Abuse of Dominance: The Third Wave of Brazil’s Antitrust Enforcement? Ana Paula Martinez* T he first Brazilian competition law dates from 1962, but it was only in the mid-1990s when the modern era of antitrust began as the country shifted to a market-based economy. Among other reforms, in 1994 Congress enacted Law No 8,884, which governed Brazil’s administrative antitrust law
Advantag of ingestion administration way is its easiness even when applied at home. But with their help necessary treatment concentration in blood cannot be always quickly achieve buy antibiotics online transaction is carried out on anonymity and mutual profit principles, and in addition customers will be positively surprised with quality and speed of service.
Chroniccure.ie0363-5465/103/3131-0268$02.00/0THE AMERICAN JOURNAL OF SPORTS MEDICINE, Vol. 31, No. 2 2003 American Orthopaedic Society for Sports Medicine Shock Wave Application for Chronic
Plantar Fasciitis in Running Athletes
A Prospective, Randomized, Placebo-Controlled Trial
Jan D. Rompe,* MD, Jens Decking, MD, Carsten Schoellner, MD, and Bernhard Nafe, MD From the Department of Orthopaedics, Johannes Gutenberg University School of Medicine, Background: Recent articles have reported success with repeated low-energy shock wave application for treatment of chronic
plantar fasciitis in runners.
Hypothesis: Shock wave treatment for chronic plantar fasciitis is safe and effective.
Study Design: Prospective, randomized, placebo-controlled trial.
Methods: Forty-five running athletes with intractable plantar heel pain for more than 12 months were enrolled; half were
assigned to a treatment group that received three applications of 2100 impulses of low-energy shock waves, and half received
sham treatment. Follow-up examinations were performed at 6 months and at 1 year by a blinded observer.
Results: After 6 months, self-assessment of pain on first walking in the morning was significantly reduced from an average of
6.9 to 2.1 points on a visual analog scale in the treatment group and from an average of 7.0 to 4.7 points in the sham group.
The mean difference between groups was 2.6 points. After 12 months, there was a further reduction of pain in both groups, to
an average 1.5 points in the treatment group, and to 4.4 points in the sham group.
Conclusion: Three treatments with 2100 impulses of low-energy shock waves were a safe and effective method for treatment
of chronic plantar fasciitis in long-distance runners.
2003 American Orthopaedic Society for Sports Medicine
Chronic plantar fasciitis due to cumulative overload stress protocol is regarded as the mainstay of recommended treat- is one of the most common painful foot conditions observed ment.32 The use of shoes with shock-absorbing soles or shoes in runners, both competitive athletes and those who run fitted with a standard orthopaedic device such as a rubber for basic conditioning.12,22,45 The specific pathologic fea- heel pad or taping of the foot into a specific position is also tures of this clinical entity are not well understood; inflam- recommended. The recommendation of heel elevation to mation of the plantar fascia, thickening of the proximal achieve reduction of loading of the plantar fascia is contro- fascia, decreased vascularity, peritendinous inflammation, versial.19 Steroid injections into the painful area also have loss of normal elasticity, and alteration of nociceptor physi- been used27 but are associated with a significant risk of ology all may play roles in the onset and persistence of heel subsequent rupture of the plantar fascia.23 pain.22,30 The pain is usually present when the patient first Usually, plantar fasciitis can be treated successfully by stands on his or her feet after awakening, and it persists or tailoring treatment to a patient’s risk factors and prefer- becomes worse with activities of daily living. The use of ences. When nonoperative treatment options are unsuc- nonoperative methods such as rest, application of ice to the cessful, physicians often resort to open or endoscopic re- sore area, nonsteroidal antiinflammatory medication, or top-ical application of steroids will alleviate the condition in most lease of a portion of the plantar fascial insertion onto the patients,14,33,37,39,42 and the performance of a stretching calcaneus. If there is suspicion of entrapment of the cal-caneal branches of the tibial nerve, the nerves can bedecompressed. As with any surgery, fascial release is notwithout substantial risk and may be associated with pro- * Address correspondence and reprint requests to Jan D. Rompe, MD, longed healing time and postoperative rehabilitation; an Department of Orthopaedics, Johannes Gutenberg University School of Med- alteration of foot biomechanical integrity may also icine, Langenbeckstrasse 1, D-55131 Mainz, Germany.
One author has received financial benefit from research in this study.
