Management of partial-thickness rotator cuff tears with autologous adipose-derived regenerative cells is safe and more effective than injection of corticosteroid.

Symptomatic, partial-thickness rotator cuff tears (sPTRCT) are problematic. This study tested the hypothesis that management of sPTRCT with injection of fresh, uncultured, unmodified, autologous, adipose-derived regenerative cells (UA-ADRCs) is safe and more effective than injection of corticosteroid even in the long run. To this end, subjects who had completed a former randomized controlled trial were enrolled in the present study. At baseline these subjects had not responded to physical therapy treatments for at least 6 weeks, and were randomly assigned to receive respectively a single injection of UA-ADRCs (n = 11) or a single injection of methylprednisolone (n = 5). Efficacy was assessed using the ASES Total score, pain visual analogue scale (VAS), RAND Short Form-36 Health Survey and range of motion at 33.2 ± 1.0 (mean ± SD) and 40.6 ± 1.9 months post-treatment. Proton density, fat-saturated, T2-weighted MRI of the index shoulder was performed at both study visits. There were no greater risks connected with injection of UA-ADRCs than those connected with injection of corticosteroid. The subjects in the UA-ADRCs group showed statistically significantly higher mean ASES Total scores than the subjects in the corticosteroid group. The MRI scans at 6 months post-treatment allowed to "watch the UA-ADRCs at work".

Methodological Flaws in Meta-Analyses of Clinical Studies on the Management of Knee Osteoarthritis with Stem Cells: A Systematic Review.

(1) Background: Conclusions of meta-analyses of clinical studies may substantially influence opinions of prospective patients and stakeholders in healthcare. Nineteen meta-analyses of clinical studies on the management of primary knee osteoarthritis (pkOA) with stem cells, published between January 2020 and July 2021, came to inconsistent conclusions regarding the efficacy of this treatment modality. It is possible that a separate meta-analysis based on an independent, systematic assessment of clinical studies on the management of pkOA with stem cells may reach a different conclusion. (2) Methods: PubMed, Web of Science, and the Cochrane Library were systematically searched for clinical studies and meta-analyses of clinical studies on the management of pkOA with stem cells. All clinical studies and meta-analyses identified were evaluated in detail, as were all sub-analyses included in the meta-analyses. (3) Results: The inconsistent conclusions regarding the efficacy of treating pkOA with stem cells in the 19 assessed meta-analyses were most probably based on substantial differences in literature search strategies among different authors, misconceptions about meta-analyses themselves, and misconceptions about the comparability of different types of stem cells with regard to their safety and regenerative potential. An independent, systematic review of the literature yielded a total of 183 studies, of which 33 were randomized clinical trials, including a total of 6860 patients with pkOA. However, it was not possible to perform a scientifically sound meta-analysis. (4) Conclusions: Clinicians should interpret the results of the 19 assessed meta-analyses of clinical studies on the management of pkOA with stem cells with caution and should be cautious of the conclusions drawn therein. Clinicians and researchers should strive to participate in FDA and/or EMA reviewed and approved clinical trials to provide clinically and statistically valid efficacy.

Why and how to use the body's own stem cells for regeneration in musculoskeletal disorders: a primer.

