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Original Research |
1 Department of Orthopaedic Surgery, Academic Medical Center, Meibergdreef 9, PO
Box 22660, 1100 DD Amsterdam, The Netherlands.
2 School for Medical Imaging and Radiodiagnostic Studies, Haarlem, The
Netherlands.
3 Division of Public Health, Department of General Practice, Academic Medical
Center, Amsterdam, The Netherlands.
Received April 26, 2004;
revised November 23, 2004;
This study was partly funded by Bauerfeind, manufacturer of orthotic
devices.
Abstract
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SUBJECTS AND METHODS. Patients with tennis elbow complaints were randomized. Sonography was performed before randomization in 57 patients. Outcome measures at 6 weeks' follow-up were success rate and decrease in pain (scale, 0–100). Data were analyzed using an intention-to-treat analysis.
RESULTS. In only 75% of the imaged patients, sonographic abnormalities were identified and the clinical diagnosis could thus be confirmed. The following entities were identified: hypo- and hyperechogenicity, swelling, calcification, bursitis, enthesopathy, and tendinosis. The positive predictive value of sonography for the different entities varied between 0.78 and 0.82, and the negative predictive value ranged between 0.23 and 0.71. Predictive value was studied by subgroups of sonographic findings: hypoechoic, swelling present, enthesopathy, any entity present, and no entity present. We found no significant differences among the subgroups for either success rate (range, 40–54%) or mean decrease in pain (range, 16–28 percentage points).
CONCLUSION. No predictive value of sonography for the detection of abnormalities was identified in this study. Its diagnostic capability showed limited value. However, limitations in this study necessitate drawing definitive conclusions with care.
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In the literature, more than 40 treatment options have been described [9]. Examples include an expectant waiting policy, corticosteroid injections, orthotic devices, and physical therapy. Surgery may be used for chronic, disabling cases. In Dutch primary care, 21% of the patients with lateral epicondylitis are prescribed an orthotic device as a treatment strategy, and physical therapy is prescribed in approximately 28% of the patients [1, 10].
Diagnostic imaging methods, such as sonography, have not been used to support the choice among different treatment strategies for tennis elbow. Maffulli et al. [11] reported the sonographic findings in patients with tennis elbow and showed that six different entities could be identified: enthesopathy, tendinitis, peritendinitis, bursitis, intramuscular lesions, and mixed lesions. Maffulli et al. reported the possible prognostic value of sonography as a diagnostic tool in patients with tennis elbow. Because sonography is a relatively cheap diagnostic tool, it might be useful for supporting choice of therapy. In the current study, the primary aim was to determine within a trial the prognostic value of sonographic findings and the correlation of findings with effectiveness of three conservative treatment strategies: brace only, physical therapy only, and a combination of both.
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The hospital's medical ethics committee approved the study, and informed consent was obtained from all patients.
Study Design
Baseline assessments were performed by a resident orthopedic surgeon before
randomization in a blinded setting. Assessments included patient demographics,
comorbidity, and baseline values of the outcome measures. After informed
consent was obtained, patients were included in the trial by a researcher and
randomized using a computer program with minimization strategy and
prestratification for the duration of complaints (i.e., < 3, 3–6, and
> 6 months) [12]. Both
patient and researcher were able to see the allocated treatment on the
computer screen. Patients were allocated to brace only, physical therapy only,
or a combination of brace and physical therapy. From a random sample of 75
nonconsecutive patients, sonographic images of both arms were obtained by a
trained sonographer using a 7.5-MHz linear-array transducer (SSD-900, Aloka).
This examination was performed at baseline, 6, 26, and 52 weeks. A
standardized imaging protocol was used in which a good view of the tendon was
achieved in both longitudinal and transverse planes. These images were
evaluated by another sonographer without knowledge of either the injured side
or the assigned treatment. This was done in a blinded manner and not real-time
to ensure a blinded evaluation and prevent introduction of bias concerning the
injured side and type of treatment.
