Timing of physical therapy after epidural steroid injection for low back pain

ISRCTN	ISRCTN77947911
DOI	https://doi.org/10.1186/ISRCTN77947911
Sponsor	Kayseri Eğitim ve Araştırma Hastanesi
Funder	Abdulkerim GÖkoğlu Healthcare Ltd. Co.

Submission date: 10/12/2025
Registration date: 12/12/2025
Last edited: 12/12/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Low back pain and leg pain (sciatica) are very common health problems. Treatments often include medicines, physical therapy, and spinal injections (epidural steroid injections) to reduce inflammation and pain. However, it is not currently known what the best time is to start physical therapy after receiving a spinal injection. This study aims to find the optimal timing for physical therapy after a steroid injection. The goal is to determine if delaying physical therapy for 30 days allows the injection to work better and provides longer-lasting relief compared to starting it earlier or using medication alone.

Who can participate?
Adult patients (aged 18 years and over) with pain duration of at least 30 days, insufficient response to conventional medical treatments (NSAIDs, muscle relaxants) and/or prior physical therapy, and diagnoses of lumbar disc herniation (LDH), lumbar radiculopathy (LR), or axial discogenic low back pain confirmed by lumbar MRI.

What does the study involve?
The study involves three groups of patients:
A group receiving only standard medical treatment (painkillers and muscle relaxants).
A group receiving a spinal steroid injection and starting physical therapy 15 days later.
A group receiving a spinal steroid injection and starting physical therapy 30 days later.

The researchers assess the patients' pain levels and ability to perform daily activities over a 3-month period.

What are the possible benefits and risks of participating?
• Possible benefits: Participants may experience significant relief from low back and radicular leg pain, along with improved functional capacity in daily activities. The study also helps determine the optimal timing for starting physical therapy to ensure the longest-lasting pain relief.
• Possible risks: The injection procedure (TETSI) is minimally invasive. Potential minor side effects include temporary dizziness (vasovagal reaction), facial flushing, or temporary leg weakness (transient monoplegia), which typically resolve quickly without permanent issues. Serious complications are very rare.

Where is the study run from?
Kayseri State Hospital, Turkey.

When is the study starting and how long is it expected to run for?
October 2021 to March 2025

Who is funding the study?
Abdulkerim GÖkoğlu Healthcare Ltd. Co., Turkey.

Who is the main contact?
Dr Abdulkerim Gökoğlu, akerimg@hotmail.com.

Contact information

Dr Abdulkerim Gökoğlu
Principal investigator

İstiklal, Adana Çevre Yolu Cd. No:135/1
Konya
42020
Türkiye

ORCID ID	0000-0001-8071-4078
Phone	+905326445608
Email	akerimg@hotmail.com

Dr Hüseyin Yi̇ği̇t
Public, Scientific

Kavaklionu mah. Ali Baran Numanoglu cad. Urgup
Nevsehir
50400
Türkiye

ORCID ID	0000-0002-7739-9844
Phone	+905313741235
Email	huseyin.yigit@kapadokya.edu.tr

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Assessment of clinical efficacy of therapeutic epidural transforaminal steroid injection and timing of physical therapy applications
Study acronym	TETSI-PTRA-Timing
Study objectives	The primary objective of this study is to evaluate the clinical efficacy of Therapeutic Epidural Transforaminal Steroid Injection (TETSI) in the management of low back pain and radicular pain. Specifically, the study aims to investigate the optimal timing for initiating Physical Therapy and Rehabilitation (PTRA) following the injection. It compares the therapeutic outcomes (pain reduction and functional improvement) between patients initiating PTRA on day 15 versus day 30 post-injection, against a control group receiving medical treatment alone.
Ethics approval(s)	Approved 16/09/2021, Kayseri State Hospital Clinical Studies Ethics Committee (Kayseri State Hospital, Kayseri, 38010, Türkiye; +90352 336 88 84; gokogluak@erciyes.edu.tr), ref: 11535-703.01
Health condition(s) or problem(s) studied	Low back pain, Lumbar radiculopathy, Lumbar disc herniation
Intervention	The method of randomization used in this study is a computer-generated randomization list to ensure allocation concealment. Group 1 (Medical Treatment): Received oral pharmacological agents (NSAIDs, analgesics, muscle relaxants) based on clinical condition. Group 2 (Early PTRA): Underwent Therapeutic Epidural Transforaminal Steroid Injection (TETSI) followed by Physical Therapy and Rehabilitation (PTRA) starting on day 15 post-injection. Group 3 (Delayed PTRA): Underwent TETSI followed by PTRA starting on day 30 post-injection. Intervention Details: TETSI used 40 mg/ml Methylprednisolone and 0.25% Levobupivacaine. PTRA consisted of a 2-week daily program including Hot Pack (20 min), Ultrasound (10 min), and TENS (20 min)
Intervention type	Mixed
Primary outcome measure(s)	Pain intensity assessed measured using the Visual Analogue Scale (VAS), Numerical Rating Scale (NRS), Verbal Pain Intensity Scale (VPIS) and Faces Pain Scale (FPS) scores recorded by a blinded physician at baseline, day 15, and months 1 and 3
Key secondary outcome measure(s)
Completion date	30/03/2023

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	90 Years
Sex	All
Target sample size at registration	180
Total final enrolment	210
Key inclusion criteria	1. Pain duration of at least 30 days. 2. Insufficient response to conventional medical treatments (NSAIDs, muscle relaxants) and/or prior physical therapy. 3. Diagnoses of Lumbar Disc Herniation (LDH), Lumbar Radiculopathy (LR), or axial discogenic low back pain confirmed by lumbar MRI. 4. Patients without surgical indications or failed previous surgical interventions.
Key exclusion criteria	1. Diabetic and neuropathic pain. 2. Vascular atherosclerotic disease. 3. Rheumatism or inflammatory bowel disease. 4. Central nervous system disorders with a history of infarction. 5. Vitamin/mineral deficiencies, lymphedema, or history of thyroid/parathyroid iatrogenic hypocalcemia. 6. Missed appointments or irregular participation in the program.
Date of first enrolment	01/10/2021
Date of final enrolment	30/12/2022

Locations

Countries of recruitment

Türkiye

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

10/12/2025: Study’s existence confirmed by the Kayseri State Hospital Clinical Studies Ethics Committee, Turkey.