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

March 26, 2026 updated by: Nursel Doğanyiğit Kuzan, Ankara Training and Research Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity measured by the Numeric Rating Scale (NRS)
Time Frame: Baseline, 1 hour post-injection, 1 month, and 3 months.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Functional Disability measured by the Oswestry Disability Index (ODI)
Time Frame: Baseline, 1 month, and 3 months.
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)
Time Frame: Baseline and 3 months.
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
Time Frame: Baseline, 1 month, and 3 months.
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)
Time Frame: Baseline, 1 hour post-injection, 1 month, and 3 months.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: TÜLAY TİFTİK TEKDEMİR, Prof. Dr., Ankara Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Back Pain (LBP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings