Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC) (NCT NCT01194466)

NCT ID: NCT01194466

Last Updated: 2019-09-17

Results Overview

Participants rated 0-10 pain intensity in head/neck cancer area using one number (where their disease was located) by a vertical line on a horizontal 10-cm visual analog scale (VAS) from 0 "no pain" to 10 "worst possible pain." Possible scores ranged from 0-10 (10=worse pain). VAS was assessed two times each visit: (1) Pre-VAS: start of visit, (2) Post-VAS: end of the visit. The outcome measure was each person's change in pain: Pre-VAS minus Post-VAS, to create VAS change score. An average of all participants' VAS change score was calculated for each TENS condition (Active, Placebo, No TENS) and used as the dependent measure.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions

Results posted on

2019-09-17

Participant Flow

This prospective, randomized, double-blinded, and placebo controlled study was conducted between May 2011 and August 2012 at the University of Iowa Hospitals and Clinics (Clinical-Trials.gov identifier, NCT01194466)

Study exclusion criteria were (1) TENS use within 5 years, (2) conditions precluding TENS use (pacemaker, nickel allergy), (3) pain intensity less than 1 of 10 with rest or swallowing, (4) sensory impairment (could not identify sharp and dull stimuli on face), and/or (5) inability to read, write, or follow directions.

Participant milestones

Participant milestones
Measure	Order: Active, Placebo, No TENS Active high frequency TENS will be used visit 1 Washout 6 days Placebo for visit 2- 7 days after visit 1 Washout for 6 days No tens visit 3- 7 days after visit 2	Order: Placebo, Active, No TENS Placebo low frequency TENS will be used visit 1 Washout 6 days Active high intensity TENS for visit 2- 7 days after visit 1 Washout for 6 days No tens visit 3- 7 days after visit 2	Order: No TENS, Active, Placebo No TENS will be used visit 1 Washout 6 days Active high intensity TENS for visit 2- 7 days after visit 1 Washout for 6 days Placebo Low Intensity TENS visit 3- 7 days after visit 2
Overall Study STARTED	14	14	13
Overall Study COMPLETED	14	14	13
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcutaneous Electrical Nerve Stimulation (TENS) and Head and Neck Cancer Pain (HNC) (TENS & HNC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=41 Participants All participants' characteristics, prior to first treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants

PRIMARY outcome

Timeframe: The change in VAS pain score was assessed within one study visit for each of the 3 study TENS conditions

Population: The sample was adults (18 or greater) years old with oropharyngeal or laryngeal cancer.

Outcome measures

Outcome measures
Measure	Active TENS n=40 Participants Each participant received an Active TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Active TENS condition. Active TENS was delivered for 30 minutes at a frequency of 125Hz and a pulse duration of 100 2s on continuous mode output (calibrated using an oscilloscope before the study). Transcutaneous electrical nerve stimulation intensity was increased by the allocator until patients reported a ''maximally strong but comfortable sensation'' to ensure an analgesic effect.	Placebo TENS n=40 Participants Each participant received an Placebo TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the Placebo TENS condition. Placebo TENS parameters were identical to active TENS (125 Hz, 100 2s). A novel, transient placebo TENS unit, previously tested and validated, was used. The intensity was increased until patients first felt ''any sensation at all (sensory threshold)'' in any electrode (ie, they did not have to reach sensory threshold in all electrodes). The placebo device then provided a current for 30 seconds and decreased gradually over 15 seconds to 0 output (ie, 45 seconds from the first sensory threshold). An indicator light remained on for the remainder of the visit so it appeared to the participant and outcomes assessor that the unit was still producing current.	No TENS n=40 Participants Each participant received a No TENS intervention at one clinic visit, separated approximately one week from the other 2 TENS condition visits. In other words, all participants received the No TENS condition. No TENS parameters were identical to active and placebo TENS, except that (1) the unit was never turned on and (2) participants were told that the unit was not on.
Change in Pain Intensity in Head/Neck Cancer Area: 10cm Visual Analog Scale (VAS)	-1.4 change units on a VAS scale Standard Deviation 1.3	-0.6 change units on a VAS scale Standard Deviation 1.1	0.1 change units on a VAS scale Standard Deviation 0.9

Adverse Events

Active TENS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Intensity TENS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jen Lee

Mount Mercy University/The University of Iowa

Phone: 3193231623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place