Overcoming Analgesic Tolerance to TENS (OCTTT)
Use of Modulating Frequency or Increasing Intensity to Overcome Analgesic Tolerance to Transcutaneous Electrical Nerve Stimulation (TENS) in Healthy Adults
Sponsor: Kathleen Sluka
Listed as NCT03475082, this NA trial focuses on Pain and remains completed. Sponsored by Kathleen Sluka, it has been updated 9 times since 2012, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)Healthy adults will come daily for 5 consecutive days to the testing room. Pressure pain thresholds (PPT) will be the outcome measure and will be used to measure the subject's pain threshold to deep mechanical pressure. Subjects will push a button to stop the PPT test when they first begin to feel a sensation of pain. The PPT test will be done before TENS application. The TENS unit will be applied based on random assignment to 1 of 5 treatment types and subjects will not be told which group they are assigned to. Those groups are: 1) placebo TENS, 2) high frequency TENS, 3) alternating frequency TENS, 4) modulated frequency TENS, or 5) high frequency TENS with increased intensity daily. The TENS unit will be applied for 30 minutes. After 20 minutes the PPT test will be completed a second time. This procedure will occur on all 5 consecutive days of testing. Data will be measured and recorded by an assessor blind to subject group. Blinding will be assessed at the end of testing on day 5.
Healthy adults will come daily for 5 consecutive days to the testing room. Pressure pain thresholds (PPT) will be the outcome measure and will be used to measure the subject's pain threshold to deep mechanical pressure. Subjects will push a button to stop the PPT test when they first begin to feel a sensation of pain. The PPT test will be done before TENS application. The TENS unit will be applied based on random assignment to 1 of 5 treatment types and subjects will not be told which group they are assigned to. Those groups are: 1) placebo TENS, 2) high frequency TENS, 3) alternating frequency TENS, 4) modulated frequency TENS, or 5) high frequency TENS with increased intensity daily. The TENS unit will be applied for 30 minutes. After 20 minutes the PPT test will be completed a second time. This procedure will occur on all 5 consecutive days of testing. Data will be measured and recorded by an assessor blind to subject group. Blinding will be assessed at the end of testing on day 5.
Status Flow
Change History
9 versions recorded-
Sep 2024 — Present [monthly]
Completed NA
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Jul 2024 — Sep 2024 [monthly]
Completed NA
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May 2021 — Jul 2024 [monthly]
Completed NA
Status: Active Not Recruiting → Completed
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Jan 2021 — May 2021 [monthly]
Active Not Recruiting NA
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Feb 2020 — Jan 2021 [monthly]
Active Not Recruiting NA
▶ Show 4 earlier versions
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Mar 2019 — Feb 2020 [monthly]
Active Not Recruiting NA
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Oct 2018 — Mar 2019 [monthly]
Active Not Recruiting NA
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Jun 2018 — Oct 2018 [monthly]
Active Not Recruiting NA
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Apr 2018 — Jun 2018 [monthly]
Active Not Recruiting NA
First recorded
Jul 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Kathleen Sluka
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
No location information available.