Overcoming Analgesic Tolerance to TENS | Clinical Trial

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18-65 Years of Age (YOA)
no current pain condition

Exclusion criteria

Pregnancy
Cardiac pacemaker
Currently experiencing pain
Abnormal sensation in dominant forearm
History of seizures
Prior TENS use

Treatment and study plan

Transcutaneous electrical nerve stimulation

Device

Transcutaneous electrical nerve stimulation (TENS) is utilized clinically by a variety of health care professionals for the reduction of pain. The mechanisms by which TENS produces analgesia or reduces pain are only recently being elucidated. TENS is a non-invasive modality that is inexpensive, safe and easy to use with relatively few contraindications. Frequency of stimulation is broadly classified as high frequency (>50Hz), low frequency (<10Hz) TENS. Intensity is determined by the response of the patient as either sensory level (low-intensity) TENS strong but comfortable. With sensory level TENS, the voltage (i.e. amplitude) is increased only until the patient feels a comfortable tingling (perceived with high frequency) or tapping (perceived with low frequency) sensation without motor contraction. With strong but comfortable TENS the intensity is increased to a strong but comfortable level which may include muscle contraction.

Other names: TENS, Electrical stimulation

Primary outcomes

Pressure Pain Threshold

Time frame: Pre TENS and post TENS at initial (day 1) and final (day 5) study visit

Pressure pain thresholds (PPTs) change score measured in kilopascal (kPa) will be assessed on the forearm using a pressure algometer. The pressure algometer is mechanical pressure applied by the research assistant at a gradual rate by pushing the device against the skin. The device has a 1 cm2 pad that is in contact with the skin. The subject has a button that they push when the pressure first becomes painful (threshold)which stops the test and the pressure amount is recorded by the research assistant. This is the amount of pressured in kPa that is required to cause a subjective pain of 1/10 on a scale of 0 (no Pain) to 10 (Maximum Pain) rating by the subject. The change score from day 1 to Day 5 is the primary outcome measure.

Sponsors and collaborators

Lead sponsor

Kathleen Sluka

Other

Registry information

Official study title

Use of Modulating Frequency or Increasing Intensity to Overcome Analgesic Tolerance to Transcutaneous Electrical Nerve Stimulation (TENS) in Healthy Adults

Acronym: OCTTT

Important dates

Study start: 2012
Primary completion: 2019
Study completion: 2021
First posted: Mar 23, 2018
Registry last updated: Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed