Intervertebral Disc DisplacementCAPERNCT06956664
Exercise Therapy After Caudal Epidural Steroid Injection
A study testing Conventional Physiotherapy, Aerobic Exercise Programme and Core-Stabilization Exercise Programme in people with Intervertebral Disc Displacement and Low Back Pain, run by Çankırı Karatekin University at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intervertebral Disc Displacement, Low Back Pain, Radiculopathy
- What is being tested?
- Conventional Physiotherapy, Aerobic Exercise Programme and Core-Stabilization Exercise Programme
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 28 Apr 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites, 2 recruiting
- Active, not recruiting
Çankırı Karatekin University
Çankırı
- Recruiting
Çankırı State Hospital
Çankırı
Serpil Arslan, MSc, +905311017392
- Recruiting
Çankırı State Hospital
Çankırı
Serpil Arslan, +905311017392, serpilarslan03@gmail.com
Ceyhun Türkmen
About this study
Official title: Comparative Efficacy of Physiotherapeutic Exercise Regimens Implemented After Caudal Epidural Steroid Injection
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.
Read more
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:
- Conventional physiotherapy alone (heat + ultrasound + TENS).
- Conventional physiotherapy plus aerobic exercise (treadmill walking at 55-80 % of age-predicted maximal heart rate with structured warm-up/cool-down).
- 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.
Read the detailed description
Scientific Rationale and Background Caudal epidural steroid injection (CESI) is widely employed to attenuate lumbosacral radicular pain by delivering glucocorticoids into the sacral hiatus, thereby diminishing local biochemical inflammation around the affected nerve roots. While CESI frequently yields rapid analgesia, pain recurrence and activity limitation are common within three to six months, indicating that pharmacological attenuation of inflammation alone is insufficient to restore neuromuscular control and functional capacity. Emerging evidence suggests that structured exercise commenced shortly after CESI can exploit the "analgesic window" to retrain motor patterns, enhance spinal stability, and improve cardiovascular fitness-yet the optimal exercise paradigm remains unclear. Aerobic conditioning may promote anti-inflammatory myokine release and general de-conditioning reversal, whereas lumbopelvic stabilisation targets segmental control deficits and proprioceptive impairment-both recognised contributors to chronicity in lumbar disc pathology.
Study Design and Setting This is a single-centre, prospective, three-arm, parallel-group, superiority randomised controlled trial conducted at the Department of Physiotherapy, Çankırı State Hospital, Türkiye. Allocation (1:1:1) is computer-generated with permuted blocks of variable size; assignments are sealed in sequentially numbered opaque envelopes by an independent statistician to ensure allocation concealment. Outcome assessors and data analysts are blinded to group assignment. Interventions are delivered in a dedicated physiotherapy gymnasium under the supervision of senior musculoskeletal physiotherapists trained in study procedures.
Intervention Logic
Each participant receives a two-week "wash-in" period following CESI to permit stabilisation of acute pharmacodynamic effects. Thereafter, three arms are implemented over six weeks (18 supervised sessions):
- Conventional Physiotherapy (control) - superficial moist heat (20 min, 70 °C hydrocollator packs), continuous ultrasound (1 MHz, 1.0 W cm-², 5 min), and biphasic TENS (100 Hz, 100 µs, 20 min).
- Conventional Physiotherapy + Aerobic Exercise - identical modality package followed by treadmill walking at 55-80 % age-predicted HR_max with 5 min warm-up, 10-25 min load (weekly 5 % progression), and 5 min cool-down. Heart rate is telemetrically monitored; intensity is titrated using the Borg CR-10 scale and Tanaka equation (208-0.7·age).
- Conventional Physiotherapy + Core-Stabilisation Exercise - modality package followed by a phased stabilisation protocol:
- Phase I: isolated transversus abdominis and multifidus activation in supine/prone using pressure biofeedback (2 weeks).
- Phase II: functional co-contraction with limb movements in quadruped, sitting, and standing (2 weeks).
- Phase III: dynamic tasks on unstable surfaces (Swiss-ball, BOSU) incorporating resistance bands (2 weeks).
Progression criteria include pain ≤3/10 on VAS and flawless technique for ≥10 repetitions; repetitions, load, or surface instability are advanced by ~10 % weekly.
All participants receive a standardised education booklet on spine-sparing strategies and are advised to maintain normal activities.
