The New England Journal of Medicine
Ultrasound Therapy for Calcific Tendinitis of the Shoulder
Gerold R. Ebenbichler, M.D., Celal B. Erdogmus, M.D., Karl L. Resch, M.D., Martin A. Funovics, M.D., Franz Kainberger, M.D., Georg Barisani, M.D., Martin Aringer, M.D., Peter Nicolakis, M.D., GŁnther F. Wiesinger, M.D., Mehrdad Baghestanian, M.D., Elisabeth Preisinger, M.D., Veronika Fialka-Moser, M.D., and Reinhard Weinstabl, M.D.
Background and Methods Although ultrasound therapy is used to treat calcific tendinitis of the shoulder, its efficacy has not been rigorously evaluated. We conducted a randomized, double-blind comparison of ultrasonography and sham insonation in patients with symptomatic calcific tendinitis verified by radiography. Patients were assigned to receive 24 15-minute sessions of either pulsed ultrasound (frequency, 0.89 MHz; intensity, 2.5 W per square centimeter; 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 patients, so a patient with bilateral tendinitis might receive either or both therapies.
Results We enrolled 63 consecutive patients (70 shoulders). Fifty-four patients (61 shoulders) completed the study. There were 32 shoulders in the ultrasound-treatment group and 29 in the sham-treatment group. After six weeks of treatment, calcium deposits had resolved in six shoulders (19 percent) in the ultrasound-treatment group and decreased by at least 50 percent in nine shoulders (28 percent), as compared with respective values of zero and three (10 percent) in the sham-treatment group (P=0.003). At the nine-month follow-up visit, calcium deposits had resolved in 13 shoulders (42 percent) in the ultrasound-treatment group and improved in 7 shoulders (23 percent), as compared with respective values of 2 (8 percent) and 3 (12 percent) in the sham-treatment group (P=0.002). At the end of treatment, patients who had received ultrasound treatment had greater decreases in pain and greater improvements in the quality of life than those who had received sham treatment; at nine months, the differences between the groups were no longer significant.
Conclusions In patients with symptomatic calcific tendinitis of the shoulder, ultrasound treatment helps resolve calcifications and is associated with short-term clinical improvement.
American Academy of Family Physicians
Ultrasound Therapy for Calcific Tendonitis of the Shoulder
Calcific tendonitis of the shoulder most commonly affects the supraspinatus tendon and may cause pain and decreased range of motion. Treatment includes anti-inflammatory drugs, percutaneous needle aspiration and surgery. Ultrasound therapy is frequently used for a number of painful musculoskeletal disorders, but clinical efficacy for most applications has not been evaluated. Ebenbichler and colleagues conducted a sham-controlled study to evaluate the efficacy of pulse ultrasound therapy for calcific tendonitis.
The randomized, double-blind study was conducted in Vienna, Austria, and included 54 patients (61 shoulders). The diagnosis of calcific tendonitis was based on radiographic and ultrasonographic evidence of calcific tendonitis. The diameter of the calcification had to exceed 5 mm, and all patients had to have pain or restricted range of motion in the affected shoulder for at least four weeks. Exclusion criteria were a prior history of shoulder surgery, a corticosteroid injection within the past three months or the regular use of analgesics or anti-inflammatory drugs.
Ultrasound therapy was administered five times per week for three weeks, followed by three times weekly for three weeks, for a total of 24 treatments. Each session lasted 15 minutes. The primary outcome of the study was a radiographic change in the calcium deposits at the end of the 24 treatments and at a nine-month follow-up visit. Secondary outcomes included an assessment of pain in the shoulder, active range of motion, strength of the shoulder and the patient's ability to perform activities of daily living. A pain score was also used to evaluate outcome.
The ultrasound therapy group included 32 shoulders, and the sham treatment group included 29 shoulders. The mean age of patients in the ultrasound group was 49 years and the mean age of those in the sham group was 54 years.
Radiologic evaluation of the ultrasound group revealed that the calcium deposits had resolved in six shoulders (19 percent) and had decreased by at least 50 percent in nine shoulders (28 percent). In the sham treatment group, calcium deposits did not resolve in any patient and decreased by at least 50 percent in three (10 percent) of the shoulders. At the nine-month follow-up evaluation, calcium deposits had resolved in 13 (42 percent) of the shoulders in the ultrasound treatment group. An additional seven shoulders (23 percent) were found to demonstrate improvement. In contrast, in the sham treatment group resolution occurred in two shoulders (8 percent) and improvement was noted in three shoulders (12 percent).
