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**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:
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Physiotherapy | Active Comparator | Other: Conventional Physiotherapy (moist heat, therapeutic ultrasound, TENS) |
|
| Aerobic Exercise + Conventional Physiotherapy | Experimental |
|
|
| Core-Stabilization Exercise + Conventional Physiotherapy | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 weeks, 3 months, 6 months |
| Change in Health-Related Quality of Life (SF-12 Physical Component, 0-100) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Related to Exercise or CESI | Unit of Measure: number of participants with ≥1 event Description: Musculoskeletal, cardiovascular, or injection-related adverse events, coded per CTCAE v5.0. Both incidence and narrative description will be provided. | Throughout 6-week intervention and 6-month follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ceyhun Türkmen, PhD | Contact | +90 376 218 95 00 | 3168 | ceyhunturkmen@karatekin.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Çankırı Karatekin University | Active, not recruiting | Çankırı | Turkey (Türkiye) | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32613192 | Background | 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. | |
| 38841695 |
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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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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D017116 | Low Back Pain |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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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.
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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.
|
| 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. |
|
| 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. |
|
Unit of Measure: points (0-100) Description: Short-Form-12 v2 Physical Component Summary (PCS); higher scores represent better quality of life. |
| 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. | 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. | 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. | Up to 6 months |
| Çankırı State Hospital |
| Recruiting |
| Çankırı |
| Turkey (Türkiye) |
|
| Çankırı State Hospital | Recruiting | Çankırı | Turkey (Türkiye) |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |