Shockwave Therapy Clinical Evidence

RESEARCH OVERVIEW SHOCK WAVE THERAPY

This interactive presentation gives an overview of published research on radial shock wave (RSW) and focused shock wave (FSW) therapy

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WORKING MECHANISMS LABORATORY STUDIES

CLINICAL STUDIES SYSTEMATIC REVIEWS

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Working Mechanisms

How Does Shock Wave Therapy Work?

Biological

In general

D’Agostino 2015

Poenaru 2022

Waugh 2015

Blood supply

Yan 2008

Anti-inflammatory

Ge 2022

More specifically

Pathophysiological

Al-Abbad 2020

Tissue healing (meniscal)

Huang 2024

d’Agostino 2015 | Biological effects

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d'Agostino MC, Craig K, Tibalt E, Respizzi S. Shock wave as biological therapeutic tool: From mechanical stimulation to recovery and healing, through mechanotransduction. Int J Surg. 2015 Dec;24(Pt B):147-53.

Review article. • The mechanical stimulus of shockwaves is a trigger that activates a series of cellular events that have a positive effect on cell metabolism and cell cycle. • Basic science has shown that shockwaves induce proliferation, migration and differentiation of stem cells, which significantly contribute to tissue healing and regeneration. • Tenocytes are very sensible to mechanical stimulations. • Bone cells are also sensible to mechanotransduction - shockwaves are an important therapeutic tool for enhancing osteoregenerative processes. The clinical efficacy of shockwaves in bone healing is tightly related to its ability to induce neovascularization and matrix remodelling “in vivo”. • There is increasing evidence that shockwaves act as “immunomodulator” in wound healing and tissue regeneration, mainly through an anti-inflammatory strategy. • Some experimental studies have shown that shockwaves could reduce capsule formation and may induce fibrotic tissue remodelling/resorption - they help restoration of tissue integrity. • Shockwaves can also interfere with the nervous system and neurophysiological processes and produce an analgesic effect, and also reduce hypertonia in spastic muscles.

Key message Through the principle of 'mechanotransduction', shockwaves can positively influence the chain of biological reactions that lead tissue regeneration and healing.

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Pubmed

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Poenaru 2022 | Biological effects

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Poenaru D, Sandulescu MI, Cinteza D. Biological effects of extracorporeal shockwave therapy in tendons: A systematic review. Biomed Rep. 2022 Dec 29;18(2):15.

Systematic review. • 23 articles were included on ESWT application in human or animal tendons, either in vivo or in vitro. Outcomes: • ESWT doses and the definition of the optimal dose, • Neoangiogenesis, • Histopathologic changes, • Biochemical changes, • Mechanical properties. Results: this systematic review outlines a large spectrum of biological effects. • An optimal dose is adapted for each species and each tendon; exceeding the optimal dose may lead to structural injury. • The biological effects may be grouped into neovascularization induction with extensive capillary formation from the peritendinous structures, cellularity (tenocytes activation and proliferation) and extracellular matrix changes, metalloprotease and cytokine modulation, as well as lubricin production. • As a result, the remodelled tendon displays improved biomechanical properties to resist stress.

Key message: Scientific papers agree on several structural alterations induced by ESWT that promote tendon healing. The therapy acts on both cellular and extracellular compartments of the tendon structure and results in improved biomechanical tendon properties.

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Waugh 2015 | Biological effect

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Waugh CM, Morrissey D, Jones E, Riley GP, Langberg H, Screen HR. In vivo biological response to extracorporeal shockwave therapy in human tendinopathy. Eur Cell Mater. 2015 May 15;29:268-80

In vivo experimental study. 13 healthy individuals and 6 patients with patellar or Achilles tendinopathy received a single session of radial ESWT to the mid-portion of the tendon. Outcomes The study investigated the acute response of inflammatory cytokines associated with mechanical loading, repair processes and tenocyte health and also matrix metalloproteases (MMPs), which are implicated in the homeostasis of tissue regeneration. • Inflammatory cytokines (IL- 1β, IL -2, IL-6 and IL-8) • Matrix metalloproteinase activity Results • IL-6 and IL-8 concentrations were elevated immediately after ESWT and remained significantly elevated for four hours post-ESWT (p < 0.001). • Pro-forms of MMP-2 and -9 also increased after ESWT (p < 0.003) •

Key message The present study demonstrates an immediate and significant increase in some inflammatory and metabolic markers in response to ESWT in both healthy and pathological tendons. This suggest that the mechanical stimulus provided by ESWT might aid the initiation of tendon regeneration in tendinopathy by promoting pro- inflammatory and catabolic processes that are associated with removing damaged matrix constituents.

The biological response to ESWT treatment could be differentiated between possible responders and non- responders

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Concentration of interleukin (IL)-6 and 8 before and 1, 2, 3 and 4 h after ESWT in healthy (filled diamonds, n = 10) and tendinopathic (open diamonds, n = 10) tendons. IL-6 and IL-8 demonstrate significantly elevated concentrations post-ESWT when compared with pre-treatment concentrations and remained significantly elevated 4 h post- ESWT. * Different from baseline value (p < 0.05); † different from b aseline (p < 0.1); § different from post 1 h (p < 0.05); ‡ different from post 1 h (p < 0.1); # different from post 2 h (p < 0.05). Black and grey symbols refer to patients and healthy groups, respectively.