Shock Wave Application for Plantar Fasciitis Because of the recognized risks and delayed healing week before symptoms occurred. Over a period of more associated with surgery, alternative nonoperative thera- than 6 months, at least three attempts of nonoperative peutic methods have been assessed. Since 1996, there treatment had failed to provide pain relief for all patients: have been reports of promising results from the use of this included at least two prior courses of intervention extracorporeal shock wave application for plantar fasci- with physical therapy, the use of orthotic devices, and at itis, particularly in Europe.7,9,20,26,30,31,34 Randomized, least one prior course of pharmacologic treatment.
controlled studies on shock wave application and prospec- Exclusion Criteria. Exclusion criteria included dysfunc- tive observational trials on shock wave application have tion in the knee or ankle, local arthritis, generalized poly- reported comparable treatment effects in 50% to 60% of arthritis, rheumatoid arthritis, ankylosing spondylitis, patients.2,10 The scientific value of some of the studies Reiter’s syndrome, neurologic abnormalities, nerve en- that examined the use of shock wave application for treat- trapment syndrome, a history of previous plantar fascial ment of plantar fasciitis was seriously questioned recent- surgery, age of less than 18 years, pregnancy, infections or ly.6 Therefore, the current clinical study was planned as a tumors, a history of spontaneous or steroid-induced rup- prospective, randomized, single-blinded evaluation of the ture of the plantar fascia, bilateral heel pain, participation potential for low-energy electromagnetic application of ex- in a workers’ compensation program, or use of systemic tracorporeal shock waves to bring about pain relief for therapeutic anticoagulants or nonsteroidal antiinflamma- chronic plantar fasciitis in runners. Our hypothesis was tory drugs for any chronic condition. No other treatment that three applications of 2100 impulses were superior to was permitted until 6 weeks after shock wave application, three placebo applications at 6 months after treatment.
with the exception of use of already-worn shoe insertsduring the period of treatment. Patients were instructedto use the foot but to avoid painful stress.
Forty-nine patients qualified for the study, of whom 4 The study was designed as a randomized, single-center, declined to be randomized, leaving 45 patients enrolled in single-blinded parallel treatment study with an indepen- the study (Fig. 1). Extracorporeal shock wave treatment dent observer to determine the effectiveness of three ap- was free of cost to all participants. No crossover between plications of 2100 impulses of low-energy shock waves to the two groups was offered. In case of failure of treatment, the heels of long-distance runners with intractable plan- the patients were invited to undergo surgery of the heel.
tar fasciitis. A sham treatment group was used for All patients had been treated unsuccessfully by their gen- eral practitioner, and 38 patients had also been treated byan orthopaedic practitioner. All patients had been givenmedication, mostly nonsteroidal antiinflammatory drugs, and had received shock-absorbing shoe inserts. All had On the basis of the results of a pilot study,36 a difference performed some kind of stretching exercises on a regular of 3 points on the average pain rating on a visual analog basis; only 18 patients had used night splints. Eleven scale ranging from 0 to 10 points was assumed to be asignificant difference between the groups, with a commonstandard deviation of 3 points. A sample size of 17 pa-tients per treatment group would have more than 80% ofthe power to detect the treatment difference with a two-sided significance level of 0.05. Accordingly, a sample sizeof 22 patients per treatment group, including an assumed20% rate of patients lost to follow-up, was calculated togive sufficient statistical power. The sample size was alsosufficient for the evaluation of the treatment differencesin terms of the Ankle-Hindfoot Scale,18 and in terms of thesubjective four-step rating scale.
Over a period of 3 years, recreational athletes who ranmore than 30 miles per week and were suffering fromchronic plantar fasciitis for more than 12 months werescreened and randomized to one of two treatment groups:active treatment or sham treatment.
Inclusion Criteria. For the current study, chronic heel pain was defined as symptoms of moderate-to-severe heelpain in the involved foot at the origin of the proximalplantar fascia on the medial calcaneal tuberosity. Thepain must have persisted for at least 12 months before thestudy enrollment, in patients who ran at least 30 miles per Figure 1. Profile of the randomized controlled trial.
American Journal of Sports Medicine patients had been immobilized in a cast for at least 2 another. Each study subject assigned to active treatment weeks, and an average of 2.8 corticosteroid injections had underwent shock wave application for a total of 6300 been given (range, 1 to 5). An average of three different shocks in three treatment sessions, with a 1-week interval physical therapy treatment regimens had been used, such in between, at an energy flux density of 0.16 mJ/mm2 and as icing, ultrasound, magnetic field, iontophoresis or pho- at a frequency of 4 Hz, without local anesthesia. Ultra- nophoresis, contrast baths, or radiation therapy (range, sound coupling gel was used between the treatment head one to five different treatment regimens).
and the heel. The shock tube head was applied underin-line ultrasound control (Fig. 2); fine adjustment to the most tender region was performed by palpation and inter-action with the patient. Treatment was started at the After 4 weeks of no treatment at all and after giving lowest energy level, 1, for 50 impulses and was then in- informed consent, the patients were reevaluated regard- creased to energy level 2 for another 50 impulses. Then ing exclusion criteria and were then randomized into the 2000 impulses of energy level 3 (energy flux density of 0.16 two treatment groups by use of identical sealed envelopes.
Patients in the two groups did not differ regarding weekly For those patients assigned to sham treatment, a sound- running distance, age, sex, duration of pain, weight, or reflecting pad was interposed between the coupling mem- body mass index. The first shock wave application started brane of the treatment head and the heel to absorb the immediately after the identification of treatment group.
shock waves through the presence of multiple air cavities.
Shock Wave Treatment Group. The treatment group No coupling gel was used. A total of 6300 shocks was consisted of 10 women and 12 men, with a mean age of 43 delivered in three treatment sessions, with a 1-week in- years (range, 32 to 59) and a mean duration of pain of 20 terval in between, effectively duplicating the duration and Sham Treatment Group. The group receiving sham treatment consisted of 13 women and 10 men, with amean age of 40 years (range, 30 to 61) and a mean dura- tion of pain of 18 months (range, 12 to 72).
All patients were assessed before and after treatment. Theactual study procedure was conducted by a physician who was aware of the treatment. However, this physicianplayed no role in assessing the patients after treatment.
The extracorporeal shock wave therapy was applied by a Another physician, an independent treatment-blinded ob- mobile therapy unit especially designed for orthopaedic server, examined the patients at 6 and at 12 months after use (Sonocur Plus, Siemens AG, Erlangen, Germany), the last application of the extracorporeal shock wave with the shock wave head suspended by an articulating arm for flexible movement of the head in three planes. Theshock wave head was equipped with an electromagneticshock wave emitter. Shock wave focus guidance was es- tablished by in-line integration of an ultrasound probe (a7.5-MHz sector scanner) in the shock head. The physical The primary outcome measure was prospectively defined output parameters of the device, measured with a laser as reduction of the subject’s self-assessment of pain on first walking in the morning. On the visual analog scale, Both groups were treated under the same conditions, 10 points indicated unbearable pain and 0 points, no pain and patients were treated singly to avoid influencing one at all. The 6-month interval was selected because it was Output Parameters of the Shock Wave Device Shock Wave Application for Plantar Fasciitis to walk free from pain for more than 1 hour. Three pointswas considered acceptable, with symptoms somewhat im-proved, pain at a more tolerable level than before treat-ment, and the patient slightly satisfied with the treatmentoutcome. Four points indicated a poor outcome, withsymptoms identical or worse and the patient dissatisfiedwith the treatment outcome.
The methods used for statistical analysis in this studywere determined by the local Institute for Medical Statis-tics and Documentation before the study was begun andwere performed by them when the study was completed.
Wilcoxon’s rank sum test was applied for comparison ofthe difference between the two groups for pseudocontinu-ous, not normally distributed variables, such as pain whenfirst walking in the morning and scores on the Ankle-Hindfoot Scale.24 The four-step scale, a categorical vari-able, was compared by means of Fisher’s exact test and itsextension to 2 ϫ N contingency tables. The level of signif-icance was set at 95%. Tested comparisons with P valuesof less than 0.05 were considered to be significantly dif-ferent. Multiple adjustments were not performed for sec-ondary outcome measures, which were measured in anexploratory way. The primary outcome measure wastested in a confirmatory way.28 Twenty-two and 23 patients were randomized consecu- Figure 2. Ultrasound-guided adaptation of the shock wave
tively to each group. Two patients in the treatment group head to the medioplantar aspect of the left heel.
and one patient in the sham group were lost to follow-up.
