Pilot evaluation of Scrambler therapy for the treatment of chemotherapy-induced peripheral neuropathy

Abstract

Purpose: Chemotherapy-induced peripheral neuropathy (CIPN), a common side effect of chemotherapy, needs better effective treatments. Preliminary data support the use of Scrambler therapy, a device which treats pain via noninvasive cutaneous electrostimulation, for the treatment of CIPN. The current manuscript reports data from a pilot trial, performed to investigate the effect of Scrambler therapy for the treatment of established CIPN.

Methods: Eligible patients had CIPN symptoms of ≥1 month duration with tingling and/or pain ≥4/10 during the prior week. Patients were treated with Scrambler therapy to the affected area(s) for up to ten daily 30-min sessions. Symptoms were monitored using a neuropathy questionnaire consisting of numerical analog scales ranging from 0 to 10, daily before therapy as well as weekly for 10 weeks after therapy. Descriptive summary statistics formed the basis of data analysis.

Results: Thirty-seven patients were enrolled. Twenty-five patients were treated primarily on their lower extremities while 12 were treated primarily on their upper extremities. There was a 53 % reduction in pain score from baseline to day 10; a 44 % reduction in tingling; and a 37 % reduction in numbness. Benefit appeared to last throughout 10 weeks of follow-up. There were no substantial adverse events.

Conclusion: Preliminary data support that Scrambler therapy may be effective for the treatment of CIPN: a prospective placebo-controlled clinical trial should be performed.

Fig. 1

Daily CIPN scores (numbness, tingling, and pain) over 10 days of treatment. Reported scores refer to the average pain over the previous 24 h (1a). In Fig. 1b, current pain scores are illustrated just prior to and just after each daily treatment

Fig. 2

CIPN scores daily during treatment as well as during 10-week follow-up. The numbness, tingling, or pain combined group includes the total study population. Individual determinations of pain, numbness, or tingling involved the total study population during the daily treatments, but, during the follow-up weeks, only involved the last 14 patients, when a protocol modification was made to include these measures

Fig. 3

CIPN scores (for the combination of numbness, tingling, or pain) daily during treatment as well as during 10 week follow-up separated by earlier and later cohorts, defined by the time that the individual symptom questions were added to the protocol (a) and then further separated chronologically into four quartile groups (b)

Fig. 4

Global impression of change score for neuropathy symptoms daily during treatment as well as during the 10 week follow-up