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

Ankara Training and Research Hospital76 enrolled

Overview

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.

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).

Interventions

TFESEDRUG

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.

TFESE+ CONVENTIONAL PHYSIOTHERAPYOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 1 hour post-injection, 1 month, and 3 months.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.