"Effectiveness of Physical Therapy Added to Transforaminal Injection in Lumbar Radicular Pain"

The Efficacy of Conventional Physical Therapy Added to Transforaminal Injection in Lumbar Radicular Pain

The purpose of this study is to investigate whether adding conventional physical therapy modalities to transforaminal epidural steroid injection (TFESE) provides additional benefits in patients with acute radicular pain due to lumbar disc herniation. While TFESE is a known effective treatment for radicular pain, this research aims to evaluate if physical therapy can further improve pain duration, functional level, disability, and depression scores.

Participants will be divided into two groups based on their ability to attend a physical therapy program:

Group 1: Patients receiving only ultrasound-guided TFESE and a standard home exercise program.

Group 2: Patients receiving ultrasound-guided TFESE combined with 10 sessions of physical therapy (including hot-pack, therapeutic ultrasound, and TENS) and a standard home exercise program.

The study will compare the effects of these treatments on pain intensity, disability, spinal range of motion, and depression levels. Assessments will be conducted at baseline (before injection), 1 hour after injection, and at the 1st and 3rd-month follow-up visits.

Study Overview

• Status: Completed
• Conditions: Low Back Pain (LBP); Lumbar Disc Herniation With Radiculopathy
• Intervention / Treatment: Drug: TFESE; Other: TFESE+ CONVENTIONAL PHYSIOTHERAPY

Detailed Description

This study is designed as a single-center, prospective, observational study. Participants are patients diagnosed with lumbar disc herniation (LDH) via physical examination and magnetic resonance imaging (MRI) who present with acute radicular pain symptoms.

Intervention Groups:

Patients are divided into two groups based on their ability to participate in a physical therapy program.

Group 1 (TFESE + PT): Participants receive only ultrasound-guided TFESE.

Group 2 (TFESE Only): Participants receive ultrasound-guided transforaminal epidural steroid injection (TFESE) followed by 10 sessions of conventional physical therapy.

Both groups are provided with a standard home exercise program focusing on lumbar range of motion, core stabilization, and strengthening of abdominal and back muscles.

Injection Procedure:

The TFESE is performed under ultrasound guidance using a convex probe (3 MHz). With the patient in the prone position, the needle (22-gauge, 3.5 inch, Quincke-tip) is inserted using an in-plane approach toward the lateral aspect of the lamina. After confirming the position in both axial and parasagittal planes and performing negative aspiration, a mixture is injected. The injectate consists of 2 ml 20 mg/ml Lidocaine Hydrochloride, 1 ml Betamethasone Dipropionate/Sodium Phosphate (5 mg + 2 mg/ml), and 3 ml 0.9% Sodium Chloride.

Physical Therapy Protocol:

The physical therapy program for Group 1 consists of 10 sessions, including hot-pack application, therapeutic ultrasound, and Transcutaneous Electrical Nerve Stimulation (TENS).

Follow-up and Assessment:

Clinical evaluations and patient-reported outcomes are recorded at baseline, 1 hour post-injection, and at 1-month and 3-month follow-ups. These assessments include pain intensity (NRS), functional disability (Oswestry Disability Index), depression levels (Beck Depression Inventory), and neuropathic pain presence (DN4).

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06230
      • Ankara Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

The study population consists of patients aged 18-65 who presented to the Physical Medicine and Rehabilitation (PMR) outpatient clinic with complaints of acute radicular pain and were diagnosed with lumbar disc herniation (LDH) via clinical examination and Magnetic Resonance Imaging (MRI). The population includes individuals who have failed to respond to initial conservative medical treatments and are candidates for transforaminal epidural steroid injection (TFESE). Participants are recruited from patients who meet the clinical criteria and are willing to undergo either the injection alone or a combination of injection and a structured physical therapy program.

Description

Inclusion Criteria:

• Patients aged between 18 and 65 years.
• Diagnosis of lumbar disc herniation confirmed by physical examination and Magnetic Resonance Imaging (MRI) within the last 6 months.
• Presence of acute radicular pain symptoms lasting more than 3 months.
• Failure to respond to conservative medical treatments (e.g., medication, rest).
• Voluntary participation and signed written informed consent.

Exclusion Criteria:

• History of previous lumbar spinal surgery.
• Presence of progressive motor deficits or Cauda Equina Syndrome.
• Pregnancy or breastfeeding.
• Diagnosis of malignancy, inflammatory rheumatic diseases, or neurodegenerative disorders.
• Severe obesity (Body Mass Index > 40 kg/m²).
• Known allergy to injection materials (Lidocaine, Betamethasone).
• Active local or systemic infection.
• Presence of bleeding disorders or use of anticoagulants that cannot be safely discontinued.
• Having received an epidural steroid injection or a clinical physical therapy program within the last 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ARM 1 TFESE; Participants in this group receive only a single-level ultrasound-guided transforaminal epidural steroid injection (TFESE) at the symptomatic level. No clinical physical therapy modalities are applied. All participants in this group are provided with the same standardized home exercise program as Group 2 to maintain a baseline level of activity.	Drug: TFESE; ultrasound-guided transforaminal epidural steroid injection (TFESE) Participants in this group receive only a single-level ultrasound-guided transforaminal epidural steroid injection (TFESE) at the symptomatic level. No clinical physical therapy modalities are applied. All participants in this group are provided with the same standardized home exercise program as Group 2 to maintain a baseline level of activity.
Active Comparator: ARM 2 TFESE+ CONVENTIONAL PHYSIOTHERAPY; Device: ultrasound-guided transforaminal epidural steroid injection (TFESE)+ conventional physiotherapy Description: Participants in this group receive a single-level ultrasound-guided transforaminal epidural steroid injection (TFESE) at the symptomatic level. Following the injection, they undergo a 10-session conventional physical therapy program (5 days a week for 2 weeks) consisting of hot-pack application (20 min), therapeutic ultrasound (1.5 watt/cm² for 6 min), and TENS (20 min). Additionally, a standardized home exercise program is provided.	Other: TFESE+ CONVENTIONAL PHYSIOTHERAPY; Device: ultrasound-guided transforaminal epidural steroid injection (TFESE)+ conventional physiotherapy Description: Participants in this group receive a single-level ultrasound-guided transforaminal epidural steroid injection (TFESE) at the symptomatic level. Following the injection, they undergo a 10-session conventional physical therapy program (5 days a week for 2 weeks) consisting of hot-pack application (20 min), therapeutic ultrasound (1.5 watt/cm² for 6 min), and TENS (20 min). Additionally, a standardized home exercise program is provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity measured by the Numeric Rating Scale (NRS)	The Numeric Rating Scale (NRS) is an 11-point scale used to assess pain intensity, where 0 represents "no pain" and 10 represents "the worst possible pain." Higher scores indicate greater pain severity.	Baseline, 1 hour post-injection, 1 month, and 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Disability measured by the Oswestry Disability Index (ODI)	The ODI is a questionnaire used to measure a patient's functional disability for low back pain. It contains 10 topics. Each item is scored 0-5. The total score ranges from 0 to 100, where higher scores indicate more severe disability.	Baseline, 1 month, and 3 months.
Change in Depression Levels measured by the Beck Depression Inventory (BDI)	The BDI is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. Each item is scored 0-3. Total scores range from 0 to 63; higher scores indicate higher levels of depression.	Baseline and 3 months.
Change in Neuropathic Pain Presence measured by the DN4 (Douleur Neuropathique 4) Questionnaire	The DN4 is a screening tool for neuropathic pain consisting of 10 items. A score of 4/10 or higher suggests neuropathic pain. It helps distinguish nociceptive pain from neuropathic pain.	Baseline, 1 month, and 3 months.
Change in Spinal Range of Motion (ROM)	Clinical measurement of the lumbar spine flexibility (e.g., using the Schober test or similar clinical assessment) to evaluate functional improvement.	Baseline, 1 hour post-injection, 1 month, and 3 months.

Collaborators and Investigators

• Sponsor: Ankara Training and Research Hospital
• Investigators: Principal Investigator: TÜLAY TİFTİK TEKDEMİR, Prof. Dr., Ankara Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: TENS; Physical Therapy; Lumbar Radiculopathy; Therapeutic Ultrasound; Lumbar Disc Herniation; Transforaminal Epidural Steroid Injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Hernia; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Radiculopathy; Intervertebral Disc Displacement; Low Back Pain
• Other Study ID Numbers: E-93471371-514.10-273889796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to ensure the privacy and confidentiality of the participants, in accordance with the informed consent provided and the institutional ethics committee guidelines. Only aggregated study results will be made available through publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No