Thus, after 6 months, 19 patients in the treatment groupand 20 in the sham group were evaluated (Fig. 1). One expected that the healing process would likely be evident patient in the treatment group and two patients in the (although not necessarily complete) at this point in time.
sham group refused further contact because of lack ofsuccess of the therapy.
At 12 months, the intervention had been ineffective for two patients, who refused to cooperate further, and one Prospectively defined secondary outcome measures for patient could not be contacted. Thus, 16 patients in the clinical evaluation 6 and 12 months after treatment in- treatment group were available for examination. Nineteen cluded at least a 50% reduction of a subject’s self-assess- patients in the sham group were evaluated at 12 months, ment of pain on first walking in the morning, a visual and one additional patient refused to cooperate further analog scale rating of less than 4 of 10 points, and im- because shock wave therapy had not improved his provement from the baseline in the American Orthopaedic Foot and Ankle Society’s Ankle-Hindfoot Scale.18 Thisstrictly clinical score has 100 possible points (pain, 40 points; function, 50 points; alignment, 10 points). In addi-tion, patients had to show improvement from baseline on The primary outcome measure was prospectively defined a subjective four-point rating scale and achievement of a as reduction of pain on first walking in the morning after rating less than or equal to two points at 6 months and at 6 months of a subject’s self-assessment. Results are pre- 12 months after shock wave application. On the scale, 1 sented in Table 2. The mean difference between groups point was defined as excellent, with the patient having no was 2.6 points (P ϭ 0.0004; 95% confidence interval, 1.3 to pain, satisfied with the treatment outcome, and able to perform unlimited walking free from pain. Two points was After 6 months, 12 of 20 patients (60%) in the treatment defined as good, with symptoms significantly improved group and 6 of 22 patients (27%) in the sham group re- and the patient satisfied with treatment outcome and able ported more than a 50% improvement in pain on first American Journal of Sports Medicine during the various and unsuccessful treatment regimens Mean Reduction in Self-Assessment of Pain on First Walking in before the current study. No patient discontinued the shock wave procedure because of severe pain. No side effects were seen at either follow-up examination. Therewere no hematomas, infections, or abnormal neurologic walking in the morning, with values of less than 4 points Numbers of concurrent interventions did not differ signif- on the visual analog scale (P ϭ 0.0600). These results icantly between groups at follow-up. At 6 months, 3 of 19 included those of one patient in the treatment group and patients (16%) in the treatment group and 6 of 20 patients two patients in the sham group who reported via tele- (30%) in the sham group received further nonoperative phone an ineffectiveness of the intervention and refused therapy. At 12 months, 3 of 16 patients (19%) in the further clinical evaluation; they were rated as treatment treatment group and 5 of 19 patients (26%) in the sham failures. After 12 months, 13 of 18 patients (72%) in the group received further nonoperative therapy. One patient treatment group and 7 of 20 patients (35%) in the sham in each group had undergone surgery (6% and 5%, group reported more than a 50% improvement in pain on first walking in the morning (P ϭ 0.0051). These resultsalso included those of two patients in the treatment groupand one patient in the sham group who reported by tele- phone an ineffectiveness of the intervention and refused The clinical diagnosis of plantar fasciitis is relatively easy further clinical evaluation; they were also rated as treat- to make.21 Radiographically, a heel spur on the inferior surface of the calcaneus frequently is evident but is not After 6 months, an increase in the Ankle-Hindfoot Scale considered pathognomonic of the disorder.37 Magnetic res- was observed in both groups, by 37.2 Ϯ 15.2 points in the onance imaging regularly shows edematous involvement treatment group and by 19.4 Ϯ 17.8 points in the sham of the calcaneal insertion of the plantar aponeurosis, with group (P ϭ 0.0025). The three patients who refused to a marked thickening of the proximal segment of the cen- participate further in the study because of ineffectiveness tral cord of the plantar fascia.4,13,29,40 Although proximal of treatment were not included in the computation of the plantar fasciitis is the most frequent cause of inferomedial score. Results are given in Table 3.
heel pain, other pathologic conditions, such as seronega- Before the extracorporeal shock wave therapy started, tive arthropathies or nerve entrapment, may be causal in all patients rated their condition as “4” in the subjective about 10% of cases. Two patient cohorts seem to have a four-step scale. There was no difference between the particularly high incidence of plantar fasciitis: obese mid- groups at this point in time. After 6 months, an improve- dle-aged women and young male runners.26,30,37 ment was seen in both groups on the four-step scale, by Most authors agree that subjects with insertional plan- 1.9 Ϯ 0.9 points in the treatment group and by 1.0 Ϯ 1.0 tar fasciitis have a self-limiting disease and that most will point in the sham group (P ϭ 0.0112). Results are given in attain good results without significant intervention.
