Exercise Therapy After Caudal Epidural Steroid Injection
Comparative Efficacy of Physiotherapeutic Exercise Regimens Implemented After Caudal Epidural Steroid Injection
Çankırı Karatekin University
42 participants
Apr 28, 2025
INTERVENTIONAL
Summary
\*\*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.
Eligibility
Inclusion Criteria8
- Age 18 to 70 years.
- MRI-confirmed lumbar intervertebral disc herniation.
- Has received a caudal epidural steroid injection (CESI) within the past 2 weeks at Çankırı 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 (no cardiac or orthopaedic contraindications).
- Able to attend supervised physiotherapy three times per week for six weeks.
- Willing and able to give written informed consent and to comply with study procedures.
- Sufficient Turkish literacy (minimum primary-school education) to complete questionnaires.
Exclusion Criteria8
- Uncontrolled systemic disease (e.g., poorly controlled diabetes mellitus, congestive heart failure, active hepatitis C or other significant liver disease).
- Neurological red flags such as 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 condition that precludes safe exercise participation.
- Use of systemic corticosteroids or opioid analgesics that cannot be stabilised for the duration of the trial.
- Ongoing litigation or workers' compensation claim related to low-back pain.
- Inability to communicate effectively with study staff or to follow instructions.
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Interventions
Standard physical-agent package delivered three times weekly for 6 weeks: 20 min moist hot-pack (≈70 °C hydrocollator packs); 5 min continuous therapeutic ultrasound (1 MHz, 1 W cm-²); 20 min biphasic TENS (100 Hz, 100 µs). Initiated 2 weeks after the caudal epidural steroid injection (CESI).
Supervised treadmill walking three times weekly for 6 weeks: 5 min warm-up at \~40 % HR\<sub\>max\</sub\>; 10-25 min load at 55-80 % HR\<sub\>max\</sub\> (5 % weekly progression); 5 min cool-down. Heart-rate telemetry and Borg CR-10 used to titrate intensity. Starts 2 weeks post-CESI.
Phased lumbopelvic motor-control regimen three times weekly for 6 weeks: Phase I isolated transversus abdominis/multifidus activation with pressure biofeedback; Phase II functional co-contraction with limb movements in quadruped, sitting, standing; Phase III dynamic tasks on Swiss-ball/BOSU with resistance. Progression requires pain ≤ 3/10 VAS and flawless technique. Begins 2 weeks post-CESI.
Locations(3)
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NCT06956664