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Yan 2008 | Effect on blood supply

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Yan X, Zeng B, Chai Y, Luo C, Li X. Improvement of blood flow, expression of nitric oxide, and vascular endothelial growth factor by low-energy shockwave therapy in random-pattern skin flap model. Ann Plast Surg. 2008 Dec;61(6):646-53.

Randomised controlled animal laboratory study on 84 adult male Sprague- Dawley rats. The ischemic portion of a skin flap was treated with (treatment group, n=42) or without (control group, n=42) ESWT.

Results: • Blood perfusion , expression of nitric oxide ( NO ) and vascular endothelial growth factor ( VEGF ), vasodilatation of pre-existing vessels were significantly promoted in the ESWT group compared to the control group at early postoperative stage. • Neovascularization were significantly promoted in the ESWT group compared to the control group at late stage. • Flap survival was signif. better in treatment group compared to the control group.

Key message: ESWT can significantly improve blood perfusion of ischemic flaps postoperatively and augment flap survival.

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• Around 50% higher survival area and survival rate in the treatment group.

Conclusion: ESWT can improve skin flap surviving rate through enhanced vasodilatation at early postoperative stage and neovascularization at late stage via modulation of angio-active factors expression.

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Ge 2022 | Anti-inflammatory effect

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Ge R, Zhu Q, Liu D, Zhang Q, Jiang S, Yu X, Shu J, Gao F, Guo J, Chen S, Gao B. Quantitative proteomics reveals potential anti-inflammatory protein targets of radial extracorporeal shock wave therapy in TNF- α -induced model of acute inflammation in primary human tenocytes. Heliyon. 2022 Dec 2;8(12):e12008.

In vitro laboratory study on human tenocytes. • The present study demonstrated that rESWT reversed the TNFα -induced decline in primary human tenocyte proliferation and increase in IL- 1β levels. • Based on the findings in vitro, the authors speculated that ITGA2, SELS, and NLRC4 are potential anti-inflammatory protein targets of rESWT in a TNF- α -induced model of acute inflammation in primary human tenocytes. • The authors further hypothesize that rESWT can prevent tendinopathy from progressing to the chronic stage by regulating the inflammatory response in the acute or subacute stages, which may open new opportunities for clinical treatment. • Low-to moderate-energy rESWT resulted in fewer immediate cytodestructive effects and greater stimulation of cell proliferation, which are in agreement with previous findings.

Key message RSW was shown in-vitro to have an anti-inflammatory effect in tendinopathies and may prevent tendinopathy from progressing to the chronic stage by regulating the inflammatory response in the acute or subacute stages. Pubmed iEnovis

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Al-Abbad 2020 | Pathophysiology

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Al-Abbad H, Allen S, Morris S, Reznik J, Biros E, Paulik B, Wright A. The effects of shockwave therapy on musculoskeletal conditions based on changes in imaging: a systematic review and meta-analysis with meta-regression. BMC Musculoskelet Disord. 2020 Apr 28;21(1):275.

Systematic review with meta-analysis including 63 prospective clinical trials evaluating the effectiveness of shock wave treatment (SWT) based on changes in imaging outcomes. Imaging outcomes showed SWT produced a reduction of: • the calcium deposit diameter in rotator cuff tendinitis

• plantar fascia thickness in plantar fasciitis • the lesion size in femoral head osteonecrosis

These results provide preliminary evidence for the influence SWT may have on underlying pathophysiological processes, however the quality of evidence is low partly due to inconsistent imaging methods and reporting.

Key message Imaging outcomes showed shock wave treatment altered the morphology of musculoskeletal conditions, potentially reflecting changes in underlying pathophysiological processes.

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Huang 2024 | Tissue repair | RSW

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Huang M, Shao H, Zhang S, Gao H, Feng S, Sun L, Yu C, Du X, Chen J, Li Y. Single-Dose Radial Extracorporeal Shock Wave Therapy Modulates Inflammation During Meniscal Tear Healing in the Avascular Zone. Am J Sports Med. 2024 Mar;52(3):710-720.

Controlled laboratory study on rats. Methods: Avascular tears were induced in the medial meniscus (MM) of 72 Sprague-Dawley rats. One week postoperatively, the rats received a single session of RSWT with a Power+ handpiece (ESWT group; n = 36) or with a fake handpiece (sham-ESWT group; n = 36). Results • Histological and imaging showed the ESWT group had significantly better meniscal healing scores than the sham-ESWT group at 4 and 8 weeks postoperatively. • Immunohistological evaluation showed ESWT significantly modulated the inflammation process : • The IL- 1β level was significantly higher in the sham -ESWT group than in the ESWT group at 2 and 8 weeks. • The IL-6 level was significantly lower in the sham-ESWT group than in the ESWT group at 2 and 4 weeks but higher at 8 weeks. • Histological evaluation of cartilage showed a higher degree of cartilage degeneration in the sham-ESWT group and according to the OARSI osteoarthritis cartilage histopathology assessment system, the sham group had significantly higher osteoarthritis scores than the ESWT group at 4 and 8 wks.

Key message Radial ESWT can be considered a potential option for improving meniscal tear healing in the avascular zone because of its ability to modulate inflammation.

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(F) Comparison of meniscal healing score at the same time points between groups.

(E) Meniscal healing score changing over time.

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Clinical studies & reviews

Yellow border = study with Chattanooga device

FSW Clin. studies

RSW Clin. studies

SYSTEMATIC REVIEWS

MF Trigger Points

Avendaño 2024

Kartaloglu 2023

Frozen shoulder

Stroke shoulder

Zhang 2023

Zhang 2022

Shoulder tendinopathy

Wu 2017

Abo Al-Kair 2021

Back Pain

Walewicz 2020

Wu 2023

Nambi 2022

Liu 2022

Epicondylitis

Vongvachvasin 2024

Carpal Tunnel

Sağlam 2022

Rashad 2020

Carpal Tunnel

Xie 2022

Femoral head osteonecrosis

Greater Trochanteric Pain

Wheeler 2022b

Wheeler 2022a

Shi 2024

Knee OA

Tang 2024

Silva 2023

Knee OA

Ko 2022

Liu 2022

ACLR

Zhang 2023

Weninger 2023

Medial Tibial Stress Syndrome

Ou-Yang 2023

Spasticity

Leng 2021

Garcia 2017

Abdelkader 2021

Achilles Tendinopathy

Robinson 2021

Paantjens 2022

Robinson 2021

Achilles Tendinopathy

Plantar Fasciitis

Cortéz 2024

Plantar Fasciitis

Lou 2017

Wheeler 2022

Gollwitzer 2015

Important notice, please read

Notice:

Please note that:

• Publications with Chattanooga devices may be on a model that is not available in the EU. • The results/ findings/ indications evaluated in the studies are not necessarily applicable or included in the intended use of the Chattanooga devices available in the EU and off-label use is discouraged.

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Kartaloglu 2023 | Myofascial TPs | RSW

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Kartaloglu IF, Kus AA. Evaluation of Radial Extracorporeal Shock Wave Therapy on Treatment-Resistant Trigger Points Using Sonographic Shear Wave Elastography. J Coll Physicians Surg Pak. 2023 Oct;33(10):1159-1164.

Experimental study – no control group (41 patients; 70 TPs in upper trapezius) Subjects received between 1 and 5 weekly RSW sessions (1500 pulses, 8 Hz, 1.5 bar ) • Until VAS <2 or max. 5 sessions Results Sifnificant improvements compared to pre-treatment of: • Pain (VAS) post-treatment and at 3m follow-up • Disability (NDI) post-treatment • Tissue stiffness (shear modulus measured with US shear wave elastography) post-treatment The average number of treatment sessions was 3

Key message ESWT is a non-invasive, safe, and tolerable therapy option for reducing pain, improving function, and reducing tissue stiffness in patients with treatment-resistant MTrPs. Pain improvement was maintained up to 3 months after treatment.

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Signif. Difference compared to pre-treatment

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Avendaño 2024 | Myofascial TPs | Review

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Avendaño-López C, Megía-García Á, Beltran-Alacreu H, Serrano-Muñoz D, Arroyo-Fernández R, Comino-Suárez N, Avendaño-Coy J. Efficacy of Extracorporeal Shockwave Therapy on Pain and Function in Myofascial Pain Syndrome: A Systematic Review and Meta-analysis of Randomized Clinical Trials. Am J Phys Med Rehabil. 2024 Feb 1;103(2):89-98.

Systematicreview and Meta-analysis 27 studies were included - total of 1377 participants. • 18 RSW / 9 FSW • 22 cervical & shoulder / 5 other areas Results Statistically and clinically significant improvements with ESWT compared to control of • Pain (VAS) • Pain Pressure Threshold (PPT) • Function Comparedto other treatments • Significantly better than Ultrasound • No differencewith corticosteroidinjections FSW protocols (ranges) • Total number of treatment sessions in most studies was 3 to 4. • RSW 1.2-4 bar; 300-1500 pulses; 1-20 Hz • FSW 0.056 - 0.26 mJ/mm²; 400-700 pulses; 1-10 Hz

Key message ESWT is more effective than control treatments and ultrasound for relieving pain and improving function in MFP. It is equally effective as dry needling and corticosteroid injections while less invasive.

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Effect on pain measured by VAS

Significantly more improvementof pain VAS with ESWT versus control. The MD (Mean Difference) was also clinically relevant.

When the diamond doesn’t cross the vertical zero-line, this means the differencecompared to control is statistically significant.

Effect on functionality

Significantly more improvementof function with ESWT versus control.

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Zhang 2022 | Frozen Shoulder | Review

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Zhang R, Wang Z, Liu R, Zhang N, Guo J, Huang Y. Extracorporeal Shockwave Therapy as an Adjunctive Therapy for Frozen Shoulder: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2022 Feb 4;10(2):23259671211062222.

Systematic review and Meta-analysis 20 studies that compared ESWT plus routine treatments to controls who received routine treatment only were included in the meta-analysis. Results Significantly better outcomes with ESWT as an adjunct to other treatments compared to control for • Immediate and short-term (<3m) pain relief • Immediate function improvement For long-term analgesia (> 3m) the heterogeneity between the studies was too high for reliable conclusions.

Key message ESWT provides immediate improvement of pain and function in patients with frozen shoulder.

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Pain (VAS)

When the diamond doesn’t cross the vertical zero-line, this means the difference compared to control is statistically significant.

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Zhang 2023 | Stroke shoulder | Review

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Zhang T, Zhang C. Extracorporeal shock wave therapy for shoulder pain after stroke: A systematic review and meta-analysis. Clin Rehabil. 2023 Jan 22:2692155231152134. doi: 10.1177/02692155231152134. Epub ahead of print.

