Overcoming Analgesic Tolerance to TENS

NCT03475082 | Completed

• 1 other identifier: 201203735
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pressure Pain Threshold

  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.

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

Study Arms (5)

Placebo TENS

PLACEBO COMPARATOR

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.

Device: Transcutaneous Electrical Nerve Stimulation

High Frequency TENS

ACTIVE COMPARATOR

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.

Device: Transcutaneous Electrical Nerve Stimulation

Alternating frequency TENS

ACTIVE COMPARATOR

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.

Device: Transcutaneous Electrical Nerve Stimulation

Modulated frequency TENS

ACTIVE COMPARATOR

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.

Device: Transcutaneous Electrical Nerve Stimulation

High frequency TENS - increasing intensity

ACTIVE COMPARATOR

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.

Device: Transcutaneous Electrical Nerve Stimulation

Interventions

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.

Also known as: TENS, Electrical stimulation

Alternating frequency TENS; High Frequency TENS; High frequency TENS - increasing intensity; Modulated frequency TENS; Placebo TENS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years of Age (YOA)
• no current pain condition

You may not qualify if:

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

Sponsors & Collaborators

• Kathleen Sluka: lead

Related Publications (3)

• Chandran P, Sluka KA. Development of opioid tolerance with repeated transcutaneous electrical nerve stimulation administration. Pain. 2003 Mar;102(1-2):195-201. doi: 10.1016/s0304-3959(02)00381-0.

  PMID: 12620611 BACKGROUND

• Desantana JM, Santana-Filho VJ, Sluka KA. Modulation between high- and low-frequency transcutaneous electric nerve stimulation delays the development of analgesic tolerance in arthritic rats. Arch Phys Med Rehabil. 2008 Apr;89(4):754-60. doi: 10.1016/j.apmr.2007.11.027.

  PMID: 18374009 BACKGROUND

• Liebano RE, Rakel B, Vance CGT, Walsh DM, Sluka KA. An investigation of the development of analgesic tolerance to TENS in humans. Pain. 2011 Feb;152(2):335-342. doi: 10.1016/j.pain.2010.10.040. Epub 2010 Dec 8.

  PMID: 21144659 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation; Electric Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Physical Stimulation; Investigative Techniques

Study Officials

• Kathleen A Sluka, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PT, PhD

Model Details: Randomized controlled trial -double blind

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 23, 2018
• Study Start: July 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share