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

NCT07467421 | Completed

• 1 other identifier: E-93471371-514.10-273889796
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Transforaminal Epidural Steroid Injection; Physical Therapy; Lumbar Radiculopathy; Therapeutic Ultrasound; TENS; Lumbar Disc Herniation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Functional Disability measured by the Oswestry Disability Index (ODI)

  Baseline, 1 month, and 3 months.

• Change in Depression Levels measured by the Beck Depression Inventory (BDI)

  Baseline and 3 months.

• Change in Neuropathic Pain Presence measured by the DN4 (Douleur Neuropathique 4) Questionnaire

  Baseline, 1 month, and 3 months.

• Change in Spinal Range of Motion (ROM)

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

Study Arms (2)

ARM 1 TFESE

ACTIVE COMPARATOR

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

ARM 2 TFESE+ CONVENTIONAL PHYSIOTHERAPY

ACTIVE COMPARATOR

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

Interventions

TFESE DRUG

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.

ARM 1 TFESE

TFESE+ CONVENTIONAL PHYSIOTHERAPY OTHER

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.

ARM 2 TFESE+ CONVENTIONAL PHYSIOTHERAPY

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain; Radiculopathy; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical

Study Officials

• TÜLAY TİFTİK TEKDEMİR, Prof. Dr.

  Ankara Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)