Home-based high tone therapy may alleviate chemotherapy-induced neuropathic symptoms in patients with colorectal cancer: A randomized double-blind placebo-controlled pilot evaluation.

BACKGROUND: Most oncologic patients receiving chemotherapy suffer from neuropathy, which not only severely affects quality of life but also may lead to chemotherapy dose reductions or even discontinuation of cancer therapy. Still, it is difficult to sufficiently control these symptoms with the currently available pharmacological treatments. High tone therapy was reported to be an effective option for neuropathies due to different etiologies. However, to date, there are no studies on high tone therapy in patients with chemotherapy-induced peripheral neuropathy. METHODS: This randomized, double-blind, and placebo-controlled two-center study was conducted at the Departments of Physical and Rehabilitation Medicine at the Clinics Donaustadt and Ottakring, Vienna, Austria. Patients with histologically verified colorectal carcinoma treated with a platin derivate and neuropathic symptoms were invited to participate. High tone therapy took place in a home-based setting using the HiToP 191 PNP ® or placebo device for three weeks. Neuropathic symptoms and quality of life were assessed via questionnaires. After the follow-up examination, an opt-in was offered to the patients in the placebo group in terms of an open-label treatment with a verum HiToP PNP ® device. In addition, patients with chemotherapy-induced peripheral neuropathy due to various malignant diseases were treated in an open-label setting reflecting a clinical application observation. These patients are reported as a separate group. RESULTS: In the verum group, there was a significant reduction of paresthesias and mental stress due to paresthesias from baseline until end of therapy, compared to placebo. These findings were observed in the opt-in subgroup, as well. In the open-label clinical application observation group, intensity and mental stress due to paresthesia, pain, cramps, and intensity of tightness/pressure were significantly lower at the end of therapy, compared to baseline. CONCLUSIONS: Home-based high tone therapy brought about a significant alleviation in paresthesias and mental stress due to paresthesias in the verum but not the placebo group. In the clinical application observation, a significant alleviation in several further neuropathic symptoms was seen. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov (NCT06048471, 03/02/2020).

Associations between Patient-Reported and Clinician-Reported Outcome Measures in Patients after Traumatic Injuries of the Lower Limb.

Both clinician-reported outcome measures (CROMs) measures and patient-reported outcome measures (PROMs) are applied to evaluate outcomes in rehabilitation settings. The previous data show only a low to moderate correlation between these measures. Relationships between functional performance measures (Clinician-Reported Outcome Measures, CROMs) and Patient-Reported Outcome Measures (PROMs) were analysed in rehabilitation patients with traumatic injuries of the lower limb. A cohort of 315 patients with 3 subgroups (127 hip, 101 knee and 87 ankle region) was analysed before and after 3 weeks of inpatient rehabilitation. All three groups showed significant improvements in PROMs with low to moderate effect sizes. Moderate to high effect sizes were found for CROMs. Correlation coefficients between CROMs and PROMs were low to moderate. The performance consistency between PROMs and CROMs ranged from 56.7% to 64.1%. In this cohort of rehabilitation patients with traumatic injuries, CROMs showed higher effect sizes than PROMs. When used in combination, patient-reported outcome and performance measures contribute to collecting complementary information, enabling the practitioner to make a more accurate clinical evaluation of the patient's condition.