Evaluation was performed using a standardized scoring form. Echogenicity was characterized as hypoechogenic, normal, or hyperechogenic. Swelling (present or not present) of the tendon itself was evaluated. The threshold was a relative increase of more than 30% of the tendon thickness compared with the healthy side. Calcifications (present or not present) [9] were assessed. Bursitis, bursa under the inferior surface of the extensor carpi radialis brevis tendon, was characterized as present or not present. Finally, the location of the lesion [1, 13] was evaluated as enthesopathy (proximal part of the tendon enlarged with alterations in echogenicity), tendinosis (extensor carpi radialis brevis tendon enlarged with alterations in echogenicity and loss of normal tendon structure), or peritendinosis (thickening of the peritendinous lining).
Treatment
Patients in the combination group received the combination of both the
protocols described.
Patients in the brace-only group were provided with the brace immediately after randomization. The brace used was the Epipoint (Bauerfeind), and patients were instructed immediately in its use and application using a standardized protocol. Patients in the brace-only group were instructed to visit a physical therapist participating in the trial once during the first week of the intervention period. Patients were advised to wear the brace continuously during the daytime, especially when performing activities that they thought could provoke pain, for the 6-week intervention period. Activities causing pain despite the use of the brace were discouraged.
Patients in the physical therapy–only group were treated by a standardized protocol. During the 6-week intervention period, patients underwent a total of nine sessions: three sessions per week for the first week, two sessions per week for the second week, and one session per week for the last 4 weeks. Every session consisted of a 7.5-min pulsed ultrasound treatment according to the protocol by Binder et al. [14]. In addition, patients were treated by friction massage for 5–10 min. Patients were instructed by the physical therapist to perform a strengthening and stretching protocol at home twice daily when pain had subsided [15].
Outcome Assessment
Outcomes were assessed at 6 weeks after randomization. The outcome measures
used were global improvement and pain intensity. Global improvement was
assessed on a 6-point scale (1, completely recovered; 2, much improved; 3,
little improved; 4, not changed; 5, a little worse; 6, much worse). This
measure was dichotomized: patients reporting to be completely recovered or
much improved were noted as a success. The pain intensity of the patient's
most important complaint was rated on an 11-point scale (0, no pain; 10,
severe pain). The results were converted to a 100-point scale.
Statistical Analysis
Clinical data were analyzed using an intention-to-treat analysis
[16]. The diagnostic abilities
of sonography were evaluated comparing the images of the injured arm and using
images of the noninjured arm as a control group. The predictive value of
sonography was determined by comparing different subgroups based on sonography
entities. Differences in continuous outcome measures (numeric rating scale)
were compared using independent t tests in cases of normal
distribution. When distribution of data was not normal, the Mann-Whitney test
was applied. Global improvement was analyzed using chi-square tests (Fisher's
exact test).
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Diagnostic Value
Injured arm—When echogenicity of the images was evaluated
(Table 2), a hypoechoic area
was visualized in 38 patients (67%) and a hyperechoic area was seen in three
patients. Enthesopathy was diagnosed in 37 patients (65%) and tendinitis in 11
patients (19%). In 14 patients (25%), no abnormality was detected.
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Noninjured arm—In 11 (19%) of 57 noninjured arms, a hypoechoic area in the tendon was seen. In the remaining 46 patients, no abnormalities were visualized.
Diagnostic Value
In Table 3, the diagnostic
value per entity of the injured arm is described. Enthesopathy had the highest
positive (0.82) and negative (0.71) predictive values. This entity also has
the highest likelihood ratio (4.64) (Figs.
1A,
1B and
2A,
2B).
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Prognostic Value
Baseline clinical results are presented in
Table 4. Subgroup analyses were
made for five subgroups: hypoechoic image, swelling present, enthesopathy, any
entity present, or no entity present. None of these subgroups showed
statistically significant differences for success rate or for mean improvement
of pain on the short-term (6 weeks), intermediate-term (26 weeks)
(Table 5), or long-term (52
weeks) (Table 6) evaluations.
Success rates in groups 1–4 varied between 40% and 54%
(Fig. 3). The success rate in
the no-entity group was 29%. The decrease in pain varied in groups 1–4
from 26 to 28 percentage points and was 16 percentage points in the no-entity
group. These results differed, but the differences are not statistically
significant.
