedura: Transforaminal Epidural Steroid Injections
Fluoroscopy-guided transforaminal epidural steroid injection will be performed by an experienced physical medicine and rehabilitation specialist. After confirmation of needle placement with contrast medium, 2 mL of 2% lidocaine hydrochloride and 8 mg/2 mL dexamethasone will be administered.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Low Back and Leg Pain Intensity Assessed by Visual Analog Scale
Lasso di tempo: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Pain intensity at rest will be assessed using the visual analog scale. Participants will be asked to indicate their current low back and radicular leg pain intensity on a 10-cm horizontal line, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Disability Assessed by the Oswestry Disability Index
Lasso di tempo: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Disability related to low back pain will be assessed using the Oswestry Disability Index. The questionnaire includes 10 sections evaluating pain intensity and the effect of pain on daily activities. The total score is converted to a percentage from 0 to 100, with higher scores indicating greater disability.
Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Change in Neuropathic Pain Assessed by the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale
Lasso di tempo: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Neuropathic pain features will be assessed using the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale. The scale consists of symptom-based and examination-based items. A total score of 12 or higher suggests neuropathic pain, while a score below 12 suggests nociceptive pain.
Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Change in Health-Related Quality of Life Assessed by the Short Form-36 Health Survey
Lasso di tempo: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Health-related quality of life will be assessed using the Short Form-36 Health Survey. The questionnaire includes eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality, mental health, social functioning, bodily pain, and general health perception. Each domain is scored from 0 to 100, with higher scores indicating better health status.
Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Change in Functional Walking Capacity Assessed by the Six-Minute Walk Test
Lasso di tempo: Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment
Functional walking capacity will be assessed using the Six-Minute Walk Test. Participants will be instructed to walk as far as possible along a flat walking area for 6 minutes. The total distance walked in meters will be recorded, with longer distances indicating better functional walking capacity.
Baseline, 2 weeks, 6 weeks, and 12 weeks after treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Ankara City Hospital Bilkent

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2025

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 ottobre 2026

Date di iscrizione allo studio

Primo inviato

30 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 giugno 2026

Primo Inserito (Effettivo)

7 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TABED 1-25-1769

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared due to privacy and ethical restrictions.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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