01/06/2025
Treatment of Sciatica and Lumbar Radiculopathy with an Intervertebral Foramen Opening Protocol: Pilot Study in a Hospital Emergency and In-patient Setting 💡
🦵Sciatica and lumbar radiculopathy are debilitating conditions often caused by lumbar disc herniation, leading to nerve root compression, pain, and functional impairment. Sciatica is characterized by radiating leg pain, often accompanied by sensory or motor deficits, with a prevalence estimated at 1.6–43% depending on diagnostic criteria (Konstantinou & Dunn 2008). Lumbar radiculopathy, commonly due to disc herniation, results in nerve root irritation or compression, impacting quality of life and often requiring medical intervention (Breivik et al. 2013). Conservative treatments, including physical therapy, medication, and manual therapy, are typically first-line approaches, but evidence on their efficacy varies (Fernandez et al. 2015).
↕️ The intervertebral foramen opening protocol, which involves lumbar flexion and contralateral side bending to reduce nerve root pressure, is a novel approach not extensively studied (Shacklock 2005). Compared with extension, foramen opening up to 44% may be produced with flexion (Inufusa et al. 1996; Kubosch et al. 2015; Morish*ta et al. 2006; Nowicki et al. 1996; Schmid et al. 1999; Zhong et al. 2015) and 8% with contralateral flexion (Fujiwara et al. 2001) including patients with disc herniation.
📘 A pilot study by Shacklock et al. (2023, https://pubmed.ncbi.nlm.nih.gov/35253599/) evaluates the feasibility, safety, and preliminary efficacy of this protocol in a hospital setting for patients with sciatica and lumbar radiculopathy due to disc herniation.
😷 This randomized prospective cohort pilot study was conducted in an emergency hospital setting to assess a static intervertebral foramen opening protocol for treating sciatica and lumbar radiculopathy caused by disc herniation.
▶️ Methods
👫Participants: Twenty patients were randomized into control (n=10) and experimental (n=10) groups based on odd/even case numbers. Inclusion required MRI-confirmed disc herniation, electrophysiological deficits, positive straight leg raise (SLR), and leg pain.
❌ Exclusion criteria included multisegmental disc herniation, significant comorbidities, and inability to perform the protocol.
🩻Diagnosis: MRI was performed within 3 days of admission to confirm disc herniation, classified using the Michigan State University system for size (small, moderate, large) and location (midline, paramedian, lateral). Electrophysiological testing assessed nerve root sensory and motor deficits.
▶️ Interventions:
👉 Control Group: Received standard care, including oral dexamethasone (up to 12 mg/day for 5 days), tramadol, and optional medications (ibuprofen, indomethacin, sodium diclofenac, diazepam, pregabalin). Patients were instructed to walk as tolerated, perform forward bending, avoid backward bending, and not lie supine.
👉 Experimental Group: Received standard care plus the foramen opening protocol, involving lumbar flexion and contralateral side bending in a side-lying position (s. picture), guided by a physiotherapist (Shacklock, 2005). The protocol started with 1-minute holds, 5 repetitions, 5 times daily (25 minutes/day) for days 0–5, increasing to 2-minute holds from day 6, with up to 10 sets daily by day 9+.
Compliance and Monitoring: A physiotherapist ensured compliance through twice-daily visits, supervising and correcting technique. Non-compliant patients would be excluded, but all participants adhered to the protocol.
▶️ Outcome Measures: Assessed at admission and discharge, including:
✅Pain: Visual Analog Scale (VAS) for lumbar and lower limb pain (0–10).
✅ Disability: EuroQol 5D5L (EQ-5D-5L, 0–1) (EuroQol Group, 1990) and Oswestry Disability Index (ODI, 0–100).
✅Quality of Life: EQ VAS (0–100).
✅Function: Symptomatic SLR range of motion (degrees).
✅ Hospital stay duration and medication consumption.
▶️ Results
📊Baseline Characteristics: No significant differences existed between groups in age, gender, height, weight, or most outcome variables, except for ODI (p=0.047), attributed to scaling artifact. All patients had disc herniations (60% large in experimental, 80% in control), with electrophysiological deficits in 90% of experimental and 50% of control patients.
📊Pain and Disability: The experimental group showed significant improvements in all outcome variables (VAS lumbar, VAS lower limb, SLR, EQ-5D-5L, EQ VAS, Oswestry, ODI) at discharge (p0.8), compared to control group effect sizes of 0.09–0.53 (small to medium) (Table 5).
📊MCID: More experimental group patients met MCID thresholds for pain (7 vs. 3 for lumbar, 9 vs. 5 for leg), EQ-5D-5L (9 vs. 3), EQ VAS (9 vs. 8), and Oswestry (9 vs. 1).
📊Medication Use: Experimental patients consumed 21% of total medication (230 mg/patient/day) vs. 79% for controls (864 mg/patient/day), with notably lower opioid (tramadol) use (23.5 vs. 70.5 mg/patient/day).
📊 Hospital Stay: Mean hospital stay was similar (8.8 days experimental vs. 8.5 days control, p=0.83).
📊 Safety: No adverse events or symptom worsening occurred in the experimental group; one control patient reported increased leg pain (VAS 6 to 8).
▶️ Discussion
✅ Efficacy: The foramen opening protocol, combined with standard care, yielded greater improvements in pain, disability, and quality of life compared to standard care alone. The protocol’s logic of reducing nerve root pressure (Shacklock, 2005) may explain these outcomes, though direct evidence of reduced foraminal pressure was not measured.
✅ Compliance: The hospital setting facilitated high compliance, likely due to close monitoring and a controlled environment, contrasting with potential outpatient challenges (e.g., daily activities, work).
🚫Limitations: The small sample size (n=20) limits generalizability, and the study design (A vs. A+B) cannot rule out the effect of additional attention in the experimental group. Lack of long-term follow-up and mechanistic evidence (e.g., reduced foraminal pressure) are additional limitations.
✅ Safety and Feasibility: The protocol was safe, easy to teach, and feasible for home use, potentially reducing treatment costs and enhancing patient self-efficacy.
▶️ Conclusions
🔑 The pilot study demonstrated that the intervertebral foramen opening protocol, when added to standard care, significantly improved pain, disability, and quality of life in patients with sciatica and lumbar radiculopathy, with reduced opioid consumption and no adverse effects. The hospital setting supported feasibility and compliance, and the methods (MRI, electrophysiology, outcome measures) are suitable for further investigation.
Future RCTs should include larger samples (approximately 65 patients), flexible assessment schedules, long-term follow-up, and comparisons with other treatments to confirm efficacy and explore mechanisms.
📒 References
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Fernandez, M., Hartvigsen, J., Ferreira, M., Refshauge, K., Machado, M., Lemes, I., Maher, C., & Ferreira, P. (2015). Advice to stay active or structured exercise in the management of sciatica: A systematic review and meta-analysis. Spine, 40(18), 1457-1466. doi:10.1097/BRS.0000000000001036
Fujiwara, A., An, H., Lim, T., Haughton, V. (2001). Morphologic changes in the lumbar intervertebral foramen due to flexion-extension, lateral bending, and axial rotation:An in vitro anatomic and biomechanical study. Spine 26: 876–882. doi:10.1097/00007632-200104150-00010.
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Zhong, W., Driscoll, S., Tsai, T. Y., Wang, S., Mao, H., Cha, T., Wood, K., & Li, G. (2015). In-vivo dynamic changes of dimensions in the lumbar intervertebral foramen. Spine Journal, 15(7), 1653-1659. doi:10.1016/j.spinee.2015.03.015