BACKGROUND: Recently, the management of musculoskeletal disorders with the patients' own stem cells, isolated from the walls of small blood vessels, which can be found in great numbers in the adipose tissue, has received considerable attention. On the other hand, there are still misconceptions about these adipose-derived regenerative cells (ADRCs) that contain vascular-associated pluripotent stem cells (vaPS cells) in regenerative medicine. METHODS: Based on our previous publications on this topic, we have developed a concept to describe the significance of the ADRCs/vaPS cells in the field of orthobiologics as briefly as possible and at the same time as precisely as possible. RESULTS: The ADRCs/vaPS cells belong to the group of orthobiologics that are based on autologous cells. Because the latter can both stimulate a patient's body's localized self-healing power and provide new cells that can integrate into the host tissue during the healing response when the localized self-healing power is exhausted, this group of orthobiologics appears more advantageous than cell-free orthobiologics and orthobiologics that are based on allogeneic cells. Within the group of orthobiologics that are based on autologous cells, enzymatically isolated, uncultured ADRCs/vaPS cells have several advantages over non-enzymatically isolated cells/microfragmented fat as well as over uncultured bone marrow aspirate concentrate and cultured cells (adipose-derived stem cells, bone marrow-derived mesenchymal stem cells). CONCLUSIONS: The use of ADRCs/vaPS cells can be seamlessly integrated into modern orthopedic treatment concepts, which can be understood as the optimization of a process which-albeit less efficiently-also takes place physiologically. Accordingly, this new safe and effective type of treatment is attractive in terms of holistic thinking and personalized medicine.

The Composition of Adipose-Derived Regenerative Cells Isolated from Lipoaspirate Using a Point of Care System Does Not Depend on the Subject's Individual Age, Sex, Body Mass Index and Ethnicity.

Uncultured, unmodified, autologous, adipose-derived regenerative cells (UA-ADRCs) are a safe and effective treatment option for various musculoskeletal pathologies. However, it is unknown whether the composition of the final cell suspension systematically varies with the subject's individual age, sex, body mass index and ethnicity. UA-ADRCs were isolated from lipoaspirate from n = 232 subjects undergoing elective lipoplasty using the Transpose RT system (InGeneron, Inc.; Houston, TX, USA). The UA-ADRCs were assessed for the number of nucleated cells, cell viability and the number of viable nucleated cells per gram of adipose tissue harvested. Cells from n = 37 subjects were further characterized using four-channel flow cytometry. The present study shows, for the first time, that key characteristics of UA-ADRCs can be independent of the subject's age, sex, BMI and ethnicity. This result has important implications for the general applicability of UA-ADRCs in regeneration of musculoskeletal tissue. Future studies must determine whether the independence of key characteristics of UA-ADRCs of the subject's individual age, sex, BMI and ethnicity only applies to the system used in the present study, or also to others of the more than 25 different experimental methods and commercially available systems used to isolate UA-ADRCs from lipoaspirate that have been described in the literature.

Exposure of zebra mussels to radial extracorporeal shock waves: implications for treatment of fracture nonunions.

BACKGROUND: Radial extracorporeal shock wave therapy (rESWT) is an attractive, non-invasive therapy option to manage fracture nonunions of superficial bones, with a reported success rate of approximately 75%. Using zebra mussels (Dreissena polymorpha), we recently demonstrated that induction of biomineralization after exposure to focused extracorporeal shock waves (fESWs) is not restricted to the region of direct energy transfer into calcified tissue. This study tested the hypothesis that radial extracorporeal shock waves (rESWs) also induce biomineralization in regions not directly exposed to the shock wave energy in zebra mussels. METHODS: Zebra mussels were exposed on the left valve to 1000 rESWs at different air pressure (between 0 and 4 bar), followed by incubation in calcein solution for 24 h. Biomineralization was evaluated by investigating the fluorescence signal intensity found on sections of the left and right valves prepared two weeks after exposure. RESULTS: General linear model analysis demonstrated statistically significant (p < 0.05) effects of the applied shock wave energy as well as of the side (left/exposed vs. right/unexposed) and the investigated region of the valve (at the position of exposure vs. positions at a distance to the exposure) on the mean fluorescence signal intensity values, as well as statistically significant combined energy × region and energy × side × region effects. The highest mean fluorescence signal intensity value was found next to the umbo, i.e., not at the position of direct exposure to rESWs. CONCLUSIONS: As in the application of fESWs, induction of biomineralization by exposure to rESWs may not be restricted to the region of direct energy transfer into calcified tissue. Furthermore, the results of this study may contribute to better understand why the application of higher energy flux densities beyond a certain threshold does not necessarily lead to higher success rates when treating fracture nonunions with extracorporeal shock wave therapy.

Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study.

BACKGROUND: This study tested the hypothesis that treatment of symptomatic, partial-thickness rotator cuff tears (sPTRCT) with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated from lipoaspirate at the point of care is safe and more effective than corticosteroid injection. METHODS: Subjects aged between 30 and 75 years with sPTRCT who did not respond to physical therapy treatments for at least 6 weeks were randomly assigned to receive a single injection of an average 11.4 × 106 UA-ADRCs (in 5 mL liquid; mean cell viability: 88%) (n = 11; modified intention-to-treat (mITT) population) or a single injection of 80 mg of methylprednisolone (40 mg/mL; 2 mL) plus 3 mL of 0.25% bupivacaine (n = 5; mITT population), respectively. Safety and efficacy were assessed using the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), RAND Short Form-36 Health Survey, and pain visual analogue scale (VAS) at baseline (BL) as well as 3 weeks (W3), W6, W9, W12, W24, W32, W40, and W52 post treatment. Fat-saturated T2-weighted magnetic resonance imaging of the shoulder was performed at BL as well as at W24 and W52 post treatment. RESULTS: No severe adverse events related to the injection of UA-ADRCs were observed in the 12 months post treatment. The risks connected with treatment of sPTRCT with UA-ADRCs were not greater than those connected with treatment of sPTRCT with corticosteroid injection. However, one subject in the corticosteroid group developed a full rotator cuff tear during the course of this pilot study. Despite the small number of subjects in this pilot study, those in the UA-ADRCs group showed statistically significantly higher mean ASES total scores at W24 and W52 post treatment than those in the corticosteroid group (p < 0.05). DISCUSSION: This pilot study suggests that the use of UA-ADRCs in subjects with sPTRCT is safe and leads to improved shoulder function without adverse effects. To verify the results of this initial safety and feasibility pilot study in a larger patient population, a randomized controlled trial on 246 patients suffering from sPTRCT is currently ongoing. TRIAL REGISTRATION: Clinicaltrials.gov ID NCT02918136. Registered September 28, 2016, https://clinicaltrials.gov/ct2/show/NCT02918136. LEVEL OF EVIDENCE: Level I; prospective, randomized, controlled trial.

Exposure of zebra mussels to extracorporeal shock waves demonstrates formation of new mineralized tissue inside and outside the focus zone.

The success rate of extracorporeal shock wave therapy (ESWT) for fracture nonunions in human medicine (i.e. radiographic union at 6 months after ESWT) is only approximately 75%. Detailed knowledge regarding the underlying mechanisms that induce bio-calcification after ESWT is limited. We analyzed the biological response within mineralized tissue of a new invertebrate model organism, the zebra mussel Dreissena polymorpha, after exposure with extracorporeal shock waves (ESWs). Mussels were exposed to ESWs with positive energy density of 0.4 mJ/mm2 (A) or were sham exposed (B). Detection of newly calcified tissue was performed by exposing the mussels to fluorescent markers. Two weeks later, the A-mussels showed a higher mean fluorescence signal intensity within the shell zone than the B-mussels (P<0.05). Acoustic measurements revealed that the increased mean fluorescence signal intensity within the shell of the A-mussels was independent of the size and position of the focal point of the ESWs. These data demonstrate that induction of bio-calcification after ESWT may not be restricted to the region of direct energy transfer of ESWs into calcified tissue. The results of the present study are of relevance for better understanding of the molecular and cellular mechanisms that induce formation of new mineralized tissue after ESWT.

Radial extracorporeal shock wave therapy is efficient and safe in the treatment of fracture nonunions of superficial bones: a retrospective case series.

