PainOCTTTNCT03475082
Overcoming Analgesic Tolerance to TENS
A study testing Transcutaneous Electrical Nerve Stimulation in people with Pain, run by Kathleen Sluka.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 Years of Age (YOA)
- no current pain condition
Who cannot join
- Pregnancy
- Cardiac pacemaker
- Currently experiencing pain
- Abnormal sensation in dominant forearm
- History of seizures
- Prior TENS use
About this study
Official title: Use of Modulating Frequency or Increasing Intensity to Overcome Analgesic Tolerance to Transcutaneous Electrical Nerve Stimulation (TENS) in Healthy Adults
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Transcutaneous Electrical Nerve Stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationDevice
Also called TENS, Electrical stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre TENS and post TENS at initial (day 1) and final (day 5) study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study startJul 2012
- Primary completionDec 2019
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial -double blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathleen Sluka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathleen Sluka, University of Iowa
- Investigators
- Kathleen A Sluka, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475082
- Sponsor's protocol ID
- 201203735
- Acronym
- OCTTT
- Status last verified
- Apr 2021
- First submitted
- 14 Mar 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12620611Desantana 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.
PubMed 18374009Liebano 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.
PubMed 21144659
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Modulating Frequency or Increasing Intensity to Overcome Analgesic Tolerance to Transcutaneous Electrical Nerve Stimulation (TENS) in Healthy Adults
- ClinicalTrials.gov ID
- NCT03475082
- Acronym / sponsor ID
- OCTTT / 201203735
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kathleen SlukaUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- Randomized controlled trial -double blind
| Arm | Type | Receives |
|---|---|---|
| Placebo TENS | Placebo comparator | Device: Transcutaneous Electrical Nerve Stimulation30 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. |
| High Frequency TENS | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation30 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. |
| Alternating frequency TENS | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation30 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. |
| Modulated frequency TENS | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation30 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. |
| High frequency TENS - increasing intensity | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation30 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 Years of Age (YOA)
- no current pain condition
Key exclusion criteria (6 listed)
- Pregnancy
- Cardiac pacemaker
- Currently experiencing pain
- Abnormal sensation in dominant forearm
- History of seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationAlso: TENS, Electrical stimulationTranscutaneous 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. | Device | Alternating frequency TENS, High Frequency TENS, High frequency TENS - increasing intensity, Modulated frequency TENS, Placebo TENS |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Background: PubMed 12620611Chandran 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.
- Background: PubMed 18374009Desantana 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.
- Background: PubMed 21144659Liebano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen A Sluka, PhD principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation in people with Pain, run by Kathleen Sluka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (time frame: Pre TENS and post TENS at initial (day 1) and final (day 5) study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03475082, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.