Actively Recruiting
Exercise Therapy After Caudal Epidural Steroid Injection
Led by Çankırı Karatekin University · Updated on 2025-08-08
42
Participants Needed
3
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
\*\*Brief Summary\*\* Lumbar radicular pain arising from intervertebral disc herniation is commonly managed with a caudal epidural steroid injection (CESI), a minimally invasive procedure that delivers anti-inflammatory medication to the sacral hiatus. Although CESI affords short-term analgesia, a sizable proportion of patients continue to experience pain-related disability and diminished quality of life, underscoring the need for optimised post-injection rehabilitation. This single-centre, three-arm, parallel-group randomised controlled trial will evaluate the comparative efficacy of two evidence-informed exercise paradigms-moderate-intensity aerobic training and progressive lumbopelvic stabilisation-when each is superimposed upon a standard physiotherapy package of heat, therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS). Forty-two adults (18-70 years) with MRI-confirmed lumbar disc herniation who have undergone CESI at Çankırı State Hospital will be randomly allocated (1:1:1) to one of the following six-week interventions, initiated two weeks post-injection and delivered thrice weekly under physiotherapist supervision: 1. Conventional physiotherapy alone (heat + ultrasound + TENS). 2. Conventional physiotherapy plus aerobic exercise (treadmill walking at 55-80 % of age-predicted maximal heart rate with structured warm-up/cool-down). 3. Conventional physiotherapy plus core-stabilisation exercise (phased activation of deep trunk musculature progressing to dynamic tasks on unstable surfaces). Primary end-points are pain intensity (10 cm Visual Analogue Scale) and back-specific disability (Oswestry Disability Index). Secondary end-points include generic health-related quality of life (SF-12) and lumbar proprioceptive body awareness (Fremantle Back Awareness Questionnaire). Outcomes will be captured at baseline, post-intervention (6 weeks) and at 3- and 6-month follow-up to ascertain both immediate and sustained effects. Study Question Does adjunctive aerobic or core-stabilisation exercise confer superior reductions in pain and disability, and greater gains in quality of life and body awareness, compared with conventional physiotherapy alone in adults following CESI for lumbar disc herniation? It is hypothesised that both exercise approaches will yield clinically and statistically superior outcomes relative to standard care, with stabilisation training providing the most durable functional benefits. Findings are expected to refine post-CESI rehabilitation algorithms and inform evidence-based clinical guidance for physiotherapists managing lumbar disc pathology.
CONDITIONS
Official Title
Exercise Therapy After Caudal Epidural Steroid Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- MRI-confirmed lumbar intervertebral disc herniation
- Received a caudal epidural steroid injection within the past 2 weeks at ank1 State Hospital
- Low-back or leg pain intensity 3 cm on a 10-cm Visual Analogue Scale after the injection
- Medically cleared for moderate aerobic and core-stabilisation exercise
- Able to attend supervised physiotherapy three times per week for six weeks
- Willing and able to give written informed consent and comply with study procedures
- Sufficient Turkish literacy to complete questionnaires
You will not qualify if you...
- Uncontrolled systemic disease such as poorly controlled diabetes, congestive heart failure, or significant liver disease
- Neurological red flags like myelopathy or cauda equina syndrome
- Previous lumbar spine surgery at the affected disc level
- Current pregnancy or planning pregnancy during the study period
- Severe musculoskeletal, cardiovascular, or respiratory conditions preventing safe exercise
- Use of systemic corticosteroids or opioid analgesics that cannot be stabilized during the trial
- Ongoing litigation or workers' compensation claim related to low-back pain
- Inability to communicate effectively with study staff or follow instructions
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Çankırı Karatekin University
Çankırı, Turkey (Türkiye)
Active, Not Recruiting
2
Çankırı State Hospital
Çankırı, Turkey (Türkiye)
Actively Recruiting
3
Çankırı State Hospital
Çankırı, Turkey (Türkiye)
Actively Recruiting
Research Team
C
Ceyhun Türkmen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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