Effectiveness of Radial Extracorporeal Shockwave Therapy in Patients with Acute Low Back Pain-Randomized Controlled Trial

Tobias Lange, Niklas Deventer, Georg Gosheger, Lukas P Lampe, Sebastian Bockholt, Albert Schulze Boevingloh, Tobias L Schulte, Tobias Lange, Niklas Deventer, Georg Gosheger, Lukas P Lampe, Sebastian Bockholt, Albert Schulze Boevingloh, Tobias L Schulte

Abstract

The aim of this study was to investigate the effect of radial extracorporeal shockwave therapy (rESWT) primarily on acute lumbar back pain (aLBP), and secondarily on physical function and quality of life. This randomized, placebo-controlled, single-blinded trial with 12-week follow-up (FU) randomized 63 patients with aLBP 1:1 into two groups receiving either rESWT (intervention) or sham rESWT (placebo) with a manipulated shockwave head not delivering any shockwaves. Both, rESWT and sham procedure were carried out eight times for four weeks. Both groups received additional analgesics and physiotherapy twice a week. Primary patient-reported outcome measure (PROM) was the visual analogue scale for aLBP (VAS-LBP). Secondary PROMs included the Oswestry disability index (ODI), Roland and Morris Disability Questionnaire (RDQ), EuroQol EQ-5D-3L, and the Beck Depression Index (BDI-II). Primary endpoint was a between-arm comparison of mean changes in VAS-LBP from baseline to final FU. At randomization, there were no differences between the two groups in relation to age and PROMs. Both groups showed significant improvement in all PROMs at final FU. VAS-LBP declined by 60.7% (p < 0.001) in the intervention and by 86.4% (p < 0.001) in the sham group. The intervention group showed significantly less pain relief after 4 and 12 weeks. The EQ-5D submodality pain showed significantly inferior results for the intervention (1.5 (0.58)) compared to the sham group (1.1 (0.33)) (p < 0.014) after eight weeks. No significant intergroup differences were observed for RDQ, ODI or BDI-II. Additional rESWT alongside conventional guideline therapy in aLBP does not have any significant effects on pain intensity, physical function, or quality of life. To the best of our knowledge, this is the first study with a high level of evidence reporting the efficacy of rESWT in aLBP treatment and will be a future basis for decision-making.

Keywords: acute; clinical outcome; low back pain; radial shockwave therapy; randomized controlled trial (RCT); spine.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Consolidated standards of reporting trials (CONSORT) 2010 flow diagram for patient selection.
Figure 2
Figure 2
The pain level according to the visual analogue scale for low back pain (VAS-LBP; mean (SD)) for the two groups (intervention vs. placebo) at the eight different time points. Asterisks (*) indicate a significant difference (p < 0.05).
Figure 3
Figure 3
Physical function according to the Oswestry disability index (ODI; mean (SD)) for the two groups (intervention vs. placebo) at the eight different time points.

References

    1. Schmidt C.O., Raspe H., Pfingsten M., Hasenbring M., Basler H.D., Eich W., Kohlmann T. Back pain in the German adult population: Prevalence, severity, and sociodemographic correlates in a multiregional survey. Spine. 2007;32:2005–2011. doi: 10.1097/BRS.0b013e318133fad8.
    1. Casser H.-R., Seddigh S., Rauschmann M. Acute Lumbar Back Pain: Investigation, Differential Diagnosis, and Treatment. Dtsch. Arztebl. Int. 2016;113:223–234. doi: 10.3238/arztebl.2016.0223.
    1. Babatunde O.O., Jordan J.L., Van der Windt Danielle A., Hill J.C., Foster N.E., Protheroe J. Effective treatment options for musculoskeletal pain in primary care: A systematic overview of current evidence. PLoS ONE. 2017;12:e0178621. doi: 10.1371/journal.pone.0178621.
    1. Robert Koch Institut Gesundheit in Deutschland. Gesundheitsberichterstattung des Bundes.: Gemeinsam Getragen von RKI und Destatis. [(accessed on 23 November 2021)]. Available online: .
    1. Bundesärztekammer (BÄK) Kassenärztliche Bundesvereinigung (KBV) Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften Nationale VersorgungsLeitlinie Nicht-spezifischer Kreuzschmerz–Langfassung. [(accessed on 23 November 2021)]. Available online: .
    1. Wei W., Tang H.-Y., Li Y.-Z., Wang T.-S. Effectiveness of extracorporeal shock wave for low back pain: A protocol of systematic review. Medicine. 2019;98:e14511. doi: 10.1097/MD.0000000000014511.
    1. Barker K.L., Elliott C.J., Sackley C.M., Fairbank J.C.T. Treatment of chronic back pain by sensory discrimination training. A Phase I RCT of a novel device (FairMed) vs. TENS. BMC Musculoskelet. Disord. 2008;9:97. doi: 10.1186/1471-2474-9-97.
    1. Seco J., Kovacs F.M., Urrutia G. The efficacy, safety, effectiveness, and cost-effectiveness of ultrasound and shock wave therapies for low back pain: A systematic review. Spine J. 2011;11:966–970. doi: 10.1016/j.spinee.2011.02.002.
    1. Celik A., Altan L., Okmen B.M. The Effects of Extracorporeal Shock Wave Therapy On Pain, Disability And Life Quality Of Chronic Low Back Pain Patients. Altern. Ther. Health Med. 2020;26:54–60.
    1. Notarnicola A., Maccagnano G., Gallone M.F., Mastromauro L., Rifino F., Pesce V., Covelli I., Moretti B. Extracorporeal shockwave therapy versus exercise program in patients with low back pain: Short-term results of a randomised controlled trial. J. Biol. Regul. Homeost. Agents. 2018;32:385–389.
    1. Chaussy C., Brendel W., Schmiedt E. Extracorporeally induced destruction of kidney stones by shock waves. Lancet. 1980;2:1265–1268. doi: 10.1016/S0140-6736(80)92335-1.
    1. Kertzman P., Császár N.B.M., Furia J.P., Schmitz C. Radial extracorporeal shock wave therapy is efficient and safe in the treatment of fracture nonunions of superficial bones: A retrospective case series. J. Orthop. Surg. Res. 2017;12:164. doi: 10.1186/s13018-017-0667-z.
    1. Speed C. A systematic review of shockwave therapies in soft tissue conditions: Focusing on the evidence. Br. J. Sports Med. 2014;48:1538–1542. doi: 10.1136/bjsports-2012-091961.
    1. Crupnik J., Silveti S., Wajnstein N., Rolon A., Vollhardt A., Stiller P., Schmitz C. Is radial extracorporeal shock wave therapy combined with a specific rehabilitation program (rESWT + RP) more effective than sham-rESWT + RP for acute hamstring muscle complex injury type 3b in athletes? Study protocol for a prospective, randomized, double-blind, sham-controlled single centre trial. J. Orthop. Surg. Res. 2019;14:234.
    1. Torgerson D.J., Roberts C. Understanding controlled trials. Randomisation methods: Concealment. BMJ. 1999;319:375–376. doi: 10.1136/bmj.319.7206.375.
    1. Siemonsma P.C., Walker M.F. Practical guidelines for independent assessment in randomized controlled trials (RCTs) of rehabilitation. Clin. Rehabil. 1997;11:273–279. doi: 10.1177/026921559701100402.
    1. Wheaton L., Pope J. The minimally important difference for patient-reported outcomes in spondyloarthropathies including pain, fatigue, sleep, and Health Assessment Questionnaire. J. Rheumatol. 2010;37:816–822. doi: 10.3899/jrheum.090086.
    1. Lord B.A., Parsell B. Measurement of pain in the prehospital setting using a visual analogue scale. Prehosp. Disaster. Med. 2003;18:353–358. doi: 10.1017/S1049023X0000131X.
    1. Calvert M., Blazeby J., Altman D.G., Revicki D.A., Moher D., Brundage M.D. Reporting of patient-reported outcomes in randomized trials: The CONSORT PRO extension. JAMA. 2013;309:814–822. doi: 10.1001/jama.2013.879.
    1. Zambito Marsala S., Pistacchi M., Tocco P., Gioulis M., Fabris F., Brigo F., Tinazzi M. Pain perception in major depressive disorder: A neurophysiological case-control study. J. Neurol. Sci. 2015;357:19–21. doi: 10.1016/j.jns.2015.06.051.
    1. Lee S., Lee D., Park J. Effects of extracorporeal shockwave therapy on patients with chronic low back pain and their dynamic balance ability. J. Phys. Ther. Sci. 2014;26:7–10. doi: 10.1589/jpts.26.7.
    1. Han H., Lee D., Lee S., Jeon C., Kim T. The effects of extracorporeal shock wave therapy on pain, disability, and depression of chronic low back pain patients. J. Phys. Ther. Sci. 2015;27:397–399. doi: 10.1589/jpts.27.397.
    1. Wang C.-J. Extracorporeal shockwave therapy in musculoskeletal disorders. J. Orthop. Surg. Res. 2012;7:11. doi: 10.1186/1749-799X-7-11.
    1. Wang C.-J. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med. J. 2003;26:220–232.
    1. Saggini R., Di Stefano A., Saggini A., Bellomo R.G. Clinical application of shock wave therapy in musculoskeletal disorders: Part I. J. Biol. Regul. Homeost. Agents. 2015;29:533–545.
    1. Schmitz C., Császár N.B., Milz S., Schieker M., Maffulli N., Rompe J.D., Furia J.P. Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: A systematic review on studies listed in the PEDro database. Br. Med. Bull. 2015;116:115–138. doi: 10.1093/bmb/ldv047.
    1. Saggini R., Di Stefano A., Saggini A., Bellomo R.G. Clinical application of shock wave therapy in musculoskeletal disorders: Part II related to myofascial and nerve apparatus. J. Biol. Regul. Homeost. Agents. 2015;29:771–785.

Source: PubMed

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