Systematic review and Meta-analysis • 18 RCTs (total 1248 subjects) were included Results:

Compared to control group (who received conventional PT and/or sham shock wave), ESWT group (who received ESWT alone or in combination with conventional PT) had significantly better: • Visual analogue scale (VAS) scores for pain, • Fugl-Meyer assessment upper extremity scale for function, • Active range of motion (AROM), • Functionalcomprehensive assessment (FCA) scores for activities of daily living (ADL). Recommended treatment parameters included: • Energy flux density ranges from 0.06 to 0.25 mJ/mm2 • ≥ 2000 shocks per treatment; • Intervention duration between 2 and 4 weeks.

Key message: ESWT is an effective treatment for shoulder pain after stroke, both alone and in addition to conventional treatment. The ESWT improves pain levels, motor function, active mobility, shoulder function, and ADL better than conventional treatment in patients with shoulder pain after stroke.

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Pain (VAS)

Function (Fugl)Meyer)

AROM (B) and FCA (C)

When the diamond doesn’t cross the vertical zero-line, this means the difference compared to control is statistically significant.

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Wu 2017 | Shoulder tendinopathy | Review

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Wu YC, Tsai WC, Tu YK, Yu TY. Comparative Effectiveness of Nonoperative Treatments for Chronic Calcific Tendinitis of the Shoulder: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials. Arch Phys Med Rehabil. 2017 Aug;98(8):1678-1692.e6.

SystematicReview& Meta-analysis • 14 studies, 1105 subjects • Modalities compared: RSW, F-SW, Ultrasound guided needling (UGN), Therapeutic Ultrasound, TENS. Results • Pain reduction (8 studies) • The modality that was most likely to be ranked the best in pain reduction was UGN (94.2%), followed by RSW and H-FSW. • Resorption of calcifications (14 studies) • The treatment most likely to be ranked the best in achieving complete resolution of calcific deposition was UGN (93.9%), followed by RSW and H-FSW • Functional improvement (7 studies) • The treatment most likely to be ranked the best in the CMS was H-FSW (94.3%)

Key message Based on this meta-analysis, RSW therapy is the second best option (after ultrasound guided needling) for pain decrease and calcifications resorption. FSW therapy is the first choice for functional improvement.

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Probability of being best treatment for VAS

Probability of being best treatment for function (CMS)

Probability of being best treatment for Calcification resorption

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Abo Al-Khair 2021 | Shoulder tendinop. | RSW/FSW

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Abo Al-Khair MA, El Khouly RM, Khodair SA, Al Sattar Elsergany MA, Hussein MI, Eldin Mowafy ME. Focused, radial and combined shock wave therapy in treatment of calcific shoulder tendinopathy. Phys Sportsmed. 2021 Nov;49(4):480-487.

Randomised comparative study 45 subjects were randomised to receive 4 weekly sessions • FSW, 1500 shocks, 0.3 mJ/mm², 4 Hz (group I) • RSW, 2000 shocks, 2.5 bar, 10 Hz (group II) • Combined RSW + FSW (group III) Results • Significant improvement in shoulder pain, active ROM and shoulder function (shoulder disability questionnaire SDQ) at 1 week after the end of treatment and after 3 months follow up in all groups. • There was a significant sonographic reduction in calcification size in all groups. • At the end of the study, the best improvement as regards a decrease of calcification size was obtained in group III when compared with group I and group II.

Key message Both FSW and RSW can provide improvements in reducing calcification in the rotator cuff. Combining FSW and RSW has been shown to provide even better results

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Shoulder pain (VAS) and Calcification size before, 1 week after and at 3 months follow-up

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Wu 2023 | Low Back Pain | RSW & FSW

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Wu Z, Zhou T, Ai S. Extracorporeal shock wave therapy for low back pain: A systematic review and meta-analysis. Medicine (Baltimore). 2023 Dec 29;102(52):e36596.

Systematicreview & Meta-analysis 22 RCTs involving 1749 patients • 13 studies used RSW, 9 used FSW Results After treatment, patients in the ESWT group had

• signif. lower scores in the visual analog scale (VAS), Oswestry disability index (ODI) and Beck depression inventory • signif. shorter finger-floor distance • signif. higher Japanese orthopedic association (JOA) scores At the 3-month follow-up, The VAS and ODI remained lower.

Key message ESWT significantly improves pain & function in LBP compared to control treatments

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All diamonds are at left side of zero- line, meaningsignificantly favouring the shockwave group

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Walewicz 2020 | Low Back Pain| RSW

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Walewicz K, Taradaj J, Dobrzyński M, Sopel M, Kowal M, Ptaszkowski K, Dymarek R. Effect of Radial Extracorporeal Shock Wave Therapy on Pain Intensity, Functional Efficiency, and Postural Control Parameters in Patients with Chronic Low Back Pain: A Randomized Clinical Trial. J Clin Med. 2020 Feb 19;9(2):568.

Randomised placebo-controlled trial 40 patients with discopathy of the L5 – S1 spine segment (MRI diagnosed) with chronic pain lasting more than 3 months • Group A: PT incl core stability ex + RSW, 10 sessions (2x/wk, 2000 pulses, 2.5 bars, 5 Hz, D-Actor D20 transmitter) • Group B: PT incl core stability ex + sham RSW, 10 sessions (2x/wk) Outcomes: Pain (Laitinen scale), Function, ROM, postural sway Results: • Both groups showed improvement of outcomes. • The improvements were more pronounced in the RSW group • In the RSW group the improvements increased over time with signif difference to the placebo group at long term follow-up

Key message rESWT added to conventional PT and core stability exercises provides significant improvement of pain, ROM, function and postural sway, especially at long term (3m) follow-up compared to placebo treatment.