BACKGROUND: A substantial body of evidence supports the use of focused extracorporeal shock wave therapy (fESWT) in the non-invasive treatment of fracture nonunions. On the other hand, virtually no studies exist on the use of radial extracorporeal shock wave therapy (rESWT) for this indication. METHODS: We retrospectively analyzed 22 patients treated with rESWT for fracture nonunions of superficial bones that failed to heal despite initial surgical fixation in most cases. Radial extracorporeal shock wave therapy was applied without anesthesia in three rESWT sessions on average, with one rESWT session per week and 3000 radial extracorporeal shock waves at an energy flux density of 0.18 mJ/mm2 per session. Treatment success was monitored with radiographs and clinical examinations. RESULTS: Six months after rESWT radiographic union was confirmed in 16 out of 22 patients (73%), which is similar to the success rate achieved in comparable studies using fESWT. There were no side effects. The tibia was the most common treatment site (10/22) and 70% of tibia nonunions healed within 6 months after rESWT. Overall, successfully treated patients showed a mean time interval of 8.8 ± 0.8 (mean ± standard error of the mean) months between initial fracture and commencement of rESWT whereas in unsuccessfully treated patients the mean interval was 26.0 ± 10.1 months (p < 0.05). In unsuccessful tibia cases, the mean interval was 43.3 ± 13.9 months. CONCLUSIONS: Radial extracorporeal shock wave therapy appears to be an effective and safe alternative in the management of fracture nonunions of superficial bones if diagnosed early and no fESWT device is available. The promising preliminary results of the present case series should encourage the implementation of randomized controlled trials for the early use of rESWT in fracture nonunions.

Long-term results of radial extracorporeal shock wave treatment for chronic plantar fasciopathy: A prospective, randomized, placebo-controlled trial with two years follow-up.

Numerous randomized controlled trials (RCTs) demonstrated efficacy and safety of extracorporeal shock wave therapy (ESWT) for chronic plantar fasciopathy (cPF). However, only two such RCTs investigated a follow-up period of more than 1 year, both applying focused ESWT. Corresponding data for radial ESWT (rESWT) have not yet been reported. We therefore tested the hypothesis that rESWT is effective and safe for the management of cPF with long-term follow-up of 2 years. To this end n = 50 patients with cPF were randomly allocated to either two sessions of rESWT (one session per week; 2,000 shock waves with energy flux density of 0.16 mJ/mm2 per session) (n = 25) or to placebo treatment (n = 25). Evaluation was by change in Visual Analog Scale (VAS) score and Roles and Maudsley (RM) score. Mean pretreatment VAS scores for the rESWT and placebo groups were 8.5 and 8.9, respectively. 1, 3, 6, 12, and 24 months after treatment, the mean VAS scores for the rESWT and placebo groups were 0.6, 1.1, 0.5, 2.3, and 1.4 and 7.6, 7.7, 7.4, 6.9, and 5.6 (p < 0.001), respectively. Differences in mean RM scores were statistically significant between groups at 1, 3, 6, 12, and 24 months post treatment, but not at baseline. There were no significant complications. These data indicate that rESWT is effective and safe for the management of cPF with long-term follow-up of 2 years. © 2016 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 35:1532-1538, 2017.

Radial Extracorporeal Shock Wave Therapy Is Effective and Safe in Chronic Distal Biceps Tendinopathy.

OBJECTIVE: To assess the efficacy and safety of radial extracorporeal shock wave therapy (rESWT) for chronic distal biceps tendinopathy (cDBT). DESIGN: Case-control study (level of evidence, 3). SETTING: SUN Orthopaedics and Sports Medicine. PATIENTS: Patients with a diagnosis of cDBT were recruited between January 2010 and February 2015. INTERVENTIONS: Patients received a single session of rESWT (2000 shock waves with energy flux density of 0.18 mJ/mm) or other forms of nonoperative therapy. MAIN OUTCOME MEASURES: Patients completed the visual analog scale (VAS), the modified QuickDASH (MQD) score, and the Roles and Maudsley (RM) score over a 12-month period. RESULTS: Forty-eight patients completed the final review at 12 months and were included in the study. Subjects ranged in age from 30 to 64 years. Mean pretreatment VAS scores for the rESWT and control groups were 8.3 and 8.5, respectively. Three and 12 months after inclusion in the study, the mean VAS scores for the rESWT and control groups were 3.4 and 5.6 (P < 0.001) and 2.7 and 4.7 (P < 0.001), respectively. Twelve-month follow-up MQD-Sports and MQD-Work scores for the rESWT and control groups were 3.7 and 1.7 (P < 0.001) and 3.8 and 1.8 (P < 0.001), respectively. Differences in mean RM scores were statistically significant between groups at 3 months after the treatment. There were no significant complications. CONCLUSIONS: Overall, rESWT is an effective and safe treatment for cDBT. CLINICAL RELEVANCE: Radial ESWT as a novel, effective, and safe treatment for cDBT.

Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: a systematic review on studies listed in the PEDro database.

BACKGROUND: Extracorporeal shock wave therapy (ESWT) is an effective and safe non-invasive treatment option for tendon and other pathologies of the musculoskeletal system. SOURCES OF DATA: This systematic review used data derived from the Physiotherapy Evidence Database (PEDro; www.pedro.org.au, 23 October 2015, date last accessed). AREAS OF AGREEMENT: ESWT is effective and safe. An optimum treatment protocol for ESWT appears to be three treatment sessions at 1-week intervals, with 2000 impulses per session and the highest energy flux density the patient can tolerate. AREAS OF CONTROVERSY: The distinction between radial ESWT as 'low-energy ESWT' and focused ESWT as 'high-energy ESWT' is not correct and should be abandoned. GROWING POINTS: There is no scientific evidence in favour of either radial ESWT or focused ESWT with respect to treatment outcome. AREAS TIMELY FOR DEVELOPING RESEARCH: Future randomized controlled trials should primarily address systematic tests of the aforementioned optimum treatment protocol and direct comparisons between radial and focused ESWT.

Radial Shock Wave Devices Generate Cavitation.

BACKGROUND: Conflicting reports in the literature have raised the question whether radial extracorporeal shock wave therapy (rESWT) devices and vibrating massage devices have similar energy signatures and, hence, cause similar bioeffects in treated tissues. METHODS AND FINDINGS: We used laser fiber optic probe hydrophone (FOPH) measurements, high-speed imaging and x-ray film analysis to compare fundamental elements of the energy signatures of two rESWT devices (Swiss DolorClast; Electro Medical Systems, Nyon, Switzerland; D-Actor 200; Storz Medical, Tägerwillen, Switzerland) and a vibrating massage device (Vibracare; G5/General Physiotherapy, Inc., Earth City, MO, USA). To assert potential bioeffects of these treatment modalities we investigated the influence of rESWT and vibrating massage devices on locomotion ability of Caenorhabditis elegans (C. elegans) worms. RESULTS: FOPH measurements demonstrated that both rESWT devices generated acoustic waves with comparable pressure and energy flux density. Furthermore, both rESWT devices generated cavitation as evidenced by high-speed imaging and caused mechanical damage on the surface of x-ray film. The vibrating massage device did not show any of these characteristics. Moreover, locomotion ability of C. elegans was statistically significantly impaired after exposure to radial extracorporeal shock waves but was unaffected after exposure of worms to the vibrating massage device. CONCLUSIONS: The results of the present study indicate that both energy signature and bioeffects of rESWT devices are fundamentally different from those of vibrating massage devices. CLINICAL RELEVANCE: Prior ESWT studies have shown that tissues treated with sufficient quantities of acoustic sound waves undergo cavitation build-up, mechanotransduction, and ultimately, a biological alteration that "kick-starts" the healing response. Due to their different treatment indications and contra-indications rESWT devices cannot be equated to vibrating massage devices and should be used with due caution in clinical practice.

Treatment of chronic plantar fasciopathy with extracorporeal shock waves (review).

