"Effectiveness of Physical Therapy Added to Transforaminal Injection in Lumbar Radicular Pain" (NCT07467421) | Clinical Trial Compass
CompletedNot Applicable
"Effectiveness of Physical Therapy Added to Transforaminal Injection in Lumbar Radicular Pain"
Turkey (Türkiye)76 participantsStarted 2025-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity measured by the Numeric Rating Scale (NRS)
Timeframe: Baseline, 1 hour post-injection, 1 month, and 3 months.