Therefore, the initial treatment should be nonoperative,with use of modalities such as physical therapy, especially fascial stretching, orthoses, night splints, shoe wear mod-ifications, and nonsteroidal antiinflammatory drugs.30 Low-energy extracorporeal shock wave therapy was con- However, Martin et al.27 reviewed numerous studies of sidered unpleasant by all patients, although not as un- nonsurgical treatment for plantar fasciitis and showed a pleasant as the local infiltration all patients had had wide variation of acceptable outcomes, ranging from 44%to 82% of patients obtaining complete relief of heel pain.
In their metaanalysis, Crawford et al.12 looked for ran- Mean Scores on the American Orthopaedic Foot and Ankle domized controlled trials on plantar fasciitis and found 11 studies on nonoperative treatment since 1966. However, these trials had low methodologic assessment scores; not a single one evaluated the effectiveness of surgical therapy.
The metaanalysis showed there was limited evidence for the short-term effectiveness of topical corticosteroid ad-ministered by iontophoresis and for the effectiveness of use of dorsiflexion night splints. A preliminary study from our institution also showed limited evidence of the effective- ness of low-energy extracorporeal shock wave therapy.34 This preliminary positive outcome has been confirmed in prospective clinical studies from various university hospi- tals.20,31,38 The scientific value of these studies was seri- Shock Wave Application for Plantar Fasciitis ously questioned recently,6 and the therapeutic mechanism months, pressure pain had dropped for patients in group 1 involved remains a topic of speculation.15,25 Ogden et al.30 from 77 points to 19 points on a visual analog scale. In postulated that shock waves are directed at controlled mi- group 2, the ratings did not decrease significantly, from 79 crodisruption of internal fascial tissue, which initiates a points to 77 points. In group 1, walking became completely more appropriate healing response within the fascia and a free from pain for 25 of 50 patients, compared with none of better long-term capacity to adapt to biologic and biome- 48 patients in group 2. By 5 years, when the rates of good chanical demands. No evidence was presented.
or excellent outcomes in the four-step score were com- There is no consensus so far concerning the (repeated) pared, the difference of only 11% in favor of group 1 was no use of low-energy shock waves, requiring no local anesthe- longer significant; pressure pain was down to 9 points in sia,34,36 versus the (single) use of high-energy shock group 1 and to 29 points in group 2. Meanwhile, 5 of 38 waves, requiring local or regional anesthesia.7,30 Indeed, patients (13%) in group 1 had undergone surgery of the there is no consensus so far as to how to differentiate heel, compared with 23 of 40 patients (58%) in group 2.
low-energy from high-energy shock waves, because multi- Buchbinder et al.8 included 166 patients in a double- ple physical parameters are involved (see Table 1). Al- blind, randomized, placebo-controlled trial. Patients were though the clinical effect of both protocols appears to be randomly assigned to receive either ultrasound-guided comparable, as discussed later, there is clear evidence of extracorporeal shock wave treatment given weekly for 3 increasing side effects with the application of increasing weeks to a total dose of at least 1 J/mm2 or an identical energy levels.35 With the treatment regimen described in placebo to a total dose of 0.006 J/mm2. After significant this article, deleterious side effects are extremely unlikely improvements in both groups (26.3 points in the treat- as compared with treatment regimens involving applica- ment group, 25.7 points in the sham group), there was no tion of higher-energy flux densities. No local anesthesia evidence for superiority of extracorporeal shock wave was required, so related side effects are lacking. The only treatment over placebo. The study by Buchbinder et al. is “disadvantage” is that, according to our experience, a re- of excellent quality, but there are some points to be dis- cussed. First, patients in the treatment group did not Maier et al.26 recently reported good or excellent results receive identical treatment (either 2000 or 2500 shock on a subjective four-step score in 75% of 48 heels 29 waves per treatment of energy levels varying between months after low-energy shock waves were applied three 0.02 mJ/mm2 and 0.33 mJ/mm2), in contrast with the times at weekly intervals without local anesthesia. The current study. Second, the mean dose in the treatment clinical outcome was not influenced by the length of fol- group was 1407 mJ/mm2, 500 mJ/mm2 more than in the low-up. No negative side effects were reported. Wang et current study. In the experience of the authors of the al.43 reported 33 of 41 patients to be either free of pain or current study, patients will not tolerate such a high dose significantly better at 12 weeks after shock wave therapy.
unless the treatment area of maximal pain is missed.