There is an increasing interest by doctors and patients in extracorporeal shock wave therapy (ESWT) for chronic plantar fasciopathy (PF), particularly in second generation radial extracorporeal shock wave therapy (RSWT). The present review aims at serving this interest by providing a comprehensive overview on physical and medical definitions of shock waves and a detailed assessment of the quality and significance of the randomized clinical trials published on ESWT and RSWT as it is used to treat chronic PF. Both ESWT and RSWT are safe, effective, and technically easy treatments for chronic PF. The main advantages of RSWT over ESWT are the lack of need for any anesthesia during the treatment and the demonstrated long-term treatment success (demonstrated at both 6 and 12 months after the first treatment using RSWT, compared to follow-up intervals of no more than 12 weeks after the first treatment using ESWT). In recent years, a greater understanding of the clinical outcomes in ESWT and RSWT for chronic PF has arisen in relationship not only in the design of studies, but also in procedure, energy level, and shock wave propagation. Either procedure should be considered for patients 18 years of age or older with chronic PF prior to surgical intervention.

Systematic review of contracture reduction in the lower extremity with dynamic splinting.

INTRODUCTION: Joint contractures are relatively common disorders that can result in significant, long-term morbidity. Initial treatment is non-operative and often entails the use of mechanical modalities such as dynamic and static splints. Although widely utilized, there is a paucity of data that support the use of such measures. The purpose of this systematic review was to evaluate the safety and efficacy of dynamic splinting as it is used to treat joint contracture in lower extremities, and to determine if duration on total hours of stretching had an effect on outcomes. METHODS: Reviews of PubMed, Science Direct, Medline, AMED, and EMBASE websites were conducted to identify the term 'contracture reduction' in manuscripts published from January 2002 to January 2012. Publications selected for inclusion were controlled trials, cohort studies, or case series studies employing prolonged, passive stretching for lower extremity contracture reduction. A total of 354 abstracts were screened and eight studies (487 subjects) met the inclusion criteria. The primary outcome measure was change in active range of motion (AROM). RESULTS: The mean aggregate change in AROM was 23.5º in the eight studies examined. Dynamic splinting with prolonged, passive stretching as home therapy treatment showed a significant direct, linear correlation between the total number of hours in stretching and restored AROM. No adverse events were reported. DISCUSSION: Dynamic splinting is a safe and efficacious treatment for lower extremity joint contractures. Joint specific stretching protocols accomplished greater durations of end-range stretching which may be considered to be responsible for connective tissue elongation.

A single application of low-energy radial extracorporeal shock wave therapy is effective for the management of chronic patellar tendinopathy.

PURPOSE: Extracorporeal shock wave therapy (SWT) is effective for the management of chronic recalcitrant tendinopathy. The objective of the current study was to assess whether a standardized, single treatment SWT is effective for the management of chronic patellar tendinopathy METHODS: Thirty-three patients with chronic patellar tendinopathy received low-energy SWT. Thirty-three patients with chronic patellar tendinopathy received other forms of non-operative therapy (control group). Evaluation was by change in Visual Analogue Scale (VAS), Victoria Institute of Sport Assessment score for patellar tendinopathy (VISA-P) score and by Roles and Maudsley Score. RESULTS: Mean pre-treatment VAS scores for the control and SWT groups were 7.5 and 7.8, respectively. One month, 3 months, and 12 months after treatment, the mean VAS for the control and SWT groups were 6.7 and 4.3 (p < 0.001), 5.9 and 3.5 (p < 0.001), and 5.1 and 2.7 (p < 0.001), respectively. One month, 3 months, and 12 months after treatment, the mean VISA for the control and SWT groups were 50.7 and 65.5 (p < 0.001), 52.1 and 71 (p < 0.001), and 54.9 and 74.5 (p < 0.001), respectively. At final follow-up, the number of excellent, good, fair, and poor results for the SWT and control groups were 8 and 3 (p < 0.001), 17 and 10 (p < 0.001), 5 and 16 (p < 0.001), and 3 and 4 (p < 0.001), respectively. The percentage of patients with excellent ("1") or good ("2") Roles and Maudsley Scores (i.e. successful results) 12 months after treatment was statistically greater in the SWT group compared to the control group (p < 0.001). CONCLUSION: A single application of radial SWT is an effective treatment for chronic patellar tendinopathy. LEVEL OF EVIDENCE: III.

