Clinical Health Updates

Zoledronic acid reduces fracture risk in osteoporosis, osteopenia with previous fracture

Clinical Question:
Is zoledronic a safe and effective drug for preventing fractures in women with osteoporosis?

Bottom Line:
Zoledronic acid (Zometa) given once a year via intravenous infusion reduces the risk of clinical fracture in women with osteoporosis or osteopenia and previous fracture. Approximately 1 in 100 women will develop atrial fibrillation, though, as a result of treatment.

Reference:
Black DM, Delmas PD, Eastell R, et al, for the HORIZON Pivotal Fracture Trial. Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis. N Engl J Med 2007;356:1809-1822.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
Zoledronic acid is a bisphosphonate that has primarily been used in patients with multiple myeloma and in cancer patients with hypercalcemia. In this study, 7765 women between the ages of 65 years and 89 years with either osteoporosis (T score at femoral neck < -2.5) or osteopenia (T score < -1.5) and evidence of previous vertebral fracture were randomly assigned to receive either zoledronic acid 5 mg given intravenously at baseline, 12 months, and 24 months or matching placebo. All patients received 1000 mg to 1500 mg of calcium and 400 IU to 1200 IU of vitamin D daily. Patients were allowed to take nonbisphosphonate drugs for the treatment of osteoporosis. Approximately 600 women in each group did not return for the final evaluation. Groups were similar at baseline and analysis was by intention to treat. Approximately 80% of the women were not taking any other osteoporosis drugs; of those who were, raloxifene was the most commonly used (42%).

Patients receiving zoledronic acid had fewer hip fractures (1.4% vs 2.5%; P = .002; number needed to treat [NNT] = 111 for 3 years) and fewer clinical vertebral fractures (0.5% vs 2.6%; P < .001; NNT = 48) and fewer clinical fractures of any type (8.4% vs 12.8%; P < .001; NNT = 23). Although patients taking the drug had transient increases in serum creatinine, at the end of the study there was no difference in renal function between groups. Atrial fibrillation was also more common in women taking zoledronic acid (1.3% vs 0.5%; P < .001; NNH = 125). This has also been previously reported in a study of alendronate, although more data are needed. There was no difference between groups regarding other cardiovascular events or all-cause mortality and no instances of osteonecrosis of the jaw.

Proprioceptive training decreases recurrent ankle sprains

Clinical Question:
Do male soccer players with previous inversion ankle sprains have fewer sprains if they engage in proprioceptive training, strength training, or if they use an orthotic?

Bottom Line:
In this small unblinded study, proprioceptive training, compared with no intervention, was an effective strategy to reduce the rate of ankle sprains among male soccer players who suffered ankle sprain.

Reference:
Mohammadi F. Comparison of 3 preventive methods to reduce the recurrence of ankle inversion sprains in male soccer players. Am J Sports Med 2007;35:922-926.

Study Design:
Randomized controlled trial (nonblinded)

Synopsis:
Ankle sprains are frequent injuries in soccer. Several strategies can be used to prevent further ankle sprains in athletes: the most common are proprioceptive training, strength training, and orthoses. The authors were kin to investigate which of these 3 interventions is the most effective in preventing ankle sprains in athletes with previous ankle inversion sprain. They did a randomized controlled trial. Eighty male soccer players (age, 24.6 +/- 2.63 years; height, 175.60 +/- 4.36 cm; weight, 64.26 +/- 8.37 kg) in the first division of a men’s league who had experienced previous ankle inversion sprain were randomly selected from an original population of 120 players. The subjects were individually and randomly assigned to 4 study groups: group 1 (n = 20) followed the proprioceptive program, group 2 (n = 20) followed the strength program, group 3 (n = 20) used orthoses, and group 4 (n = 20) was the control group. Data on the frequency of ankle sprain reinjury were collected at the end of the session. There were no significant differences among the groups in the number of exposures. The incidence of ankle sprains in players in the proprioception training group was significantly lower than in the control group (relative risk of injury, 0.13; 95% confidence interval, 0.003-0.93; P = .02). The findings with respect to the strength and orthotic groups in comparison with the control group were not significant (relative risk of injury, 0.5; 95% confidence interval, 0.11-1.87; P = .27 for strength; relative risk of injury, 0.25; 95% confidence interval, 0.03-1.25; P = .06 for orthotic group).

