NCT07467421

"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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Ankara Training and Research Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

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).

Conditions

• Lumbar Disc Herniation With Radiculopathy
• Low Back Pain (LBP)

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2026-03-12
• Last updated: 2026-03-31

Locations

1 site across 1 country: Turkey (Türkiye)