Effects of extracorporeal shock wave therapy on fracture nonunions.

The purpose of this study was to examine the effect of focused extracorporeal shock wave therapy (ESWT) on the treatment of nonunions. As part of a prospective study, we included 143 patients (average age, 41.4 years) with a diagnosis of nonunion (mean, 14.1 months; range, 6-84 months). High-energy shock wave treatment was applied using shock wave generator. The shock waves were applied in 3-5 sessions of 2500 to 3000 impulses each given at 0.25-0.84 mJ/mm(2), at intervals of 48-72 hours between sessions. A maximum of 3 cycles of treatment was given, at 3-month intervals. The patients were followed during a 12-month period until fracture healing or, in case of failure, until another therapy was adopted. Complete healing was observed in 80 of 143 cases (55.9%) at an average time of 7.6 months (range 2-24 months). Partial healing occurred in 41 cases (28.7%) and no healing was observed in 22 cases (15.4%). Patients with trophic nonunions had a better success rate than patients with atrophic nonunions (P<.05). The results show extracorporeal shock wave therapy is a safe and effective treatment for nonunion. ESWT is more effective for trophic nonunions than atrophic nonunions.

Shockwave therapy for the treatment of chronic proximal hamstring tendinopathy in professional athletes.

BACKGROUND: Chronic proximal hamstring tendinopathy is an overuse syndrome that is usually managed by nonoperative methods. Shockwave therapy has proved to be effective in many tendinopathies. HYPOTHESIS: Shockwave therapy may be more effective than other nonoperative treatments for chronic proximal hamstring tendinopathy. STUDY DESIGN: Randomized controlled clinical study; Level of evidence, 1. METHODS: Forty professional athletes with chronic proximal hamstring tendinopathy were enrolled between February 1, 2004, and September 30, 2006. Patients were randomly assigned to receive either shockwave therapy, consisting of 2500 impulses per session at a 0.18 mJ/mm² energy flux density without anesthesia, for 4 weeks (SWT group, n = 20), or traditional conservative treatment consisting of nonsteroidal anti-inflammatory drugs, physiotherapy, and an exercise program for hamstring muscles (TCT group, n = 20). Patients were evaluated before treatment, and 1 week and 3, 6, and 12 months after the end of treatment. The visual analog scale (VAS) score for pain and Nirschl phase rating scale (NPRS) were used as primary outcome measures. RESULTS: The patients were observed for a mean of 10.7 months (range, 1-12 months). Six patients were lost to follow-up because they underwent a surgical intervention: 3 (all in TCT group) were lost at 3 months; 2 (1 in each group), at 6 months; and 1 (in the TCT group), at 12 months. Primary follow-up was at 3 months after the beginning of treatment. The VAS scores in the SWT and TCT groups were 7 points before treatment (P = .84), and 2 points and 5 points, respectively, 3 months after treatment (P < .001). The NPRS scores in the SWT and TCT groups were 5 points in either group before treatment (P = .48), and 2 points and 6 points, respectively, 3 months after treatment (P < .001). At 3 months after treatment, 17 of the 20 patients (85%) in the SWT group and 2 of the 20 patients (10%) in the TCT group achieved a reduction of at least 50% in pain (P < .001). There were no serious complications in the SWT group. CONCLUSION: Shockwave therapy is a safe and effective treatment for patients with chronic proximal hamstring tendinopathy.

Plantar fascia-specific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy.

