1. Background To assess the efficacy of pulsed ultrasound as a treatment for idiopathic calcific tendinitis in a controlled trial.
Methods Patients with radiographically proven calcific tendinitis were assigned to receive minute sessions of either pulsed ultrasound (frequency, 0.89 MHz; intensity, 2.5 W/cm²; pulsed mode, 1:4) or an indistinguishable sham treatment to the area over the calcification. The first 15 treatments were given daily (five times per week), and the remainder were given three times a week for three weeks. Randomization was conducted according to shoulders rather than patient …
Conclusions In patients with symptomatic calcific tendinitis of the shoulder, ultrasound treatment helps resolve calcifications and is associated with short-
term clinical improvement.
Presentation: Lomg-term outcome of calcific tensinitis/ EbenbichlerLong term outcome of therapeut
Physical Medicine, Rehabilitation & Occupational Medicine

2. Long-term Outcome of Ultrasound Therapy for Calcific Tendinitis of the Shoulder: Results of a RCT
G. Ebenbichler¹, K. Pieber¹, M. Grim-Stieger¹, F. Kain-
berger², M. Funovics², E. Pablik³, K.-L. Resch⁴
Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, General Hospital of Vienna, Austria
Department of Osteoradiology, Medical University of Vienna, General Hospital of Vienna, Austria
Section for Medical Statistics, Center for Medical Statistics, Informatics and Intelligent Systems, Medical University of Vienna
Forschungsinstitut für Balneologie und Kurortwissenschaft, Bad Elster, Germany
Long term outcome of therapeutic US for calcific tendinitis/ Ebenbichler
Physical Medicine, Rehabilitation & Occupational Medicine

3. Background
Pain of the shoulder is widely believed to be caused by calcific tendinitis and may often be disabling (Lee SY et al., 2011).
A variety of non-surgical therapies are offered first line to patients with calcific tendinitis that all aim at resolving the calcium deposit, thereby likely improving effectively shoulder pain and function in the short term (e.g. Ebenbichler GR et al 1999, Pan PJ et al, 2003, Krasny C et al. 2005, Lee SY et al. 2011).
Uncertainty, however, seems to exist whether the calcium deposit would be causal in the recovery from symptoms and improvement of function in symptomatic calcific tendinitis (Cho NS et al. 2010).
Long term- monitoring of patients affected with symptomatic calcific tendinitis
could provide information on the relative contribution of rotator cuff calcifications to shoulder pain and impaired function (Gartner J & Simons B 1990).
could shed further light into a debate on the necessity to treat the calcium deposit as a potential source of nociceptive shoulder pain itself.

4. Objectives:
To follow the structure and function related ten-years’ outcome of shoulders that had been treated with therapeutic ultrasound (US) for symptomatic calcific tendinitis.
Of particular interest in this retrospective analysis was the sustainability of treatment effects that had been observed nine months after US therapy in order to better understand the nature of the problem.

5. Methods Patients: Eligibility: Inclusion criteria of the original RCT:
Shoulders of patients that had been enrolled in a RCT and had compared 24 sessions of 0.89 MHz pulsed ultrasound therapy with sham US therapy, who had completed therapy as allocated and for whom the nine months follow-up was available.
Inclusion criteria of the original RCT:
Diagnosis of calcific tendinitis type I or type II according to the classification by Gärtner and Heyer
Mild to moderate pain that had presented for more than four weeks or restricted range of movement of the affected shoulder
Exclusion criteria of the original RCT:
Systemic diseases associated with an increased risk of calcification (such as gout, hypercalcemia of any cause, and various rheumatic diseases),
Previous treatment of the shoulder with percutaneous needle aspiration, therapeutic US, or shock-wave therapy,
Injections of glucocorticoids in the shoulder within the three months preceding the study.

6. Methods: The ten-years’ examination
1) Measures of shoulder pain and function:
100-point Constant score (worst score = 0, best score = 100; Constant CR & Murley AH, 1987). The score assesses pain, tasks of daily living, active shoulder ROM, and shoulder muscle strength. Constant score > 90 was found to represent normal values in subjects aged between 51 and 60 years (Constant CR 1991).
The Binder score (Binder A et al., 1984). It assesses patients’ subjective symptoms including pain, pain on resisted movement (on internal, external rotation and active abduction). The best possible score is 0 and the worst possible score is 52.
The assessments were conducted by study physicians who were unaware of the treatment allocation of patients’ shoulder in the original RCT.
2) Structural integrity of the shoulders on X-ray imaging:
Standardized anteroposterior radiographs of both shoulders together with axial and outlet views were used for the assessment of calcium deposits (morphology and location) and of narrowing of the subacromial space.
Radiological assessment was performed independently by two experienced radiologists. In case of disagreement the radiographs were re-evaluated by the two radiologists in consensus.

7. Patients‘ Flow chart Enrollment Allocation End of Therapy
Enrolled and randomized (n=70 shoulders from 63 patients)
Allocated to sham-US (n=35)
Completed sham-US (n=29 shoulders)
Discontinued sham-US (n=6 shoulders)
n=29 shoulders
Lost to follow-up (n=6)
Analysed (n=20)
Lost to follow-up (n=5)
Analysed n=25 shoulders
Lost to follow-up (n=4)
Enrollment
Allocation
n=32 shoulders
End of Therapy
9 months’ Follow-Up after
Analysed n=31 shoulders
Lost to follow-up (n=1)
Analysed (n=28)
Lost to follow-up (n=3)
Allocated to US (n=35)
Completed US (n=32 shoulders)
Discontinued US (n=3 shoulders)
10 years‘ Follow-Up

8. Patients´ characteristics at baseline and at the ten-years´ follow-up evaluation
Mean±SD
Range N
Sex (female/male)
23/14
Age in years
49.1±10.6
28-77
BMI
24.8±3.4
19-35
Constant score (0-100)*
73.9±19.1
26-98
Binder score (0-52)**
22.5±9.7
2-40.7
Regular sportive activities 32
Patients’ characteristics at ten-years’ follow-up
25.8±4.1
20-39
Constant score*
92.4±12
50-100
Binder score**
5.3±9.2
0-39
Regular sportive activities (n#: US/sham US) 7
Further non-surgical treatments for shoulder complaints during the ten year follow-up
8/7
Shoulder pain ***(n#: US/sham US)
10/6
*The worst score is 0 and the best possible score is 100.
**The best possible score is 0 and the worst possible score is 52.
***Pain in the treated shoulder since the last follow-up evaluation nine months after treatment

9. Findings on X-ray at the ten years‘ follow-up
Type of calcification* I II
III
US treatment group (n=6/27; 22%) 1 4
Sham treatment group (n=3/18; 17%)

10. Numbers and respective percentage values of calcium deposits at baseline as at the end of the study (9 months follow-up) and at the 10 years follow-up of those shoulder that had been eligible for the long term- follow-up. 27 18 15 14 6 3
Please also note that among the previously verum US treated shoulders the number of calcium deposits given for the 10 years follow-up also includes 3 newly formed deposits after a complete resolution at 9 months.

11. US group Sham treated group Constant score Binder score
Constant score and Binder score of the shoulders that were included in the ten-years´ follow-up examination at baseline, at the nine-months´ follow-up and at the ten-years´ follow-up in the ultrasound (US) group and the sham treated group.
US group
Sham treated group
mean
95%CI SD
Constant score
Baseline
76.32
69.92 – 82.72
17.29
69.85
60.07 – 79.63
22.32
9 months
92.74
89.30 – 96.18
8.69
87.61
81.45 – 93.77
12.39
p=0.84 (Welch t-test)
10 years
94.00
90.26 – 97.74
9.66
90.10
83.27 – 96.93
14.60
p= 0.72 (Welch t-test)
Binder score
20.89
17.39 – 24.39
9.03
22.53
18.02 – 27.45
10.08
7.41
3.58 – 11.24
9.69
8.16
3.86 – 12.45
8.64
p= 0.96 (Welch t-test)
3.36
0.75 – 5.97
6.73
8.05
2.72 – 13.38
11.39
p= 0.44 (Welch t-test)
Welsh test compared the longitudinal changes relative to baseline Constant score and Binder score values between the US group and the sham treated shoulders as at the nine months´ and ten-years´ follow-up. Please note that at baseline neither the Constant score (p=0.29; Welch test) nor the Binder score (p=0.52; Welch test) differed significantly between the previously verum and sham treated shoulders.

12. Correlations: Calcium deposits - clinical findings:
Shoulders that had been treated in the original RCT: No correlation between calcium deposits and * Constant score (Spearman’s ρ=-0.063, p=0.59) * Binder score (Spearman’s ρ=0.047, p=0.69).

13. Conclusions
Patients who had been affected with symptomatic calcific tendinitis of the shoulder have a high likelihood that their calcium deposit will resolve, and that symptoms as well as shoulder function will return to normal in the long-term.
Therapeutic US may speed up this process.
However, the finding of a lack of association between shoulders identified with a calcification, and symptoms and/or impaired function at this long-term follow-up assessment challenges the prevailing opinion that treating the calcium deposit would be causal in the recovery from symptoms and improvement of function in these patients.

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