Sample Size Justification Using an anticipated between-group effect size of d = 1.0 for pain reduction-derived from prior work on CESI-augmented exercise (Cohen's f = 0.5)-42 participants (14 per arm) provide 80 % power (α = 0.05, two-sided) to detect clinically important differences, allowing for 25 % attrition.
Data Management and Statistical Plan Data are entered into REDCap with double-entry verification. The primary analysis follows the intention-to-treat principle, employing linear mixed-effects models with random intercepts for participants, fixed effects for group, time, and their interaction, and baseline score as covariate. Missing data will be handled using restricted maximum likelihood under a missing-at-random assumption; sensitivity analyses will include multiple imputation. Secondary outcomes will be analysed similarly with Bonferroni-adjusted confidence intervals. Effect sizes (Hedges g) and minimal clinically important differences will be reported.
Safety Monitoring Adverse events-including exacerbation of radicular pain, hemodynamic instability during aerobic sessions, or procedure-related complications-are recorded at each visit. An independent physician adjudicates seriousness and relatedness; criteria for withdrawal include VAS ≥ 7 persisting >48 h or cardiovascular red-flags according to American College of Sports Medicine guidelines. A Data Safety Monitoring Sub-committee reviews unblinded safety reports quarterly.
*Knowledge Translation* Results will inform evidence-based guidelines on post-CESI rehabilitation, disseminated via peer-reviewed publication, conference presentation, and integration into continuing professional development modules for physiotherapists. De-identified datasets and analytic code will be deposited in an open repository within 12 months of primary outcome publication, aligning with FAIR data principles and UK Research Councils' open-science policy.
In summary, this rigorously designed trial seeks to delineate whether adjunctive aerobic or motor-control-oriented exercise offers superior and durable benefits over conventional modalities alone in the critical post-injection period for patients with lumbar disc herniation, thereby refining best-practice rehabilitation pathways.
- Being tested
- Conventional Physiotherapy, Aerobic Exercise Programme, Core-Stabilization Exercise Programme
- Keywords
- Caudal Epidural Injection, Low Back Pain, Exercise Therapy, Aerobic Exercise, Core Stabilization
- Medical subject headings
- Intervertebral Disc Displacement, Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional PhysiotherapyOther
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 ProgrammeBehavioural
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.
Core-Stabilization Exercise ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Other: Conventional Physiotherapy (moist heat, therapeutic ultrasound, TENS) Receives: Other: Conventional Physiotherapy |
| Aerobic Exercise + Conventional Physiotherapy | Experimental | * Behavioral: Aerobic Exercise (treadmill walking)
* Other: Conventional Physiotherapy Receives: Other: Conventional Physiotherapy; Behavioral: Aerobic Exercise Programme |
| Core-Stabilization Exercise + Conventional Physiotherapy | Experimental | * Behavioral: Core-Stabilisation Exercise
* Other: Conventional Physiotherapy Receives: Other: Conventional Physiotherapy; Behavioral: Core-Stabilization Exercise Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 6 weeks; 3 months; 6 months
Secondary outcomes (5)
Change in Disability (Oswestry Disability Index, 0-100)
Unit of Measure: percentage points (0-100) Description: Oswestry Disability Index v2.1a; higher scores denote greater disability. Change from baseline will be reported.
Measured: Baseline, 6 weeks, 3 months, 6 months
Change in Health-Related Quality of Life (SF-12 Physical Component, 0-100)
Unit of Measure: points (0-100) Description: Short-Form-12 v2 Physical Component Summary (PCS); higher scores represent better quality of life.
Measured: Baseline, 6 weeks, 3 months, 6 months
Change in Health-Related Quality of Life (SF-12 Mental Component, 0-100)
Short-Form-12 v2. Mental Component Summary (MCS) scores; higher values = better QoL. Change from baseline calculated for each follow-up.
Measured: Baseline; 6 weeks; 3 months; 6 months
Change in Lumbar Body Awareness (Fremantle Back Awareness Questionnaire, 0-36)
Unit of Measure: points (0-36) Description: 9-item FreBAQ; higher scores reflect poorer body perception. Change from baseline reported.
Measured: Baseline; 6 weeks; 3 months; 6 months
Return-to-Work Days
Unit of Measure: days Description: Self-reported calendar days from CESI to full resumption of habitual occupational duties. Lower values indicate faster return.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start28 Apr 2025
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Intervertebral Disc DisplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceyhun Türkmen, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956664
- Sponsor's protocol ID
- ec5190f6baf84e82
- Acronym
- CAPER
- Status last verified
- Aug 2025
- First submitted
- 23 Apr 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified participant-level dataset and accompanying data dictionary will be deposited in an open-access repository (e.g., Open Science Framework) within 12 months of publication of the primary results, accessible to qualified researchers under a CC-BY license.
Publications
Fornari M, Robertson SC, Pereira P, Zileli M, Anania CD, Ferreira A, Ferrari S, Gatti R, Costa F. Conservative Treatment and Percutaneous Pain Relief Techniques in Patients with Lumbar Spinal Stenosis: WFNS Spine Committee Recommendations. World Neurosurg X. 2020 Jun 23;7:100079. doi: 10.1016/j.wnsx.2020.100079. eCollection 2020 Jul.
PubMed 32613192Zhang J, Zhang R, Wang Y, Dang X. Efficacy of epidural steroid injection in the treatment of sciatica secondary to lumbar disc herniation: a systematic review and meta-analysis. Front Neurol. 2024 May 22;15:1406504. doi: 10.3389/fneur.2024.1406504. eCollection 2024.
PubMed 38841695Yang H, Liu H, Li Z, Zhang K, Wang J, Wang H, Zheng Z. Low back pain associated with lumbar disc herniation: role of moderately degenerative disc and annulus fibrous tears. Int J Clin Exp Med. 2015 Feb 15;8(2):1634-44. eCollection 2015.
PubMed 25932092Yaman O, Guchkha A, Vaishya S, Zileli M, Zygourakis C, Oertel J. The role of conservative treatment in lumbar disc herniations: WFNS spine committee recommendations. World Neurosurg X. 2024 Feb 13;22:100277. doi: 10.1016/j.wnsx.2024.100277. eCollection 2024 Apr.
PubMed 38389961Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.
PubMed 15129077Wilby MJ, Best A, Wood E, Burnside G, Bedson E, Short H, Wheatley D, Hill-McManus D, Sharma M, Clark S, Baranidharan G, Price C, Mannion R, Hutchinson PJ, Hughes DA, Marson A, Williamson PR. Surgical microdiscectomy versus transforaminal epidural steroid injection in patients with sciatica secondary to herniated lumbar disc (NERVES): a phase 3, multicentre, open-label, randomised controlled trial and economic evaluation. Lancet Rheumatol. 2021 Mar 18;3(5):e347-e356. doi: 10.1016/S2665-9913(21)00036-9. eCollection 2021 May.
PubMed 33969319Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18.
PubMed 27327235Waddell G, Feder G, Lewis M. Systematic reviews of bed rest and advice to stay active for acute low back pain. Br J Gen Pract. 1997 Oct;47(423):647-52.
PubMed 9474831Verheijen EJA, Bonke CA, Amorij EMJ, Vleggeert-Lankamp CLA. Epidural steroid compared to placebo injection in sciatica: a systematic review and meta-analysis. Eur Spine J. 2021 Nov;30(11):3255-3264. doi: 10.1007/s00586-021-06854-9. Epub 2021 May 11.
PubMed 33974132Van Boxem K, Rijsdijk M, Hans G, de Jong J, Kallewaard JW, Vissers K, van Kleef M, Rathmell JP, Van Zundert J. Safe Use of Epidural Corticosteroid Injections: Recommendations of the WIP Benelux Work Group. Pain Pract. 2019 Jan;19(1):61-92. doi: 10.1111/papr.12709. Epub 2018 Jul 2.
PubMed 29756333Taspinar G, Angin E, Oksuz S. The effects of Pilates on pain, functionality, quality of life, flexibility and endurance in lumbar disc herniation. J Comp Eff Res. 2023 Jan;12(1):e220144. doi: 10.2217/cer-2022-0144. Epub 2022 Dec 1.
PubMed 36453667Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.
PubMed 35730511Skovrlj B, Gilligan J, Cutler HS, Qureshi SA. Minimally invasive procedures on the lumbar spine. World J Clin Cases. 2015 Jan 16;3(1):1-9. doi: 10.12998/wjcc.v3.i1.1.
