Although robust, a Student t test, like other parametric tests, is dependent on a level of homogeneity of variance. Either problem, we believed, was sufficient to exclude this study from further consideration. Roche and West 17 and Binder et al 63 examined the effects of ultrasound, but they did not demonstrate an equivalence of the experimental and control subject groups before the study began.
In the study by Roche and West, 17 the ulcer size was markedly less in the placebo ultrasound group Binder et al 63 provided evidence of equivalence of patient details such as age but not of the initial measures of grip strength or of pain used to evaluate the effect of using ultrasound.
Consequently, any apparent differences between the groups after treatment may have been due to differences between subjects in each group. For example, more subjects in the ultrasound group may have had lesions that were likely to recover more quickly, perhaps because of their relative recency or lesser severity or because of other factors such as the age and activity level of a subject.
Initial equivalence of groups cannot be assumed; therefore, we believe the results are not compelling. Dyson 62 identified another problem in the study by Binder et al. The etiology of overuse injury suggests that rest is likely to be effective in assisting the resolution of this condition.
From the original 35 studies identified, Table 2 shows that 10 studies remained. In this section, we analyze the 10 studies that we believed to be methodologically acceptable.
The focus, however, will be on identifying common factors that might distinguish the 2 studies in which ultrasound affected the outcomes from those studies in which ultrasound did not affect the outcomes.
Table 3 shows the conditions that the subjects had and the dosages used in the 10 studies. Some details had to be estimated, specifically, the size of the applicator for articles published prior to 25 — 28 , 51 and the size of area treated. In the absence of information on the geometric size of the applicator, we assumed it to equal the ERA. This produces, in some instances, a small overestimation of the wattage applied. With the size of area treated, this was estimated from descriptions of the area treated and is clearly a potential source of error when used in subsequent calculations of energy density.
Space-averaged time-averaged intensity SATA calculated from peak output and pulse frequency. This calculation was done to enable comparisons of dosage between trials. Table 3 shows considerable variation among studies, probably compounded by the necessity for us to use estimates of applicator size and size of the area treated with ultra-sound in many calculations.
Studies in which 3-MHz frequency ultrasound was used had outputs ranging from 30 J 25 to J. If multiplied by 3 to give some measure of comparability with 1-MHz frequency energy levels that are available at a superficial depth, the dosage estimates fall within a range of 90 to 1, J in the lower range outputs used with a 1-MHz frequency.
The ultrasound dosages used in the 2 studies in which differences were found between placebo and active ultrasound 31 , 54 estimated total energy applied as 2, and J, respectively were within the range of those used in studies in which no differences were found. This finding suggests to us that there was no obvious source of differences between the 2 categories of studies in the dosages of ultrasound applied.
This is a large range. These differences in the energy density used suggest that comparable areas are not treated with similar dosages. There also was no apparent relationship between the year of the study and energy density applied. In the first study 51 and the most recent study 31 using a 1-MHz frequency, researchers applied the highest energy densities.
Table 3 shows that a similar phenomenon occurred among studies using a 3-MHz frequency. The limitation of this analysis was the uncertainty added by the use of some estimates in the calculations. We based estimates we made of the geometric size of the applicator 25 — 27 , 51 and the size of the area treated 6 , 25 — 28 , 31 , 54 on the details provided in the respective articles.
We made these estimates to compare the effect of different levels of dosage energy density on patient outcomes.
The data, however, suggest that there was considerable variation in energy density that is not accounted for by the type of patient problem, by the size or depth of the area treated, or by the year of the study.
The diversity of problems treated with ultrasound limits comparisons between studies and possible conclusions on effective dosages. Each study reviewed compared the effects of active and placebo ultrasound.
Depending on the condition treated, both groups also had either identical concurrent treatment or no additional concurrent treatment. This allowed the contribution of ultra-sound to be distinguished from other components of multiple interventions, the aim of an RCT. Between-study comparisons were difficult even for studies that seemed similar because of differences in the inclusion criteria used.
For example, Ebenlicher et al 31 used ultrasound for people with calcific tendinitis of the shoulder, whereas Nykanen 6 simply said that the subjects had shoulder pain. The possibility of a meaningful comparison is limited by one study 6 having included a wider range of shoulder problems than the other study. A variety of outcome measures also were used. At least one study 54 had a problematic outcome measure, discussed earlier, in which ordinal data were added. In that study, however, the authors also examined the results of electroneurological testing, which was used as a diagnostic tool and as an outcome measure.
Nerve conduction studies can provide an accurate assessment of conditions involving compromise of peripheral nerves, 67 , 68 including carpal tunnel syndrome. We contend, therefore, that differences in findings were not attributable to problems with outcome measures.
In all 10 of the studies, active ultrasound and placebo ultrasound were used. In 3 studies 25 , 26 , 51 there was what we would consider a true control group, which received neither active ultrasound nor placebo ultrasound. In each of these studies, the group that received active ultrasound had better outcomes than the true control group outcome measures: pain, 25 , 26 , 51 facial swelling, 25 , 26 trismus, 25 , 26 serum C-reactive proteins, 25 , 26 plasma cortisol, 26 weight test, 51 pain and power with wrist dorsiflexion, 51 and grip strength test In the 2 studies in which the group that received the placebo treatment and true control group were compared, the authors reported better outcomes for the group that received the placebo treatment than for the true control group.
We identified 2 categories of methodologically acceptable studies: studies in which ultrasound was found to produce desirable outcomes and studies in which that was not found.
The same first authors published the only 2 studies showing active ultrasound as more effective than placebo ultrasound that were, we believe, methodologically adequate. Not all methodological filters were strictly applied.
In particular, whether experimental blinding filter 2 was effectively implemented during ultrasound use was not certain in 16 of the 26 studies remaining at that stage in the screening process. This issue is relevant to both studies that showed active ultrasound had desirable outcomes. Blinding of subjects and therapists was not addressed in the earlier study by Ebenbichler and colleagues.
Had filter 2 been strictly applied, both studies would have been excluded early in the screening process. In both studies by Ebenbichler and colleagues, 31 , 54 the investigators applied ultrasound when it was possibly not the ideal treatment.
In a letter commenting on a different study investigating the use of ultrasound in people with carpal tunnel syndrome, a physiatrist contended that there were risks of aggravating the condition by heating directly over the nerve rather than over associated structures.
In the later study by Ebenbichler et al, 31 the researchers treated individuals with calcific tendinitis of the shoulder. A feature of this condition can be the spontaneous resorption of the calcium deposits over time. The study by Perron and Malouin 48 had 2 groups—a treatment group and a true control group. The authors found no differences between the 2 groups over the 3 weeks of the study. During this time, both groups had positive changes, with a decreased size and density of calcium deposits and an increased range of passive shoulder abduction with decreased pain during it.
In no instance was the change in any outcome measure statistically significantly different between the groups. That is, the natural course of calcific tendinitis was unaltered by ultrasound. In this review, we found few RCTs that investigated the contribution of therapeutic ultrasound to patient outcomes that met the minimal standards of methodological adequacy.
Of the 10 RCTs that did meet our standards, 2 studies demonstrated improvements in outcome measures in subjects treated with ultrasound. In Eben-bichler and colleagues' study of subjects with calcific tendinitis of the shoulder, the outcome measures were change in calcium deposits in the shoulder and subjective symptoms and pain. Ultrasound has been used therapeutically for over 6 decades in the ways reported in the trials examined in this study. In our review, we found that is not the case.
Furthermore, in the few methodologically adequate studies that exist, treatment was provided for a wide range of problems; thus, few conclusions can be drawn. Similarly, no replications exist of studies with significant findings. Having different researchers in a different facility using the same procedure and obtaining a similar finding would considerably affect the strength of our certainty about ultrasound.
