Therapeutic Ultrasound for Chemotherapy-Related Pain and Sensory Disturbance in the Hands and Feet in Patients With Colorectal Cancer: A Pilot Randomized Controlled Trial.

CONTEXT: This proof-of-concept trial was undertaken as a first step in exploring the clinical benefit of therapeutic ultrasound for pain and sensory disturbance in patients with colorectal cancer.

OBJECTIVES

The aim of this study was to determine the feasibility and preliminary efficacy of adding therapeutic ultrasound to a home-based therapeutic exercise program (current standard of care) for patients presenting with oxaliplatin-related pain and sensory disturbance in the hands and feet.

METHODS

Thirty-one colorectal cancer patients with presenting symptoms of peripheral sensory neuropathy, based on a physician-rated grade 1, 2, or 3 on the National Cancer Institute Common Terminology Criteria for Adverse Events for sensory and motor neuropathy, were enrolled in the trial. Patients were randomized to either 10 sessions of ultrasound therapy intervention over two-week period (continuous ultrasound at an intensity of 0.7 to 0.8 w/cm2, and frequency of 3 MHz for 5 minutes) plus standard care (n = 16) or to standard care alone (n = 15). The feasibility of therapeutic ultrasound was determined by the recruitment rate, participants' adherence to the intervention, and the study completion rates. Assessments of pain, sensory disturbance, sensation, and balance were conducted at baseline, two and six weeks.

RESULTS

We achieved a recruitment rate of 84%, an adherence rate of 100% to the intervention, and a completion rate of 100%. Adding therapeutic ultrasound to standard care resulted in a statistically and clinically significant improvement in symptoms of pain and sensory disturbance (P = 0.003) at two weeks; however, no significance difference between the groups was found at the six-week follow-up.

CONCLUSIONS

The findings of this proof-of-concept study support the feasibility of the therapeutic ultrasound in addition to standard care as an intervention for colorectal cancer patients with oxaliplatin-related pain and sensory disturbance in the hands and feet. The findings warrant a large-scale placebo-controlled trial.