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When success rates and pain improvement scores were compared among all the different entity groups, no statistically significant differences were identified. Hence, none of the sonography-identified subgroups differed in prognosis.
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Concerning the diagnostic value of sonography for tennis elbow in our study, we found that sonographic abnormalities were identified and the clinical diagnosis thus confirmed in only 75% of the imaged patients. The following entities were identified: hypo- or hyperechogenicity, swelling, calcification, bursitis, enthesopathy, and tendinosis. The positive predictive value of different sonography entities varied between 0.78 and 0.82, whereas the negative predictive value ranged between 0.23 and 0.71.
The predictive value of the different studied subgroups: hypoechoic, swelling present, enthesopathy, any entity present, or no entity present; showed no significant differences for either success rate (range, 40–54%) or mean decrease in pain (range, 16–28%).
A notable finding was the relatively low success rate in the no-entity subgroup. No significant differences, however, could be identified. It seems logical that prognosis of treatment is worse in patients in whom no abnormality is found because treatment might be aimed at the wrong pathoanatomic substrate. However, caution should be applied in drawing definitive conclusions about these findings. The study is of limited size. Different subgroups identified might be too small to identify differences in prognosis. Evaluation based on printed images is an additional limitation of this study. Because sonography is a dynamic diagnostic tool, real-time evaluation could lead to a different interpretations of sonographic findings.
Maffulli et al. [11] were among the first to report the sonographic findings for tennis elbow. They showed different pathologic entities in patients with tennis elbow. Maffulli et al. stated that sonography may have a possible prognostic value. Our hypothesis was that these different pathologic entities are predictive factors for the effectiveness of different conservative treatment strategies. The results of our study do not confirm this hypothesis. Maffulli et al. were able to confirm the diagnosis by sonographic abnormalities in 93% of their patients. In our study, this was possible in 75% of the patients. A recent publication by Miller et al. [17] reported a sensitivity of 64–82% and a specificity ranging from 67% to 100% between two independent reviewers. However, only 10 patients were evaluated. Connell et al. [18] concluded that sonography is valuable in confirming the diagnosis of lateral epicondylitis. Of the 75 patients they reviewed, only four patients had normal-appearing tendons, so diagnosis was confirmed in 95% of the patients, which is considerably more than our 75%. As in our study, Connell et al. found a hypoechoic appearance to be the most common finding. In 64% of their patients, this entity was found, compared with 67% in our study. In 10 healthy volunteers (13%) they examined, no abnormalities were found, in contrast to 19% of our control patients.
A possible explanation for the low percentage of sonographic confirmation for the diagnosis of tennis elbow might be the relatively mild complaints of the patients in our study. Another explanation might be a difference in the technical parameters for the sonography equipment used, causing abnormalities to be beyond the resolution of the scanner used. We believe that this is the main reason because the equipment used was not comparable to the current state-of-the-art equipment. In addition, our findings differed slightly from those of Maffulli et al.—in particular, concerning the locations of the lesions.
Recent developments in sonography are the introduction of power Doppler imaging, which is now more and more frequently used to detect inflammation—for instance, synovial inflammation [19, 20]. This type of imaging might be valuable as a diagnostic, and possibly prognostic, tool in tennis elbow as well.
In conclusion, because sonography is used more and more in physical therapy practices, family practices, and outpatient orthopedic clinics, study of its prognostic value for patients with tennis elbow is of great importance. The results of our study showed that sonography has no prognostic value for predicting the effectiveness of brace only, physical therapy only, or a combination of these strategies in patients with tennis elbow and that it could not be used to identify a category of patients with a clear favorable or bad prognosis in general. Our study has several limitations. If recently introduced, more advanced sonography equipment were used, abnormal findings may be found in a higher number of patients. A future study should also incorporate real-time evaluation of imaging and a larger variety of treatments, including a wait- and-see strategy and corticosteroid injections.
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  B K Coombes, L Bisset, and B Vicenzino A new integrative model of lateral epicondylalgia Br. J. Sports Med., April 1, 2009; 43(4): 252 - 258. [Abstract] [Full Text] [PDF]
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