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PAIN

FUNCTION RQM* (Disability)

Signif. Difference between groups

RSW

Placebo

* Roland Morris Questionnaire

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Liu 2022 | Lat. Epicondylitis | Review

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Liu WC, Chen CT, Lu CC, Tsai YC, Liu YC, Hsu CW, Shih CL, Chen PC, Fu YC. Extracorporeal Shock Wave Therapy Shows Superiority Over Injections for Pain Relief and Grip Strength Recovery in Lateral Epicondylitis: A Systematic Review and Network Meta-analysis. Arthroscopy. 2022 Jun;38(6):2018-2034.e12.

Systematic review and Meta-analysis 40 RCTs were included evaluating ESWT and five different injection therapies • 10 trials of ESWT, 17 trials of corticosteroids (CS), 6 trials of botulinum toxin A (BoNTA), 10 trials of platelet-rich plasma (PRP), 4 trials of dextrose prolotherapy (DPT). Results: • DPT, ESWT , PRP, and BoNT-A were all significantly more efficacious than placebo for short-term pain relief ; • ESWT was significantly more efficacious than placebo for medium- term pain relief, while PRP was significantly less efficacious. • Among all treatment modalities, DPT was ranked as the most optimal short-term and medium-term pain reliever (SUCRA, 87.3% and 98.6%, respectively). • ESWT was ranked as the most optimal short-term and medium- term grip strength recovery (SUCRA; 79.4% and 86.4%, respectively). • Considering DASH scores and PRTEE scores as a tool for evaluating functional recovery, DPT (resp SUCRA = 73.8% and 86.5%) ranked the best among treatment options.

Key message DPT and ESWT were the best two treatment options for pain control and ESWT was the best treatment option for grip strength recovery.

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When the diamond doesn’t cross the vertical zero-line, this means the difference compared to control is statistically significant (yellow highlighted treatments in these figures).

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Nambi 2022 | Lat. Epicondylitis | RSW

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Nambi G, Alghadier M, Ebrahim EE, Verma A, Aldhafian OR, Mohamed SHP, Alshewaier SA, Sirajudeen MS, Muthusamy H, Unnikrishnan R. MRI and Ultrasound Analysis of Corticosteroid Injection Combined with Extracorporeal Shockwave Therapy in Lateral Epicondylitis-A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial. J Pers Med. 2022 Nov 11;12(11):1892.

Prospective, Randomized, Double-Blinded, Placebo- Controlled Trial 60 subjects - 1 corticosteroid injection + regular PT + 4 weekly sessions of active RSW (2000 pulses, 2.5 bar, 8 Hz) - 1 corticosteroid injection + regular PT + 4 weekly sessions of sham RSW RSW treatment applied to LE area and trigger points in m. ext. carpi rad. brevis. Outcomes: • Pain on VAS scale (primary outcome) • Injury size and grade on MRI and ultrasound; function, hand grip strength, QoL Assessments at baseline, 4wk, 8wk, 6m Results: • Both groups improved significantly on all outcomes • Improvements were signif. greater in active RSW group.

Key message ESWT has significant additional effects on corticosteroid injection for improving pain, percentage of injury on ultrasound and MRI, and functional disability.

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Pain

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Xie 2022 | CTS | Review

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Xie Y, Zhang C, Liang B, Wang J, Wang L, Wan T, Xu F, Lei L. Effects of shock wave therapy in patients with carpal tunnel syndrome: a systematic review and meta-analysis. Disabil Rehabil. 2022 Jan;44(2):177-188.

Systematicreview & Meta-analysis 10 RCTs (433 patients / 501 wrists) Results • Overall, shockwave had significant effect on pain relief, symptom severity and functional status. • Subgroup analysis showed RSW was more effective than FSW: significant differences with RSW versus insignificant differences with FSW.

Key message Shock wave, especially RSW therapy is effective for improving pain and function in CTS.

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Saglam 2022 | CTS| RSW

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Sağlam G, Çetinkaya Alişar D, Özen S. Physical therapy versus radial extracorporeal shock wave therapy in the treatment of carpal tunnel syndrome: A randomized-controlled study. Turk J Phys Med Rehabil. 2022 Mar 1;68(1):126-135.

Prospective Randomised Controlled Trial 125 wrists of 95 patients were included. 3 groups 1.Night splint + home exercise 2.Night splint + home exercise + RSW (4 bar, 5Hz, 2000 pulses) 3.Night splint + home exercise + conventional PT Results • Signif. improvement of pain, CTS symptoms and sensory nerve conduction velocity in all groups • Group 2 and 3 were signif. better than group 1 • Group 2 was signif. better than group 3

Key message: RSW treatment yields superior treatment effects compared to conventional PT

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Rashad 2020 | CTS | RSW

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Case-control study. 60 patients with unilateral carpal tunnel syndrome were divided into 3 equal groups according to severity: mild, moderate, and severe. All patients received shock wave therapy with Chattanooga Intelect RPW - 1 session per week, for 6 weeks (2000 shock/session, 1.6 bar, 0.03J/mm²) Subjects were assessed before and at the end of the treatment. Results: • Sensory conduction parameters, CSA, lateral pinch power, and pain VAS were significantly improved (P < 0.05) after shock wave therapy in all groups. • Motor latency, motor, and sensory amplitudes were significantly improved after shock wave therapy in mild and moderate groups only (P < 0.05).