PubMed 25610845Singh S, Kumar S, Chahal G, Verma R. Selective nerve root blocks vs. caudal epidural injection for single level prolapsed lumbar intervertebral disc - A prospective randomized study. J Clin Orthop Trauma. 2017 Apr-Jun;8(2):142-147. doi: 10.1016/j.jcot.2016.02.001. Epub 2016 Feb 22.
PubMed 28720990Sany SA, Mitsi M, Tanjim T, Rahman M. The effectiveness of different aerobic exercises to improve pain intensity and disability in chronic low back pain patients: a systematic review. F1000Res. 2023 Jul 18;11:136. doi: 10.12688/f1000research.75440.2. eCollection 2022.
PubMed 37854288
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Physiotherapeutic Exercise Regimens Implemented After Caudal Epidural Steroid Injection
- ClinicalTrials.gov ID
- NCT06956664
- Acronym / sponsor ID
- CAPER / ec5190f6baf84e82
- Keywords
- Caudal Epidural Injection, Low Back Pain, Exercise Therapy, Aerobic Exercise, Core Stabilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Conventional physiotherapy alone (heat + ultrasound + TENS).
- Conventional physiotherapy plus aerobic exercise (treadmill walking at 55-80 % of age-predicted maximal heart rate with structured warm-up/cool-down).
- 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.
Detailed description
Scientific Rationale and Background Caudal epidural steroid injection (CESI) is widely employed to attenuate lumbosacral radicular pain by delivering glucocorticoids into the sacral hiatus, thereby diminishing local biochemical inflammation around the affected nerve roots. While CESI frequently yields rapid analgesia, pain recurrence and activity limitation are common within three to six months, indicating that pharmacological attenuation of inflammation alone is insufficient to restore neuromuscular control and functional capacity. Emerging evidence suggests that structured exercise commenced shortly after CESI can exploit the "analgesic window" to retrain motor patterns, enhance spinal stability, and improve cardiovascular fitness-yet the optimal exercise paradigm remains unclear. Aerobic conditioning may promote anti-inflammatory myokine release and general de-conditioning reversal, whereas lumbopelvic stabilisation targets segmental control deficits and proprioceptive impairment-both recognised contributors to chronicity in lumbar disc pathology.
Study Design and Setting This is a single-centre, prospective, three-arm, parallel-group, superiority randomised controlled trial conducted at the Department of Physiotherapy, Çankırı State Hospital, Türkiye. Allocation (1:1:1) is computer-generated with permuted blocks of variable size; assignments are sealed in sequentially numbered opaque envelopes by an independent statistician to ensure allocation concealment. Outcome assessors and data analysts are blinded to group assignment. Interventions are delivered in a dedicated physiotherapy gymnasium under the supervision of senior musculoskeletal physiotherapists trained in study procedures.
Intervention Logic
Each participant receives a two-week "wash-in" period following CESI to permit stabilisation of acute pharmacodynamic effects. Thereafter, three arms are implemented over six weeks (18 supervised sessions):
- Conventional Physiotherapy (control) - superficial moist heat (20 min, 70 °C hydrocollator packs), continuous ultrasound (1 MHz, 1.0 W cm-², 5 min), and biphasic TENS (100 Hz, 100 µs, 20 min).
- Conventional Physiotherapy + Aerobic Exercise - identical modality package followed by treadmill walking at 55-80 % age-predicted HR_max with 5 min warm-up, 10-25 min load (weekly 5 % progression), and 5 min cool-down. Heart rate is telemetrically monitored; intensity is titrated using the Borg CR-10 scale and Tanaka equation (208-0.7·age).
- Conventional Physiotherapy + Core-Stabilisation Exercise - modality package followed by a phased stabilisation protocol:
- Phase I: isolated transversus abdominis and multifidus activation in supine/prone using pressure biofeedback (2 weeks).
- Phase II: functional co-contraction with limb movements in quadruped, sitting, and standing (2 weeks).
- Phase III: dynamic tasks on unstable surfaces (Swiss-ball, BOSU) incorporating resistance bands (2 weeks).
Progression criteria include pain ≤3/10 on VAS and flawless technique for ≥10 repetitions; repetitions, load, or surface instability are advanced by ~10 % weekly.
All participants receive a standardised education booklet on spine-sparing strategies and are advised to maintain normal activities.
