Overcoming Analgesic Tolerance to TENS (OCTTT)

Kathleen Sluka

Status: Completed

Conditions: Pain

Treatments: Device: Transcutaneous Electrical Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03475082

201203735

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 5 patient groups, including a placebo group

Placebo TENS

Placebo Comparator group

Description:

30 minute TENS treatment where the stimulation ramps slowly to zero after 45 seconds. The lights/display on the unit are identical to the Active unit.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

High Frequency TENS

Active Comparator group

Description:

30 minute TENS treatment at 100 Hertz (HZ). Intensity set at a strong but comfortable setting and subject asked to increase intensity as tolerated every 5 minutes. Final stimulation intensity at end of Day 1 treatment used for the remainder of the treatment sessions for all 5 days.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

Alternating frequency TENS

Active Comparator group

Description:

30 minute TENS treatment with a pre programed mode alternating from 4 Hz and 100 HZ. Intensity set at a strong but comfortable setting and subject asked to increase intensity as tolerated every 5 minutes. Final stimulation intensity at end of Day 1 treatment used for the remainder of the treatment sessions for all 5 days.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

Modulated frequency TENS

Active Comparator group

Description:

30 minute TENS treatment at a pre programmed mode that ramps between 4 and 125 HZ over 12 seconds. Intensity set at a strong but comfortable setting and subject asked to increase intensity as tolerated every 5 minutes. Final stimulation intensity at end of Day 1 treatment used for the remainder of the treatment sessions for all 5 days.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation

High frequency TENS - increasing intensity

Active Comparator group

Description:

30 minute TENS treatment at 100 HZ. Intensity set at initial strong but comfortable setting on day one as above, then subjects asked for possible increases in intensity every 5 minutes on all five days.

Treatment:

Device: Transcutaneous Electrical Nerve Stimulation