BACKGROUND: Whether plantar fascia-specific stretching or shock-wave therapy is effective as an initial treatment for proximal plantar fasciopathy remains unclear. The aim of this study was to test the null hypothesis of no difference in the effectiveness of these two forms of treatment for patients who had unilateral plantar fasciopathy for a maximum duration of six weeks and which had not been treated previously. METHODS: One hundred and two patients with acute plantar fasciopathy were randomly assigned to perform an eight-week plantar fascia-specific stretching program (Group I, n = 54) or to receive repetitive low-energy radial shock-wave therapy without local anesthesia, administered weekly for three weeks (Group II, n = 48). All patients completed the seven-item pain subscale of the validated Foot Function Index and a patient-relevant outcome questionnaire. Patients were evaluated at baseline and at two, four, and fifteen months after baseline. The primary outcome measures were a mean change in the Foot Function Index sum score at two months after baseline, a mean change in item 2 (pain during the first few steps of walking in the morning) on this index, and satisfaction with treatment. RESULTS: No difference in mean age, sex, weight, or duration of symptoms was found between the groups at baseline. At two months after baseline, the Foot Function Index sum score showed significantly greater changes for the patients managed with plantar fascia-specific stretching than for those managed with shock-wave therapy (p < 0.001), as well as individually for item 2 (p = 0.002). Thirty-five patients (65%) in Group I versus fourteen patients (29%) in Group II were satisfied with the treatment (p < 0.001). These findings persisted at four months. At fifteen months after baseline, no significant between-group difference was measured. CONCLUSIONS: A program of manual stretching exercises specific to the plantar fascia is superior to repetitive low-energy radial shock-wave therapy for the treatment of acute symptoms of proximal plantar fasciopathy.

Shock wave therapy as a treatment of nonunions, avascular necrosis, and delayed healing of stress fractures.

Shock wave therapy (SWT) stimulates angiogenesis and osteogenesis. SWT is commonly used to treat soft tissue musculoskeletal conditions such as fasciopathies and tendinopathies. Recent basic science and clinical data suggest that SWT can also be used to treat disorders of bone. Nonunions, avascular necrosis, and delayed healing of stress fractures have all been successfully treated with SWT. Success rates with SWT are equal to those with standard surgical treatment, but SWT has the advantage of decreased morbidity. The procedure is safe, well tolerated, yields few complications, and, typically, can be performed on an outpatient basis. SWT is a viable noninvasive alternative to stimulate healing of bone.

Shock wave therapy compared with intramedullary screw fixation for nonunion of proximal fifth metatarsal metaphyseal-diaphyseal fractures.

BACKGROUND: The current "gold standard" for treatment of chronic fracture nonunion in the metaphyseal-diaphyseal region of the fifth metatarsal is intramedullary screw fixation. Complications with this procedure, however, are not uncommon. Shock wave therapy can be an effective treatment for fracture nonunions. The purpose of this study was to evaluate the safety and efficacy of shock wave therapy as a treatment of these nonunions. METHODS: Twenty-three patients with a fracture nonunion in the metaphyseal-diaphyseal region of the fifth metatarsal received high-energy shock wave therapy (2000 to 4000 shocks; energy flux density per pulse, 0.35 mJ/mm(2)), and twenty other patients with the same type of fracture nonunion were treated with intramedullary screw fixation. The numbers of fractures that were healed at three and six months after treatment in each group were determined, and treatment complications were recorded. RESULTS: Twenty of the twenty-three nonunions in the shock wave group and eighteen of the twenty nonunions in the screw fixation group were healed at three months after treatment. One of the three nonunions that had not healed by three months in the shock wave group was healed by six months. There was one complication in the shock wave group (post-treatment petechiae) and eleven complications in the screw-fixation group (one refracture, one case of cellulitis, and nine cases of symptomatic hardware). CONCLUSIONS: Both intramedullary screw fixation and shock wave therapy are effective treatments for fracture nonunion in the metaphyseal-diaphyseal region of the fifth metatarsal. Screw fixation is more often associated with complications that frequently result in additional surgery.