ESWT improves chronic patella tendonitis

Clinical Question:
Does extracorporeal shockwave therapy improve symptoms in patients with chronic patella tendonitis?

Bottom Line:
In this flawed study, extracorporeal shockwave therapy appeared to be more effective and safer than traditional conservative treatments in the management of patients with chronic patellar tendinopathy.

Reference:
Wang CJ, Ko JY, Chan YS, Weng LH, Hsu SL. Extracorporeal shockwave for chronic patellar tendinopathy. Am J Sports Med 2007;35:972-978.

Study Design:
Non-randomized controlled trial

Synopsis:
Chronic patellar tendinopathy is an overuse syndrome with pathologic changes similar to tendinopathies of the shoulder, elbow, and heel. Extracorporeal shockwave was shown effective in many tendinopathies. The authors investigated whether extracorporeal shockwave therapy may be more effective than conservative treatment for chronic patellar tendinopathy. They did a randomized controlled clinical trial; Level of evidence, 2. This study consisted of 27 patients (30 knees) in the study group and 23 patients (24 knees) in the control group. In the study group, patients were treated with 1500 impulses of extracorporeal shockwave at 14 KV (equivalent to 0.18 mJ/mm(2) energy flux density) to the affected knee at a single session. Patients in the control group were treated with conservative treatments including nonsteroidal anti-inflammatory drugs, physiotherapy, exercise program, and the use of a knee strap. The evaluation parameters included pain score, Victorian Institute of Sports Assessment score, and ultrasonographic examination at 1, 3, 6, and 12 months and then once a year. At the 2- to 3-year follow-up, the overall results for the study group were 43% excellent, 47% good, 10% fair, and none poor. For the control group, the results were none excellent, 50% good, 25% fair, and 25% poor. The mean Victorian Institute of Sports Assessment scores were 42.57 +/- 10.22 and 39.25 +/- 10.85, respectively, before treatment (P = .129) and 92.0 +/- 10.17 and 41.04 +/- 10.96, respectively, after treatment (P < .001). Satisfactory results were observed in 90% of the study group versus 50% of the control group (P < .001). Recurrence of symptoms occurred in 13% of the study group and 50% of the control group (P = .014). Ultrasonographic examination showed a significant increase in the vascularity of the patellar tendon and a trend of reduction in the patellar tendon thickness after shockwave treatment compared with conservative treatments. However, no significant difference in the appearance, arrangement, and homogeneity of tendon fibers was noted between the 2 groups. There were no systemic or local complications or device-related problems.

Tennis elbow: injection better short-term, worse long-term

Clinical Question:
Is a steroid injection or physical therapy more effective than general treatment in patients with tennis elbow?

Bottom Line:
Physiotherapy combining elbow manipulation and exercise has a superior benefit to wait and see in the first six weeks and to corticosteroid injections after six weeks, providing a reasonable alternative to injections in the mid to long term. The significant short term benefits of corticosteroid injection are paradoxically reversed after six weeks, with high recurrence rates, implying that this treatment should be used with caution in the management of tennis elbow.

Reference:
Bisset L, Beller E, Jull G, Brooks P, Darnell R, Vicenzino B. Mobilisation with movement and exercise, corticosteroid injection, or wait and see for tennis elbow: randomised trial. BMJ 2006;333:939.

Study Design:
Randomized controlled trial (single-blinded)

Synopsis:
To investigate the efficacy of physiotherapy compared with a wait and see approach or corticosteroid injections over 52 weeks in tennis elbow. The authors did a single blind randomised controlled trial. In a community setting, Brisbane, Australia consiting of 198 participants aged 18 to 65 years with a clinical diagnosis of tennis elbow of a minimum six weeks’ duration, who had not received any other active treatment by a health practitioner in the previous six months. Eight sessions of physiotherapy; corticosteroid injections; or wait and see. Global improvement, grip force, and assessor’s rating of severity measured at baseline, six weeks, and 52 weeks. Corticosteroid injection showed significantly better effects at six weeks but with high recurrence rates thereafter (47/65 of successes subsequently regressed) and significantly poorer outcomes in the long term compared with physiotherapy. Physiotherapy was superior to wait and see in the short term; no difference was seen at 52 weeks, when most participants in both groups reported a successful outcome. Participants who had physiotherapy sought less additional treatment, such as non-steroidal anti-inflammatory drugs, than did participants who had wait and see or injections.

Effective methods for preventing pressure ulcers

Clinical Question:
Which interventions are effective for the prevention of pressure ulcers?

Bottom Line:
Given current evidence, using support surfaces, repositioning the patient, optimizing nutritional status, and moisturizing sacral skin are appropriate strategies to prevent pressure ulcers. Although a number of RCTs have evaluated preventive strategies for pressure ulcers, many of them had important methodological limitations. There is a need for well-designed RCTs that follow standard criteria for reporting nonpharmacological interventions and that provide data on cost-effectiveness for these interventions.

Reference:
Reddy M, Gill SS. Rochon PA. Preventing pressure ulcers: a systematic review. JAMA 2006;296:974-984.

Study Design:
Systematic review

Synopsis:
Multiple preventive approaches are used in the management of pressure ulcers. These authors systematically searched multiple evidence-based databases including the Cochrane Registry, bibliographies of identified articles, and scientific meeting abstracts for randomized controlled trials (RCTs) evaluating preventive measures for pressure ulcers. No language restrictions were applied. They used standard methods to critically appraise individual RCTs. The search strategy identified 763 citations, from which 59 trials meeting eligibility criteria were selected. The methodologic quality of the RCTs was generally suboptimal. Interventions were grouped into 3 categories: those addressing impairments in (1) mobility, (2) nutrition, and (3) skin health. Effective strategies for those with impaired mobility included the use of support surfaces (mattresses, beds, and cushions), mattress overlays on operating tables, and specialized foam and sheepskin overlays. Frequent repositioning is effective, but the optimal schedule for turning (every 2 vs every 4 hours) is uncertain. Nutritional supplements are beneficial in patients with impaired nutrition. Simple skin moisturizers, specifically to the sacral area, were helpful, but the incremental benefit of other specific topical agents is minimal.

Balance exercise program prevents ankle sprains

Clinical Question:
Are balance exercises more effective at preventing ankle sprains than traditional strength and conditioning exercises among high school athletes?

Bottom Line:
A balance training program will significantly reduce the risk of ankle sprains in high school soccer and basketball players.

Reference:
McGuine TA, Keene JS. The effect of a balance training program on the risk of ankle sprains in high school athletes. Am J Sports Med 2006;34:1103-1111.

Study Design:
Randomized controlled trial (nonblinded)

Synopsis:
These researchers conducted a cluster randomized trial in which 55 high school soccer and basketball teams (523 girls, 242 boys) were randomized to either their usual strength and conditioning program or to a 5-phase balance program. Phases 1-4 each lasted 1 week and were completed prior to the start of their season. The fifth phase was a maintenance phase in which subjects performed the exercises 3 times each week for 10 minutes throughout the competitive season. The program began with open-eye training on the floor and increased in complexity, ending with closed-eye exercises on a balance board. Since the rate of ankle sprains is a function of exposures, the athletic trainers at the schools tracked all coach-directed competition, practice, or conditioning sessions. In addition to measuring the rate of ankle sprains (assessed via intention to treat), they determined severity on the basis of the number of days lost to sports: minor (1-7 days); moderate (8-21 days); severe (more than 21 days). To return to play, injured athletes needed: (1) approval by the athletic trainer and physician; (2) full ankle strength and pain-free range of motion; and (3) the ability to complete a series of functional activities similar to the demands of his or her individual sport. The intervention group sustained fewer sprains (6.1%, 1.13 per 1000 exposures) than the control group (9.9%, 1.87 per 1000 exposures). One would need to treat 26 high school soccer and basketball players with this program to prevent 1 sprain per season. The authors report that the program was more effective in preventing sprains in athletes with prior sprains, however, the study was not powerful enough to determine if the program was also effective in the primary prevention of sprains. There was no statistically significant difference in sprain severity, but the study lacked the power for this to be conclusive.