Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial.

OBJECTIVE: Evaluate the efficacy and safety/tolerability of cryoneurolysis for reduction of pain and symptoms associated with knee osteoarthritis (OA). DESIGN: Randomized, double-blind, sham-controlled, multicenter trial with a 6-month follow-up in patients with mild-to-moderate knee OA. Patients were randomized 2:1 to cryoneurolysis targeting the infrapatellar branch of the saphenous nerve (IPBSN) or sham treatment. The primary endpoint was the change from baseline to Day 30 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain score adjusted by the baseline score and site. Secondary endpoints, including visual analogue scale (VAS) pain score and total WOMAC score, were tested in a pre-defined order. RESULTS: The intent-to-treat (ITT) population consisted of 180 patients (n = 121 active treatment, n = 59 sham treatment). Compared to the sham group, patients who received active treatment had a statistically significant greater change from baseline in the WOMAC pain subscale score at Day 30 (P = 0.0004), Day 60 (P = 0.0176), and Day 90 (P = 0.0061). Patients deemed WOMAC pain responders at Day 120 continued to experience a statistically significant treatment effect at Day 150. Most expected side effects were mild in severity and resolved within 30 days. The incidence of device- or procedure-related adverse events was similar in the two treatment groups with no occurrence of serious or unanticipated adverse device effects (ADE). CONCLUSIONS: Cryoneurolysis of the IPBSN resulted in statistically significant decreased knee pain and improved symptoms compared to sham treatment for up to 150 days, and appeared safe and well tolerated.

The manager and pain control for patients.

Every day seems to bring new demands for health services managers, even though none of the existing expectations seems to end. But, an effective pain management program is basic to meeting patient needs and is driven by patients' judgments and demands. It remains for HSOs and their managers to determine the means by which patients' judgments and demands will be met.

Acute care hospitals and community health.

Hospital boards and executives must resist the pressure to become all things health in the community. Hospital executives must educate their boards about the importance of concentrating on their core business and avoiding entangling and potentially risky ventures in peripheral and unrelated activities. They can and should participate in community health initiatives, but such efforts should, at most, be incidental to delivery of acute care services. The Drucker quote at the beginning of this column should be a warning to all who would venture even a short distance from their core business.

Implementing advance directives: a continuing problem for provider organizations.

It has been suggested that widespread use of advance directives might encourage systematic rationing of healthcare, especially to the elderly. If a right to die becomes a duty to die, the living will and its progeny have become a Frankenstein monster. Indeed, public statements by state and federal officials that the elderly should be required to have living wills raised a storm of protest in the past. Regardless of true motives, such suggestions tend to be seen by the public as motivated by economics. The organization must be alert to the issues raised by advance directives. Managers are obliged to obey the law. Beyond that, however, they should work to enhance patient autonomy by facilitating preparation and availability of advance directives and surrogate decision making, should that become necessary.