Clinical improvement was significantly more common in the ultrasound therapy group than in the sham treatment group. Twenty-nine shoulders (91 percent) in the ultrasound group demonstrated improvement, compared with 15 shoulders (52 percent) in the sham treatment group. The ultrasound group had a greater decrease in pain and more improvement in quality of life.
The authors conclude that ultrasound therapy is of definite benefit in patients with symptomatic calcific tendonitis. It helps eliminate the calcifications and provides at least short-term symptomatic relief. These findings are consistent with several other studies. The authors note that the way in which ultrasound stimulates resorption of calcium deposits is not known. It may increase blood flow and metabolism in the affected area, thus facilitating disintegration of calcium deposits.
JEFFREY T. KIRCHNER, D.O
Noninvasive Ultrasound Treatment Shrinks Fibroids
CHICAGO - A totally noninvasive procedure using high-intensity ultrasound waves to heat and destroy uterine fibroid tissue significantly relieves fibroid-related symptoms in women, according to the results of a multicenter clinical trial. Magnetic resonance-guided, focused ultrasound surgery (MRgFUS) allows radiologists to precisely target fibroids without harming healthy surrounding tissue. The study was presented today at the annual meeting of the Radiological Society of North America (RSNA).
"This treatment immediately stops blood flow in the fibroid tissue, which results in a significant, sustained decrease in symptoms for up to 12 months," said the study's lead author, Fiona M. Fennessy, M.D., Ph.D., instructor of radiology at Harvard Medical School and staff radiologist at Brigham and Women's Hospital in Boston.
Uterine fibroids are benign growths of the muscle inside the uterus. According to the National Institutes of Health, at least 25 percent of women in the United States age 25 to 50 suffer from uterine fibroids, and as many as 50 percent of African American women have uterine fibroids.
Symptoms can include excessive menstrual bleeding, enlarged uterine size, frequent urination, pelvic pressure or pain and infertility. The absolute treatment for symptomatic fibroids is hysterectomy, which is the complete removal of the uterus. According to the National Women's Health Information Center, fibroids are the primary reason for hysterectomy, accounting for 175,000, or approximately one-third, of hysterectomies performed annually in the United States.
"Hysterectomy is currently the gold standard of therapy for uterine fibroids," Dr. Fennessy said. "However, women are increasingly seeking minimally invasive or noninvasive alternatives to hysterectomy."
Dr. Fennessy and colleagues studied 160 women with symptomatic fibroids treated as part of a clinical trial at five medical centers. The women received pre-treatment MR imaging to identify and define the target fibroids for MRgFUS. Radiologists then used focused ultrasound to deliver heat to the targeted fibroid volume. Temperature-sensitive MR guidance allowed the team to monitor the location of the ultrasound beam and to track temperature changes in tissue during the procedure.
One hundred eleven patients were treated under the original study protocol (A), and 51 patients were treated under an optimized protocol (B). Protocol A allowed a maximum treatment time of 120 minutes or a maximum treatment volume of 100ccs (roughly six centimeters (cm) in diameter), or up to 33 percent of total fibroid volume. Protocol B allowed a maximum treatment time of 180 minutes and maximum treatment volume of 150ccs (about 7 cm in diameter), or up to 33 percent of total volume in subserosal fibroids (those on the outer wall of the uterus) and 50 percent of volume in non-subserosal fibroids.
Treatment outcomes were assessed by Uterine Fibroids Symptoms and Quality of Life (UFSQOL) scores obtained at baseline, three, six and 12 months post-treatment. The findings showed significant symptom relief at three and six months and sustained relief at one year. Women treated with the optimized protocol reported greater symptom relief and quality of life improvement than those treated with the original protocol. No serious adverse effects were reported. Initial findings in follow-up of patients 24 and 36 months after treatment suggest that symptom relief is maintained.
"We have shown that treating fibroids with an optimized, less restrictive protocol allows for treatment of a greater fibroid volume, which results in even greater symptomatic relief at clinical follow-up," Dr. Fennessy said.
Co-authors are Clare M. Tempany, M.D., Kelly H. Zou, Ph.D., Minna J. So, M.D., Elizabeth A. Stewart, M.D., Frank J. Rybicki, M.D., Ph.D., Nathan J. McDannold, Ph.D., Kullervo Hynynen, Ph.D., Gina K. Hesley, M.D., and Ferenc A. Jolesz, M.D.