We found that the dosages of ultrasound used in the studies we reviewed varied considerably and for reasons that were not always clear. No underlying patterns were evident except possibly that the studies with significant outcomes were among those using a higher total energy output. Furthermore, without adequate data, there is little scientific basis for dosage selection in clinical practice. This leaves a question of the extent to which the diversity of dosages used helps explain the limited evidence of effectiveness of therapeutic ultrasound.
One possible limitation of our review is its exclusive focus on RCTs. There are a number of other methods of obtaining relevant information about therapeutic ultra-sound. Unless these effects are not only consistent with healing but also sufficient to alter a relevant patient outcome positively, they do not justify the clinical use of ultrasound. Based on their clinical experiences, many therapists believe that ultrasound benefits healing.
Until methodologically adequate studies can demonstrate that people treated with active ultrasound consistently have a better outcome than those treated with placebo ultra-sound, we believe that doubts must remain. Another possible limitation is the particular criteria used as filters on the set of studies identified. Those criteria, however, are entirely consistent with other sets used in previous systematic reviews and meta-analyses. One possibly valid criticism of our review is that we did not apply the different filters with sufficient rigor.
For example, had studies that provided dubious or imprecise details of blinding of subjects, assessors, and therapists been excluded, few would have passed filter 2. Similarly, had the criterion regarding the establishment of controls filter 1 been rigorously applied, few studies would have passed, as many authors did not provide adequate details of how they randomly assigned subjects to groups.
Consistent with the possibility of a differential application of filters, there are some differences between this review and the review by van der Windt et al. Had we accepted those 2 studies, however, it would have made no difference to the outcome of this review, because both studies demonstrated no differences when using active ultrasound rather than placebo ultrasound. When methodologically flawed trials were excluded, there were few RCTs that investigated ultrasound and those RCTs provided little clinical evidence for the efficacy of therapeutic ultrasound.
The application of the exclusion criteria and methodological filters resulted in the elimination of all except 10 clinical ultrasound trials from the present review. Eight studies showed that active ultrasound is no more beneficial than placebo ultrasound for the treatment of people with pain or soft tissue injury.
Few generalizations can be drawn from the 2 trials in which active ultrasound was found to be superior to placebo ultrasound, given their heterogeneity and omission of important details. Consequently, there is still little evidence of the clinical effectiveness of therapeutic ultrasound as currently used by physical therapists to treat people with pain and musculoskeletal injuries and to promote soft tissue healing. There are, however, apparently considerably different beliefs as to what is an acceptable dosage.
The findings of the present review indicate the importance of systematically investigating the clinical effectiveness of therapeutic ultrasound and establishing whether there is a dose-response relationship. The first stage is to identify clinical problems for which ultrasound is anecdotally effective. The next stage should be to establish experimental and treatment protocols and standardized methods for ensuring the output of all ultrasound equipment used.
With sufficient such studies, meta-reviews should be possible and able to indicate more convincingly than systematic reviews the extent to which ultrasound affects clinical outcomes and under which conditions.
Dr Robertson provided project management and consultation including review of manuscript before submission. Nussbaum EL. There are no occasions where multiple high-quality studies exist for a single pathology, hence for any individual pathology there are low and very low levels of evidence.
In other words, this cannot yet be evidence-based medicine. As usual. Diane Jacobs, Canadian physiotherapist and writer. Patients often express irritation with a common physical therapy business model: working with several patients at once, rotating between rooms or beds, often leaving patients with passive therapies like a moist hot pack from a hydrocollator — nice enough, but worth a steep fee?
Many patients often go a step further and complain specifically about ultrasound and TENS, skeptical that these treatments really do anything. And so few patients are singing the virtues of standard US. It not only fails to generate testimonials, but actually generates many annoyed antimonials. Patients do not yet feel the same cynicism about shockwave ultrasound. As a more expensive and painful medicine, ESWT is a hope-generating machine. Having spent their hard-earned dollars and endured the discomfort of treatment, patients are more subject to expectation effects placebo — and much less willing to entertain the possibility that it was all a waste.