Key message 6 weekly RSW sessions provided significant improvement of pain in all severity groups and of median nerve neurophysiological parameters in mild and moderate groups.

Journal link

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Vongvachvasin 2024 | CTS | FSW

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Vongvachvasin P, Phakdepiboon T, Chira-Adisai W, Siriratna P. Efficacy of focused shockwave therapy in patients with moderate-to-severe carpal tunnel syndrome: a preliminary study. J Rehabil Med. 2024 Feb 8;56:jrm13411.

Single-blind randomized controlled trial. 24 patients with moderate-to-severe carpal tunnel syndrome were randomly allocated into 2 groups: • Focused ESWT (0.01-0.15 mJ/mm², 4-5Hz, 1500 shocks, 3 weekly sessions) + conservative treatment (gliding exercises for carpal tunnel syndrome, a night wrist splint, and lifestyle modification) • Conservative treatment only Results: • Outcomes regarding symptoms & function (Thai version of Boston CT questionnaire), distal sensory & motor latency (nerve conduction tests) were significantly more improved in the FSW group than the control group.

Key message Focused ESWT added to conservative treatment demonstrated significant benefits with respect to short- term symptomatic relief, improved function, and improved nerve conduction in patients with moderate- to-severe CTS

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Symptom severity signif. Less in fESWT group at 3 and 6 weeks after baseline

Functional impairment signif. Lessin fESWTgroup at 3 and 6 weeks after baseline

Distal sensory and motor latency significantly lower in fESWT group at 3 weeks after baseline

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Wheeler 2022 | Gr. Trochanteric Pain | RSW

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Wheeler PC, Dudson C, Calver R, Goodall D, Gregory KM, Singh H, Boyd KT. Three Sessions of Radial Extracorporeal Shockwave Therapy Gives No Additional Benefit Over "Minimal-Dose" Radial Extracorporeal Shockwave Therapy for Patients With Chronic Greater Trochanteric Pain Syndrome: A Double-Blinded, Randomized, Controlled Trial. Clin J Sport Med. 2022 Jan 1;32(1):e7-e18.

Double-blinded randomised controlled trial. 120 subjects who had no improvement with 3m standard rehab. Subjects were randomised to 2 groups who received RSW treatment with Chattanooga Intelect RPW • Group 1. 3 sessions 2000 shocks 2.3-3.3 bar (max tolerable) • Group 2. 3 sessions 500 shocks 1.4 bar Results Both groups showed significant improvements in hip pain and function scores with no significant difference between the groups.

Key message 500 pulses @ 1.4 bar ("minimal dose") RSW treatment provided significant improvement of pain and PROM in GTPS. More shocks and higher pressure did not provide additional benefit.

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Wheeler 2022 | Gr. Trochanteric Pain | RSW

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Wheeler PC. Even Patients with Very Chronic Symptoms of Greater Trochanteric Pain Syndrome (GTPS) may Report Improvements Following Radial Extracorporeal Shockwave Therapy (rESWT), but no Single Baseline Factor Predicts Response. Muscles, Ligaments and Tendons Journal. 2022;12(3):411-421.

Retrospective study (level 4) 260 patients with long symptom duration (mean 44.5 months) 3 sessions RSW with Chattanooga Intelect RPW 20 Hz, 2000 pulses, 2.3-3.4 bar (max tolerable) + home exercises. Results: “Average” pain improved about 30% at 3 -months, and 37% at 6-months following rESWT. “Worst pain” improved by 25% at 3 -months, and 30% at 6- months. These improvements reached statistical significance and exceeded the minimally important clinical difference (MCID) in a patient cohort with very long average duration of symptoms. However, there was no single baseline factor that correlated with positive outcome and could have predictive value.

Key message There were clinical and statistically-significant improvements seen following rESWT for patients with GTPS, even in those with very long duration of symptoms

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Shi 2024| Fem. Head Osteonecrosis | FSW

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Shi L, Yang X, Wang P, Ma X, Li D, Wu X, Gao F, Sun W. Quantitative Magnetic Resonance Imaging of Femoral Head Articular Cartilage Change in Patients with Hip Osteonecrosis Treated with Extracorporeal Shock Wave Therapy. Int J Clin Pract. 2022 Jun 13;2022:8609868.

Prospective randomised controlled trial. 143 eligible patients with unilateral early-stage ONFH were randomised to: • ESWT group (n=73): received 2 sessions of ESWT (> 0.44mJ/mm² at 4-6 target sites on the fem. head) with oral drug treatment • Control group (n=70): received oral drug treatment only Results • At 3 and 6 months follow-up, pain and function were significantly more improved in the ESWT group than the control group. • At 12 months, T2 mapping on MRI showed a significant delay in cartilage degeneration in the ESWT group compared to the control group.

Key message ESWT added to drug treatment for ONFH provides improvement of pain and function and may delay the degeneration of the femoral head cartilage.

