Lumbar Disc Herniation With RadiculopathyNCT07467421
"Effectiveness of Physical Therapy Added to Transforaminal Injection in Lumbar Radicular Pain"
A study testing TFESE and TFESE+ CONVENTIONAL PHYSIOTHERAPY in people with Lumbar Disc Herniation With Radiculopathy and Low Back Pain (LBP), run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation With Radiculopathy, Low Back Pain (LBP)
- What is being tested?
- TFESE and TFESE+ CONVENTIONAL PHYSIOTHERAPY
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Ankara, 06230
About this study
Official title: 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:
Read more
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.
Read the 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).
- Being tested
- TFESE, TFESE+ CONVENTIONAL PHYSIOTHERAPY
- Keywords
- Transforaminal Epidural Steroid Injection, Physical Therapy, Lumbar Radiculopathy, Therapeutic Ultrasound, TENS, Lumbar Disc Herniation
- Medical subject headings
- Low Back Pain, Radiculopathy, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: TFESE+ CONVENTIONAL PHYSIOTHERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 hour post-injection, 1 month, and 3 months.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1 hour post-injection, 1 month, and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Jun 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc Herniation With RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursel Doğanyiğit Kuzan, Ankara Training and Research Hospital
- Investigators
- TÜLAY TİFTİK TEKDEMİR, Prof. Dr., Principal investigator, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467421
- Sponsor's protocol ID
- E-93471371-514.10-273889796
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Conventional Physical Therapy Added to Transforaminal Injection in Lumbar Radicular Pain
- ClinicalTrials.gov ID
- NCT07467421
- Acronym / sponsor ID
- E-93471371-514.10-273889796
- Keywords
- Transforaminal Epidural Steroid Injection, Physical Therapy, Lumbar Radiculopathy, Therapeutic Ultrasound, TENS, Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 TFESE | Active comparator | Drug: TFESEParticipants 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 2 TFESE+ CONVENTIONAL PHYSIOTHERAPY | Active comparator | Other: TFESE+ CONVENTIONAL PHYSIOTHERAPYDevice: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TFESEultrasound-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. | Drug | ARM 1 TFESE |
| TFESE+ CONVENTIONAL PHYSIOTHERAPYDevice: 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 | ARM 2 TFESE+ CONVENTIONAL PHYSIOTHERAPY |
Primary outcome
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.
4 secondary outcomes
Change in Functional Disability measured by the Oswestry Disability Index (ODI)
Time frame: Baseline, 1 month, and 3 months.
Change in Depression Levels measured by the Beck Depression Inventory (BDI)
Time frame: 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.
Change in Spinal Range of Motion (ROM)
Time frame: Baseline, 1 hour post-injection, 1 month, and 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TÜLAY TİFTİK TEKDEMİR, Prof. Dr. principal investigator
Ankara Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TFESE and TFESE+ CONVENTIONAL PHYSIOTHERAPY in people with Lumbar Disc Herniation With Radiculopathy and Low Back Pain (LBP), run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity measured by the Numeric Rating Scale (NRS) (time frame: Baseline, 1 hour post-injection, 1 month, and 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.