Few if any patients are out there singing the virtues of standard ultrasound. It not only fails to generate testimonials, but generates many bitter antimonials.
The big idea is — this will blow your mind! Oz Show. What, exactly, does vibration do to tissues? Does anyone actually understand it? In , Physical Therapy published a review of the biological effects of ultrasound. The frequently described biophysical effects of ultrasound either do not occur in vivo under therapeutic conditions or have not been proven to have a clinical effect under these conditions.
This review reveals that there is currently insufficient biophysical evidence to provide a scientific foundation for the clinical use of therapeutic ultrasound …. There is lots of interesting ultrasound biology to consider, and scientists may eventually nail down effects that might be the basis for new evidence-based therapies.
Another great example: the persistent hope that rattling cells with sonic vibrations might speed the healing of bone fractures, particularly low intensity pulsed ultrasound LIPUS. Such an effect, if proven, would certainly be a delightful bit of weird good news about biology. Unfortunately, it is probably dis -proven. In , the British Medical Journal published an excellent review with a very negative conclusion for fresh fractures. Meanwhile, there is still just no basis for thinking that ultrasound has a basis.
Therapeutic ultrasound is an ultra-popular modality commonly used in physiotherapy clinics for the treatment of muscle injuries and sprains. So what is therapeutic ultrasound TUS exactly and how does it work? Therapeutic ultrasound has been around for a long time since the 40s! If the ultrasound sound head is left in place on your skin and not moved in a circular direction, you may experience pain. If this occurs, tell your physical therapist right away. There are some instances where you should not use ultrasound at all.
These contraindications to ultrasound may include:. Usually, orthopedic injuries are treated with ultrasound. These may include:. Generally speaking, any soft-tissue injury in the body may be a candidate for ultrasound therapy. Your physical therapist may use ultrasound for low back pain, neck pain, rotator cuff tears, knee meniscus tears, or ankle sprains.
There is some evidence that if you have chronic pain, you may benefit from ultrasound treatments. It is thought that the ultrasound waves help improve tissue extensibility and circulation, leading to increased mobility and, ultimately, decreased pain. Ultrasound may not work for everyone, but it is worth a try if you have chronic, unremitting pain. Some people may argue that the benefit of ultrasound for chronic pain is due to the placebo effect.
But, if it gives you relief then it is the right treatment for you. If you are going to physical therapy and are getting an ultrasound, you should know that many studies have found that ultrasound offers little benefit to the overall outcome of physical therapy.
For example, if you have low back pain, ultrasound treatments have been shown to offer very little benefit. In fact, ultrasound received a grade of "C" no benefit demonstrated for knee pain, low back pain, and neck pain in a series of papers published in Physical Therapy Journal in A study in the American Journal of Physical Medicine and Rehabilitation examined the effect of ultrasound on pain and function in patients with knee osteoarthritis.
If your physical therapist is providing ultrasound for you, you may question if it is really necessary as part of your overall rehab program. Many people argue that ultrasound can have a negative effect on your physical therapy by needlessly prolonging your care. Ultrasound is a passive treatment. In other words, you can't provide the treatment yourself; you are simply a passive receiver of the ultrasound.
If your physical therapist uses ultrasound during your to treatment, make sure you are engaged in an active exercise program to help improve your functional mobility.
Exercise and active involvement should always be the main components of your rehab program. Your physical therapist may use ultrasound to help improve your condition. If so, be sure to ask about the need for ultrasound and possible risks. Also, be sure that you are also performing an active self-care exercise program in the PT clinic and at home.
If you are actively engaged in your rehabilitation, you can ensure that you have a safe and rapid recovery back to normal function. Get exercise tips to make your workouts less work and more fun.
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