Participant flow

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.

groups

1. description

   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

   id

   FG000

   title

   Order: Active, Placebo, No TENS

2. description

   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

   id

   FG001

   title

   Order: Placebo, Active, No TENS

3. description

   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

   id

   FG002

   title

   Order: No TENS, Active, Placebo

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         13

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         13

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

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.

recruitment Details

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)

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice