Exercise Therapy After Caudal Epidural Steroid Injection

NCT06956664 | Recruiting DMC

• 1 other identifier: ec5190f6baf84e82
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

Brief 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. 1.Conventional physiotherapy alone (heat + ultrasound + TENS).
2. 2.Conventional physiotherapy plus aerobic exercise (treadmill walking at 55-80 % of age-predicted maximal heart rate with structured warm-up/cool-down).
3. 3.Conventional physiotherapy plus core-stabilisation exercise (phased activation of deep trunk musculature progressing to dynamic tasks on unstable surfaces).

Conditions

Intervertebral Disc Displacement; Low Back Pain; Radiculopathy

Keywords

Caudal Epidural Injection; Low Back Pain; Exercise Therapy; Aerobic Exercise; Core Stabilization

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity (Numeric Rating Scale, 0-10)

  Unit of Measure: points on a 0-to-10 scale Description: 11-point Numeric Rating Scale; 0 = no pain, 10 = worst imaginable pain. Change from baseline will be calculated at each follow-up. Higher scores indicate worse pain.

  Baseline; 6 weeks; 3 months; 6 months

Secondary Outcomes (5)

• Change in Disability (Oswestry Disability Index, 0-100)

  Baseline, 6 weeks, 3 months, 6 months

• Change in Health-Related Quality of Life (SF-12 Physical Component, 0-100)

  Baseline, 6 weeks, 3 months, 6 months

• Change in Health-Related Quality of Life (SF-12 Mental Component, 0-100)

  Baseline; 6 weeks; 3 months; 6 months

• Change in Lumbar Body Awareness (Fremantle Back Awareness Questionnaire, 0-36)

  Baseline; 6 weeks; 3 months; 6 months

• Return-to-Work Days

  Up to 6 months

Other Outcomes (1)

• Adverse Events Related to Exercise or CESI

  Throughout 6-week intervention and 6-month follow-up

Study Arms (3)

Conventional Physiotherapy

ACTIVE COMPARATOR

Other: Conventional Physiotherapy (moist heat, therapeutic ultrasound, TENS)

Other: Conventional Physiotherapy

Aerobic Exercise + Conventional Physiotherapy

EXPERIMENTAL

* Behavioral: Aerobic Exercise (treadmill walking) * Other: Conventional Physiotherapy

Other: Conventional Physiotherapy; Behavioral: Aerobic Exercise Programme

Core-Stabilization Exercise + Conventional Physiotherapy

EXPERIMENTAL

* Behavioral: Core-Stabilisation Exercise * Other: Conventional Physiotherapy

Other: Conventional Physiotherapy; Behavioral: Core-Stabilization Exercise Programme

Interventions

Conventional Physiotherapy OTHER

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).

Aerobic Exercise + Conventional Physiotherapy; Conventional Physiotherapy; Core-Stabilization Exercise + Conventional Physiotherapy

Aerobic Exercise Programme BEHAVIORAL

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.

Aerobic Exercise + Conventional Physiotherapy

Core-Stabilization Exercise Programme BEHAVIORAL

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.

Core-Stabilization Exercise + Conventional Physiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (3)

Çankırı Karatekin University

Çankırı, Turkey (Türkiye)

ACTIVE NOT RECRUITING

Çankırı State Hospital

Çankırı, Turkey (Türkiye)

RECRUITING

Çankırı State Hospital

Çankırı, Turkey (Türkiye)

RECRUITING

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MeSH Terms

Conditions

Intervertebral Disc Displacement; Low Back Pain; Radiculopathy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Ceyhun Türkmen, PhD

CONTACT

+90 376 218 95 00; ceyhunturkmen@karatekin.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The treating physiotherapists and participants cannot be blinded because the nature of the exercise programmes is overt. However, (i) outcome assessors who perform all baseline and follow-up measurements and (ii) the trial statistician responsible for primary analyses will remain unaware of group allocation. Randomisation codes are stored in sealed, opaque envelopes by a study coordinator not involved in assessment or analysis, and participants are reminded not to disclose their exercise group during evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: Randomised, three-arm, parallel-group trial. Participants are allocated 1:1:1 to one of the following interventions delivered for six weeks: Conventional physiotherapy alone (heat, ultrasound, TENS) Conventional physiotherapy + aerobic treadmill exercise Conventional physiotherapy + progressive core-stabilisation exercise Groups receive their assigned programme concurrently for the full study duration; no crossover or adaptive sequencing is planned.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: May 4, 2025
• Study Start: April 28, 2025
• Primary Completion: January 15, 2026
• Study Completion: February 15, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

TU (3)