Overcoming Analgesic Tolerance to TENS
- Conditions
- Pain
- Registration Number
- NCT03475082
- Lead Sponsor
- Kathleen Sluka
- Brief Summary
The purpose of this study is to determine if changing the frequency or intensity of transcutaneous electrical nerve stimulation (TENS) can reduce the development of tolerance to TENS treatment.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 18-65 Years of Age (YOA)
- no current pain condition
- Pregnancy
- Cardiac pacemaker
- Currently experiencing pain
- Abnormal sensation in dominant forearm
- History of seizures
- Prior TENS use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pressure Pain Threshold 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.
- Secondary Outcome Measures
Name Time Method