NCT01194466 · ADVERSE EVENTS

Adverse events

Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC) · Source last updated 2019-09-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Active TENS Active high frequency TENS will be use for Active TENS. Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).	0 / 41	0 / 41	Not reported / Not reported
Low Intensity TENS Low Intensity TENS will be applied for one arm of the study Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).	0 / 41	0 / 41	Not reported / Not reported
No Treatment TENS unit in place but not turned on Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).	0 / 41	0 / 41	Not reported / Not reported

Group identifiers: EG000: Active TENS · EG001: Low Intensity TENS · EG002: No Treatment

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

event Groups

description
Active high frequency TENS will be use for Active TENS. Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).
id
EG000
other Num Affected
0
other Num At Risk
41
serious Num Affected
0
serious Num At Risk
41
title
Active TENS
description
Low Intensity TENS will be applied for one arm of the study Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).
id
EG001
other Num Affected
0
other Num At Risk
41
serious Num Affected
0
serious Num At Risk
41
title
Low Intensity TENS
description
TENS unit in place but not turned on Transcutaneous Electrical Nerve Stimulation (TENS): Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).
id
EG002
other Num Affected
0
other Num At Risk
41
serious Num Affected
0
serious Num At Risk
41
title
No Treatment

frequency Threshold

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Preserved source evidence · Not medical advice