Sample Size Justification Using an anticipated between-group effect size of d = 1.0 for pain reduction-derived from prior work on CESI-augmented exercise (Cohen's f = 0.5)-42 participants (14 per arm) provide 80 % power (α = 0.05, two-sided) to detect clinically important differences, allowing for 25 % attrition.
Data Management and Statistical Plan Data are entered into REDCap with double-entry verification. The primary analysis follows the intention-to-treat principle, employing linear mixed-effects models with random intercepts for participants, fixed effects for group, time, and their interaction, and baseline score as covariate. Missing data will be handled using restricted maximum likelihood under a missing-at-random assumption; sensitivity analyses will include multiple imputation. Secondary outcomes will be analysed similarly with Bonferroni-adjusted confidence intervals. Effect sizes (Hedges g) and minimal clinically important differences will be reported.
Safety Monitoring Adverse events-including exacerbation of radicular pain, hemodynamic instability during aerobic sessions, or procedure-related complications-are recorded at each visit. An independent physician adjudicates seriousness and relatedness; criteria for withdrawal include VAS ≥ 7 persisting >48 h or cardiovascular red-flags according to American College of Sports Medicine guidelines. A Data Safety Monitoring Sub-committee reviews unblinded safety reports quarterly.
*Knowledge Translation* Results will inform evidence-based guidelines on post-CESI rehabilitation, disseminated via peer-reviewed publication, conference presentation, and integration into continuing professional development modules for physiotherapists. De-identified datasets and analytic code will be deposited in an open repository within 12 months of primary outcome publication, aligning with FAIR data principles and UK Research Councils' open-science policy.
In summary, this rigorously designed trial seeks to delineate whether adjunctive aerobic or motor-control-oriented exercise offers superior and durable benefits over conventional modalities alone in the critical post-injection period for patients with lumbar disc herniation, thereby refining best-practice rehabilitation pathways.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyOther: Conventional Physiotherapy (moist heat, therapeutic ultrasound, TENS) |
| Aerobic Exercise + Conventional Physiotherapy | Experimental | Other: Conventional Physiotherapy, Behavioral: Aerobic Exercise Programme* Behavioral: Aerobic Exercise (treadmill walking) * Other: Conventional Physiotherapy |
| Core-Stabilization Exercise + Conventional Physiotherapy | Experimental | Other: Conventional Physiotherapy, Behavioral: Core-Stabilization Exercise Programme* Behavioral: Core-Stabilisation Exercise * Other: Conventional Physiotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional PhysiotherapyStandard 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). | Other | Aerobic Exercise + Conventional Physiotherapy, Conventional Physiotherapy, Core-Stabilization Exercise + Conventional Physiotherapy |
| Aerobic Exercise ProgrammeSupervised 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. | Behavioural | Aerobic Exercise + Conventional Physiotherapy |
| Core-Stabilization Exercise ProgrammePhased 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. | Behavioural | Core-Stabilization Exercise + Conventional Physiotherapy |
Primary outcome
Change in Pain Intensity (Numeric Rating Scale, 0-10)
Time frame: Baseline; 6 weeks; 3 months; 6 months
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.
5 secondary outcomes
Change in Disability (Oswestry Disability Index, 0-100)
Time frame: Baseline, 6 weeks, 3 months, 6 months
Change in Health-Related Quality of Life (SF-12 Physical Component, 0-100)
Time frame: Baseline, 6 weeks, 3 months, 6 months
Change in Health-Related Quality of Life (SF-12 Mental Component, 0-100)
Time frame: Baseline; 6 weeks; 3 months; 6 months
Change in Lumbar Body Awareness (Fremantle Back Awareness Questionnaire, 0-36)
Time frame: Baseline; 6 weeks; 3 months; 6 months
Return-to-Work Days
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 32613192Fornari M, Robertson SC, Pereira P, Zileli M, Anania CD, Ferreira A, Ferrari S, Gatti R, Costa F. Conservative Treatment and Percutaneous Pain Relief Techniques in Patients with Lumbar Spinal Stenosis: WFNS Spine Committee Recommendations. World Neurosurg X. 2020 Jun 23;7:100079. doi: 10.1016/j.wnsx.2020.100079. eCollection 2020 Jul.
- Results publication: PubMed 38841695Zhang J, Zhang R, Wang Y, Dang X. Efficacy of epidural steroid injection in the treatment of sciatica secondary to lumbar disc herniation: a systematic review and meta-analysis. Front Neurol. 2024 May 22;15:1406504. doi: 10.3389/fneur.2024.1406504. eCollection 2024.