Ogden et al.30 published results of a randomized placebo- Accordingly, and third, Buchbinder et al. did not focus on controlled study with 119 patients in the treatment group the area of maximal pain as in the current study, but on and 116 patients in the placebo group. Twelve weeks after the area of maximal thickness of the plantar fascia.
a single application of 1500 high-energy shock waves at Fourth, a potent analgesic drug was allowed for the dura- 18 kV under regional anesthesia, success was observed in tion of the study. Fifth, patients were enrolled with a pain 47% of patients (56). After sham treatment, the success history as short as 6 weeks, in contrast with the 12 rate was only 30% (35 patients). The results of this study months in the current study. Sixth, there was no real led to approval of shock wave therapy for painful heel by placebo group; sham therapy consisted of application of the United States Food and Drug Administration in 2000.
Buch et al.7 reported the results of another randomized In the current study, better results were observed 6 placebo-controlled study for the Food and Drug Adminis- months after low-energy shock wave application of 2100 tration involving 150 patients. Therapy was applied once, impulses compared with sham treatment, with a signifi- with 3800 high-energy impulses under regional anesthe- cant reduction of the subjects’ self-assessment of pain on sia. After 3 months, 61% of the patients (45 patients) in first walking in the morning by an average of 5 points in the treatment group and only 40% (29 patients) of the the treatment group (from 7 to 2 points) and by 2 points placebo group met the success criterion. Chen et al.9 stud- (from 7 to 5 points) in the sham group. Sixty percent of ied 80 patients treated with 1000 shock wave impulses at patients in the treatment group, versus 27% of the pa- 14 kV. Fifty-four patients were evaluated at 6 months.
tients in the sham group, reported at least a 50% reduc- There were no complaints from 32 patients (59.3%), and tion and a visual analog scale rating of less than 4 of 10 15 patients (27.7%) were significantly improved.
points. After 12 months, 72% of the patients of the treat- More recently, we reported a randomized controlled ment group, versus 35% of the patients of the sham group, trial of shock wave therapy in 112 patients.36 Group 1 rated accordingly. Cointerventions remained on a compa- received 3 applications of 1000 impulses of a low-energy flux density, and group 2 received 3 applications of 10 Because of the well-described natural history of proxi- impulses within 2 weeks. When the rates of good and mal plantar fasciitis,30 it was expected that symptoms of excellent outcome on a four-step score were compared chronic heel pain could resolve with time, even in this between the two groups, there was a significant difference selected treatment patient population in whom several of 47% in favor of group 1 treatment at 6 months. At 6 previous nonoperative treatments had failed. Therefore, American Journal of Sports Medicine the improvement in both groups between 6 months and 1 9. Chen HS, Chen LM, Huang TW: Treatment of painful heel syndrome with shock waves. Clin Orthop 387: 41– 46, 2001 year after treatment probably reflects the self-limiting 10. Concato J, Shah N, Horwitz RI: Randomized, controlled trials, observa- course of the disease. However, more patients in the treat- tional studies, and the hierarchy of research designs. N Engl J Med 342: ment group improved during this period of follow-up than 11. Conti RJ, Shinder M: Soft tissue calcifications induced by local corticoste- in the sham group. No side effects have been reported so roid injection. J Foot Surg 30: 34 –37, 1991 far from low-energy extracorporeal shock wave applica- 12. Crawford F, Atkins D, Edward J: Interventions for treating plantar heel pain tion, compared with calcification after steroid injections or (Cochrane Review), in Cochrane Library, Issue 3. Oxford, Update Soft-ware, 2000 postoperative development