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P<0.05

Signif. difference (p<0.05) between groups at 3m and 6m after treatment

P<0.05

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Leng 2021 | Spasticity | RSW

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Leng Y, Lo WLA, Hu C, Bian R, Xu Z, Shan X, Huang D, Li L. The Effects of Extracorporeal Shock Wave Therapy on Spastic Muscle of the Wrist Joint in Stroke Survivors: Evidence From Neuromechanical Analysis. Front Neurosci. 2021 Jan 21;14:580762.

Single-blinded randomized controlled study. 27 stroke patients (> 1 month after onset) • RSW group (n=14): standard rehab + 1 RSW session with Chattanooga Intelect RPW • Control group (n=13): standard rehab only Outcome measure for severity of muscle spasm: MAS (Modified Ashworth Scale) Results • Significant improvement of MAS immediately post RSW and at 1 week follow-up, compared to baseline and compared to control. • Significant improvement of muscle stiffness measured by Myotonometer immediately post RSW and at 1 week follow- up, compared to baseline and compared to control. • Significant improvement of function (Fugl Meyer) at 1 week in both groups.

Key message RSW significantly reduced muscle spasm and stiffness of the wrist flexors compared to regular rehabilitation.

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Ou-Yang 2023 | Spasticity | Review

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Ou-Yang LJ, Chen PH, Lee CH, Li TY, Wu YT, Jhou HJ, Yu TY. Effect and Optimal Timing of Extracorporeal Shock-Wave Intervention to Patients With Spasticity After Stroke: A Systematic Review and Meta-analysis. Am J Phys Med Rehabil. 2023 Jan 1;102(1):43-51.

Systematic review & Meta-analysis 13 studies (677 patients) were included in the meta- analysis Spasticity and functional assessment was done at short (< 2 wks) mid (2-4 wks) and long (4-12 wks) term Spasticity (MAS) significantly improved with ESWT compared to placebo at all time points. Function significantly improved compared to placebo in the short term. Meta-regression analysisshowed that starting the ESWT at less than 45 months post stroke produced greatest benefit; if stroke is > 45 months, there was no difference anymore with placebo.

Key message Shockwave therapy is an effective treatment for post stroke spasticity with effects maintained up to 3 months.

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Favours shockwave

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Liu 2022 | Knee OA | RSW

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Liu Y, Wu C, Chen C, Zhang L, Xing G, Wu K, Zhao Z, Yin H, Ma Y. Impact of soft tissue around the knee on the efficacy of extracorporeal shockwave therapy in knee osteoarthritis. Medicine (Baltimore). 2022 Dec 16;101(50):e32334.

Retrospective clinical study Methods:

- In order to explore the relationship between the distribution of tissue around the knee joint and the clinical efficacy of ESWT in the treatment of KOA, 123 patients were grouped according to their body mass index (BMI). Proportions of soft tissue around the knee were measured with X-ray. - Subjects received Chattanooga Intelect RPW treatment 1x per week for 8 weeks. - The correlation between the distribution of tissue, pain, and functional improvement was analysed. Results - All the patients showed a significant reduction in pain after treatment compared to that before treatment (P < .01). - VAS (pain), Lequesne (disability) and WOMAC (function) indexes of the ‘overweight and above BMI’ group improved to a greater extent than that of the ‘normal or below normal’ BMI group (P < .01) after the intervention.

Key message: RSW treatment significantly improved symptoms, and the more abundant the soft tissue around the knee joint, the greater the degree to which RSW relieved knee pain and improved function.

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Tang 2024 | Knee OA | Review

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Tang P, Wen T, Lu W, Jin H, Pan L, Li H, Zeng B, Zhou Y, Xiao W, Li Y. The efficacy of extracorporeal shock wave therapy for knee osteoarthritis : an umbrella review. Int J Surg. 2024 Apr 1;110(4):2389-2395.

Umbrella review includinga total of 8 meta-analyses An umbrella review evaluates and compiles data from various meta- analyses, it represents the pinnacle of evidence-based medicine. In this study, the experimental group was treated with ESWT and the control group was treated with sham (placebo). Results • Compared to the sham group, the ESWT group showed significantly better results in • WOMAC (based on 2 meta-analyses with total of 1802 patients) • Pain VAS (based on 4 meta-analyses with total of 2313 patients) • ROM (based on 2 meta-analyses including 21 studies) • Lequesne index (based on 2 meta-analyses including 15 studies) • Six of the 8 studies were graded moderate to high quality.

Key message Based on the results of this analysis, ESWT is proven to be an effective therapy for improving pain and function in patients with KOA.

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Silva 2023 | Knee OA | Review

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Silva AC, Almeida VS, Veras PM, Carnaúba F, Filho JE, Garcia M, Fonseca DS. Effect of extracorporeal shock wave therapy on pain and function in patients with knee osteoarthritis: a systematic review with meta-analysis and grade recommendations. Clin Rehabil. 2023 Jun;37(6):760-773.

Systematic review with meta-analysis. 12 randomised clinical trials (734 subjects) were included

• 9 studies used RSW, 1 used FSW, 2 didn’t specify

• 5 compared to sham, 7 compared ESWT + PT to PT only

Results: Compared to sham treatment - ESWT was both statistically and clinically signif. more effective for pain improvement in short, mid and long term. - ESWT was both statistically and clinically signif. more effective for function improvement in short term. ESWT added to PT treatment versus PT only - Addition of ESWT was statistically more effective for pain improvement at all time points and for function improvement in short term; although the pain improvement may not be clinically significant. The quality of available studies is low

Key message ESWT compared to sham or added to PT is effective for pain and function improvement, although the quality of the available evidence is low.

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VAS Pain – ESWT vs. sham

VAS Pain – ESWT + PT versus PT only

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Ko 2022 | Knee OA | RSW/FSW

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Ko NY, Chang CN, Cheng CH, Yu HK, Hu GC. Comparative Effectiveness of Focused Extracorporeal versus Radial Extracorporeal Shockwave Therapy for Knee Osteoarthritis-Randomized Controlled Study. Int J Environ Res Public Health. 2022 Jul 24;19(15):9001.

Randomised controlled trial • 42 patients with bilateral knee osteoarthritis (KL II-III; symptom duration at least 6 months) were randomly assigned to receive 3 sessions of either f-ESWT or r-ESWT at 1-week intervals. • During each session, 2000 pulses (1000 shocks in the medial tibial plateau and 1000 shocks in the patellofemoral border) were delivered at 5 Hz. • The intensities that were used during f-ESWT (0.10 mJ/mm2) and r-ESWT (3.0 Bar) were comparable (when converting air pressure generated by ESWT to energy flux density). Results • All outcomes improved significantly in both groups at 4 and 8 weeks. • The improvements in VAS, WOMAC and 6-min walk test were significantly greater in the FSW versus the RSW group at 4 and 8 weeks, while there were no significant differences between groups for ROM. • No adverse events were reported during the study.

Key message Both FSW and RSW provide significant improvements in pain and function for KOA with FSW providing superior results.

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Significant improvement at 4 and 8 wks follow-up

Significant difference between FSW and RSW (in favour of FSW)

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Zhang 2023 | ACL Reconstruction | RSW

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Zhang S, Wen A, Li S, Yao W, Liu C, Lin Z, Jin Z, Chen J, Hua Y, Chen S, Li Y. Radial Extracorporeal Shock Wave Therapy Enhances Graft Maturation at 2-Year Follow-up After ACL Reconstruction: A Randomized Controlled Trial. Orthop J Sports Med. 2023 Feb 2;10(9):23259671221116340.

Prospective Randomized Controlled Trial. Level 1. 30 patients were randomly assigned to: • Control group: 5-week advanced rehabilitation training program (30 minutes/session, 5 times/week) starting at 3 months postoperatively. • ESWT group: advanced rehabilitation training plus radial ESWT was applied 1x/week for 5 weeks (2000 impulses, 6-8 Hz, 0.05-0.11 mJ/mm2) Result: At 24 months follow-up, functional scores (Lysholm/Tegner) were significantly better in the RSW group and graft maturation was signif. enhanced compared to the control group.

Key message 5 weekly RSW sessions applied 3 months post ACLR promotes enhanced graft maturation and improved function.

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Clinical scores

Graft maturation (signal-to-noise quotients of the ACL graft – lower SNQ means better maturation)

* Signif diff between groups (p<0.05)

# Signif diff within group compared withother time points (p<0.05)

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Weninger 2023 | ACLR | FSW

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Weninger P, Thallinger C, Chytilek M, Hanel Y, Steffel C, Karimi R, Feichtinger X. Extracorporeal Shockwave Therapy Improves Outcome after Primary Anterior Cruciate Ligament Reconstruction with Hamstring Tendons. J Clin Med. 2023 May 9;12(10):3350.

Randomised controlled study 65 patients were randomized into two groups

• Group A: ESWT group - received focused shockwave therapy (1500 shocks, 0.25mJ/cm², 5Hz) 4, 5 and 6 weeks after ACL surgery in addition to 'early active rehabilitation. • Group B: control group - received 'early active rehabilitation' only Results • Return to activity and sports was significantly earlier in ESWT group. • At 12m, 83.8% of patients in the ESWT group vs. 21.4% in control group attained the “pre - injury activity level” • Clinical scores for pain and function were significantly more improved in the ESWT group • Graft maturation on MRI was significantly better in the ESWT group

Key message: Focused shockwave treatment produced significantly better return to sports parameters, as well as significantly better clinical outcome scores and graft maturation.

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Clinical scores

P<0.001

Graft maturation at 12m after ACLR

Signif. diff between groups at all time points

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Gomez Garcia 2017 | MTSS | FSW

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Gomez Garcia S, Ramon Rona S, Gomez Tinoco MC, Benet Rodriguez M, Chaustre Ruiz DM, Cardenas Letrado FP, Lopez-Illescas Ruiz Á, Alarcon Garcia JM. Shockwave treatment for medial tibial stress syndrome in military cadets: A single-blind randomized controlled trial. Int J Surg. 2017 Oct;46:102-109.

Single-blind randomised controlled study. 42 militarycadets with chronic MTSS were randomly assigned to • one session of focused electromagnetic ESWT (1500 pulses at 0.20 mJ/mm2) plus a specific exercise programme, or • the exercise programme alone. Results ESWT patients were able to run longer. Mean running test duration after 4 weeks was 17 min 33 s compared to 4 min 48 s in the exercise-only group (p = 0.000). Mean VAS after running was 2.17 in the ESWT group versus 4.26 in the exercise-only group (p = 0.001). The ESWT group had a significantly higher RM score, with excellent or good results for 82.6% of patients vs. 36.8% in the exercise-only group (p = 0.002). No significant adverse effects of ESWT were observed

Key message A single application of FSW treatment in combination with a specific exercise programme produced a success rate of 82.6% at 4 weeks, and produced significantly better results than exercise only.

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