- Results publication: PubMed 25932092Yang H, Liu H, Li Z, Zhang K, Wang J, Wang H, Zheng Z. Low back pain associated with lumbar disc herniation: role of moderately degenerative disc and annulus fibrous tears. Int J Clin Exp Med. 2015 Feb 15;8(2):1634-44. eCollection 2015.
- Results publication: PubMed 38389961Yaman O, Guchkha A, Vaishya S, Zileli M, Zygourakis C, Oertel J. The role of conservative treatment in lumbar disc herniations: WFNS spine committee recommendations. World Neurosurg X. 2024 Feb 13;22:100277. doi: 10.1016/j.wnsx.2024.100277. eCollection 2024 Apr.
- Results publication: PubMed 15129077Yakut E, Duger T, Oksuz C, Yorukan S, Ureten K, Turan D, Frat T, Kiraz S, Krd N, Kayhan H, Yakut Y, Guler C. Validation of the Turkish version of the Oswestry Disability Index for patients with low back pain. Spine (Phila Pa 1976). 2004 Mar 1;29(5):581-5; discussion 585. doi: 10.1097/01.brs.0000113869.13209.03.
- Results publication: PubMed 33969319Wilby MJ, Best A, Wood E, Burnside G, Bedson E, Short H, Wheatley D, Hill-McManus D, Sharma M, Clark S, Baranidharan G, Price C, Mannion R, Hutchinson PJ, Hughes DA, Marson A, Williamson PR. Surgical microdiscectomy versus transforaminal epidural steroid injection in patients with sciatica secondary to herniated lumbar disc (NERVES): a phase 3, multicentre, open-label, randomised controlled trial and economic evaluation. Lancet Rheumatol. 2021 Mar 18;3(5):e347-e356. doi: 10.1016/S2665-9913(21)00036-9. eCollection 2021 May.
- Results publication: PubMed 27327235Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18.
- Results publication: PubMed 9474831Waddell G, Feder G, Lewis M. Systematic reviews of bed rest and advice to stay active for acute low back pain. Br J Gen Pract. 1997 Oct;47(423):647-52.
- Results publication: PubMed 33974132Verheijen EJA, Bonke CA, Amorij EMJ, Vleggeert-Lankamp CLA. Epidural steroid compared to placebo injection in sciatica: a systematic review and meta-analysis. Eur Spine J. 2021 Nov;30(11):3255-3264. doi: 10.1007/s00586-021-06854-9. Epub 2021 May 11.
- Results publication: PubMed 29756333Van Boxem K, Rijsdijk M, Hans G, de Jong J, Kallewaard JW, Vissers K, van Kleef M, Rathmell JP, Van Zundert J. Safe Use of Epidural Corticosteroid Injections: Recommendations of the WIP Benelux Work Group. Pain Pract. 2019 Jan;19(1):61-92. doi: 10.1111/papr.12709. Epub 2018 Jul 2.
- Results publication: PubMed 36453667Taspinar G, Angin E, Oksuz S. The effects of Pilates on pain, functionality, quality of life, flexibility and endurance in lumbar disc herniation. J Comp Eff Res. 2023 Jan;12(1):e220144. doi: 10.2217/cer-2022-0144. Epub 2022 Dec 1.
- Results publication: PubMed 35730511Soylu C, Kutuk B. Reliability and Validity of the Turkish Version of SF-12 Health Survey. Turk Psikiyatri Derg. 2022 Summer;33(2):108-117. doi: 10.5080/u25700. English, Turkish.
- Individual participant dataSharing planned: Yes. A de-identified participant-level dataset and accompanying data dictionary will be deposited in an open-access repository (e.g., Open Science Framework) within 12 months of publication of the primary results, accessible to qualified researchers under a CC-BY license.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Physiotherapy, Aerobic Exercise Programme and Core-Stabilization Exercise Programme in people with Intervertebral Disc Displacement and Low Back Pain, run by Çankırı Karatekin University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ceyhun Türkmen, PhD (+90 376 218 95 00 ext. 3168, ceyhunturkmen@karatekin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (Numeric Rating Scale, 0-10) (time frame: Baseline; 6 weeks; 3 months; 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06956664, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.