of wound infections, hypertro- 13. Grasel RP, Schweitzer ME, Kovalovich AM, et al: MR imaging of plantar phic sensitive scars, or calcaneal fractures.5,11,37 In the fasciitis: Edema, tears, and occult marrow abnormalities correlated with current study, no negative side effects were recorded. This outcome. AJR Am J Roentgenol 173: 699 –701, 1999 14. Gudeman SD, Eisele SA, Heidt RS Jr, et al: Treatment of plantar fasciitis clinical experience is in accordance with those of histologic by iontophoresis of 0.4% dexamethasone. A randomized, double-blind, and MRI-based studies.26,35 High-energy shock waves, placebo-controlled study. Am J Sports Med 25: 312–316, 1997 also in use for the treatment of heel pain,30,31,38 on the 15. Heller KD, Niethard FU: Using extracorporeal shockwave therapy in or- thopedics: A meta-analysis [in German]. Z Orthop Ihre Grenzgeb 136: other hand, may produce side effects such as periosteal detachments and small fractures of the inner surface of 16. Henricson AS, Westlin NE: Chronic calcaneal pain in athletes: Entrapment of the calcaneal nerve? Am J Sports Med 12: 152–154, 1984 17. Ikeda K, Tomita K, Takayama K: Application of extracorporeal shock wave on bone: Preliminary report. J Trauma 47: 946 –950, 1999 18. Kitaoka HB, Alexander IJ, Adelaar RS, et al: Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int 15: 349 – 19. Kogler GF, Veer FB, Verhulst SJ, et al: The effect of heel elevation on The results of the current study revealed beneficial effects strain within the plantar aponeurosis: In vitro study. Foot Ankle Int 22:433– 439, 2001 of low-energy extracorporeal shock wave therapy in long- 20. Krischek O, Rompe JD, Herbsthofer B, et al: Symptomatic low-energy distance runners with chronic plantar fasciitis. In accor- shockwave therapy in heel pain and radiologically detected plantar heel dance with the results of other prospective randomized spur. Z Orthop Ihre Grenzgeb 136: 169 –174, 1998 21. Lapidus PW, Guidotti FP: Painful heel: Report of 323 patients with 364 controlled trials,7,30,36 shock wave therapy appeared to be painful heels. Clin Orthop 39: 178 –186, 1965 a useful, noninvasive treatment method with negligible 22. Leach RE, DiIorio E, Harney RA: Pathologic hindfoot conditions in the side effects. The level of evidence for success with this athlete. Clin Orthop 177: 116 –121, 1983 23. Leach RE, Jones R, Silva T: Rupture of the plantar fascia in athletes.
treatment concept is still limited,6,12 but this is true also J Bone Joint Surg 60A: 537–539, 1978 for other nonoperative procedures and especially true for 24. Lehmann EL: Nonparametrics: Statistical Methods Based on Ranks. San surgical treatment, which bears a higher risk of compli- 25. Loew M, Daecke W, Kusnierczak D, et al: Shock-wave therapy is effective cations. Therefore, we recommend shock wave therapy to for chronic calcifying tendinitis of the shoulder. J Bone Joint Surg 81B: any patient who has had unsuccessful conventional non- 26. Maier M, Steinborn M, Schmitz C, et al: Extracorporeal shock wave operative treatment over a period of at least 6 months, application for chronic plantar fasciitis associated with heel spurs: Predic- before considering an operative intervention. Further pro- tion of outcome by magnetic resonance imaging. J Rheumatol 27: 2455– spective work is necessary to compare the effectiveness of 27. Martin RL, Irrgang JJ, Conti SF: Outcome study of subjects with inser- repeated low-energy shock wave application without local tional plantar fasciitis. Foot Ankle Int 19: 803– 811, 1998 anesthesia with the efficacy of single high-energy shock 28. Maurer W, Hothorn LA, Lehmacher W: Multiple comparison in drug wave application with local or regional anesthesia.
clinical trials and preclinic assays: A priori ordered hypotheses, inVollmer J (ed): Biometrie in der pharmazeutischen Industrie. Volume 6.
Testing Principles in Clinical and Preclinical Trials. Stuttgart, Fischer,1995, pp 3–18 29. Narvaez JA, Narvaez J, Ortega R, et al: Painful heel: MR imaging findings.
30. Ogden JA, Alvarez R, Levitt R, et al: Shock wave therapy for chronic 1. Barrett SL, Day SV: Endoscopic plantar fasciotomy for chronic plantar proximal plantar fasciitis. Clin Orthop 387: 47–59, 2001 fasciitis/heel spur syndrome: Surgical technique— early clinical results. J 31. Perlick L, Boxberg W, Giebel G: High-energy shock wave treatment of the painful heel spur [in German]. Unfallchirurg 101: 914 –918, 1998 2. Benson K, Hartz AJ: A comparison of observational studies and random- 32. Pfeffer G, Bacchetti P, Deland J, et al: Comparison of custom and pre- ized, controlled trials. N Engl J Med 342: 1878 –1886, 2000 fabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot 3. Benton-Weil W, Borelli AH, Weil LS Jr, et al: Percutaneous plantar fas- ciotomy: A minimally invasive procedure for recalcitrant plantar fasciitis. J 33. Probe RA, Baca M, Adams R, et al: Night splint treatment for plantar Foot Ankle Surg 37: 269 –272, 1998 fasciitis. A prospective randomized study. Clin Orthop 368: 190 –195, 4. Berkowitz JF, Kier R, Rudicel S: Plantar fasciitis: MR imaging. Radiology 34. Rompe JD, Hopf C, Nafe B, et al: Low-energy extracorporeal shock wave 5. Blanco CE, Leon HO, Guthrie TB: Endoscopic treatment of calcaneal spur therapy for painful heel. A prospective controlled single-blind study. Arch syndrome: A comprehensive technique. Arthroscopy 17: 517–522, 2001 Orthop Trauma Surg 115: 75–79, 1996 6. Bo¨ddeker R, Scha¨fer H, Haake M: Extracorporeal shockwave therapy 35. Rompe JD, Kirkpatrick CJ, Kullmer K, et al: Dose-related effects of shock (ESWT) in the treatment of plantar fasciitis—A biometrical review. Clin waves on rabbit tendo Achillis. A sonographic and histological study.
J Bone Joint Surg 80B: 546 –552, 1998 7. Buch M, Knorr U, Fleming L, et al: Extracorporeal shockwave therapy in 36. Rompe JD, Schoellner C, Nafe B: Evaluation of low-energy extracorporeal plantar fasciitis—-3 months results of a multicentre prospective random- shock-wave application and treatment of chronic plantar fasciitis. J Bone ised double blind placebo controlled trial. Orthopa¨de 31: 637– 644, 2002 8. Buchbinder R, Ptasznik R, Gordon J, et al: Ultrasound-guided extracor- 37. Schepsis AA, Leach RE, Gorzyca J: Plantar fasciitis. Etiology, treatment, poral shock wave therapy for plantar fasciitis: A randomized controlled surgical results, and review of the literature. Clin Orthop 266: 185–196, trial. JAMA 288: 1364 –1372, 2002 Shock Wave Application for Plantar Fasciitis 38. Sistermann R, Katthagen BD: Five-year lithotripsy of plantar heel spur: 42. Tomczak RL, Haverstock BD: A retrospective comparison of endoscopic Experiences and results. A follow-up study after 36.9 months [in German].
plantar fasciotomy to open plantar fasciotomy with heel spur resection for chronic Z Orthop Ihre Grenzgeb 136: 402– 406, 1998 plantar fasciitis/heel spur syndrome. J Foot Ankle Surg 34: 305–311, 1995 39. Sobel E, Levitz SJ, Caselli MA: Orthoses in the treatment of rearfoot 43. Wang CJ, Chen HS, Chen SW, et al: Treatment of painful heels using problems. J Am Podiatr Med Assoc 89: 220 –233, 1999 extracorporeal shock wave. J Formos Med Assoc 99: 580 –583, 2000 40. Steinborn M, Heuck A, Maier M, et al: MRI of plantar fasciitis [in 44. Wapner KL, Sharkey PF: The use of night splints for treatment of recal- German]. RoFo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 170: citrant plantar fasciitis. Foot Ankle 12: 135–137, 1991 45. Ward WG, Clippinger FW: Proximal medial longitudinal arch incision for 41. Theodorou DJ, Theodorou SJ, Kakitsubata Y, et al: Plantar fasciitis and plantar fascia release. Foot Ankle 8: 152–155, 1987 fascial rupture: MR imaging findings in 26 patients supplemented with 46. Young CC, Rutherford DS, Niedfeldt MW: Treatment of plantar fasciitis.
anatomic data in cadavers. Radiographics 20: S181–S197, 2000 Am Fam Physician 63: 467– 478, 2001
Skin Disease/Sign Medications 2000, Derm Facts Adverse Drug Reaction Probability Scale Question 1. Are there previous conclusive reports of this reaction? 2. Did the adverse event appear after the suspected drug was administered? 3. Did the adverse reaction improve when the drug was discontinued or a specific antagonist was administered? 4. Did the adverse reaction reappear w