Transcutaneous Electrical Nerve StimulationTENSNCT01999595

The Antalgic Effect of Pulse Frequency and Pad Size of TENS on Blunt Pressure Pain

A study testing High frequency TENS with large pads, Low frequency TENS with large pads and High frequency TENS with small pads in people with Transcutaneous Electrical Nerve Stimulation and Blunt Pressure Pain, run by Chang Gung University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the antalgic of surface electrical stimulation with pulse frequencies and pad sizes on blunting pressure pain on healthy human due to various temporal and spatial summations of the stimulation. Read more about this study

Who is it for?: Ages 18 to 26 yearsHealthy volunteers can take part
Conditions the study is for: Transcutaneous Electrical Nerve Stimulation, Blunt Pressure Pain, Pad Size
What is being tested?: High frequency TENS with large pads, Low frequency TENS with large pads and High frequency TENS with small pads
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteTaiwan
Study dates: 1 Mar 2010to 30 May 2013
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 26 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy and aged 18 years or over

Who cannot join

Any open wound around the arm or hand area, including edema or inflammation;
Cardiac or vascular problems (such as coronary artery disease, coronary thrombosis, or angina pain, high blood pressures, phlebitis, and pacemaker implantation);
Any dermatological problems or infections around the hand, forearm, or arm area (such as dermatitis or eczema, bacterial or fungal infections);
Any history of neoplasm or malignancy;
Bleeding diseases on the arm or hand (such as haemorrhage); Menstruation or pregnancy;
Abnormal neurological signs in the upper limbs (such as altered skin sensations);
Hypersensitivity or phobia to electrical application;
Any current medication regime.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Chang Gung University
Guishan, Taoyuan, 33302

Other trials in Taiwan

About this study

Official title: The Effect of Pulse Frequency and Pad Size of Transcutaneous Electrical Nerve Stimulation (TENS) on Experimental Blunt Pressure Pain in Healthy Participants

Read the detailed description

Potential participants expressing interest in the study will be given to read the contraindications for the pain tests and the stimulation intervention, which has been documented on the consent form. All participants meeting entry requirements will be invited to participate in the experiments which take place on a separate occasion.

Each participant will sign the consent form and will be told again that they can withdraw from the study at any time and without explanation. Each participant will be required to experience a 10-minute pre-stimulation period, a 30 minute TENS intervention, a 30 minute follow-up period.

Participants will be seated on a chair with arm support provided by a side table. The investigator will be then informed the stimulation intervention and used pad size on the stimulation periods in written form contained in a sealed envelope. After the participant's verbal permission is obtained, the investigator will apply the pads on the dorsal forearm area.

Either the large size pad, 5cm x 10cm, or the small size,2.5cm x 2.5cm, will be choose to place on the dorsal side of the forearm to straddle the site for blunt pressure pain. The muscle bellies of the forearm are mainly located on the proximal half part. The proximal pad will be attached to the lateral epi-condyle of the elbow, and the distal electrode will be placed 3cm distal to the proximal one along the line between the lateral part of elbow and the mid-point of the wrist. The pads will be then connected to the intervention stimulator. The investigator will relay instructions to the participants using cue cards displayed 30 seconds before any required action.

Before each blunting pressure pain test, the participant will sit comfortably and place their right upper extremity on a side table with the shoulder abduction, elbow flexion, the forearm pronation. The test will be induced using a pressure algometer with a flat circular probe, measuring 1.1cm in diameter (1cm2 on skin surface). Force will be displayed digitally in increments of 0.1 Newton. The algometer will be applied to the mid-point between the intervention pads. The rate of the pressure algometer application will be around 6 Newtons per second on average. The participants will be asked to concentrate on the sensations in the forearm. When the pressure becomes definitely painful, the participant will state "Pain!" and the force will be stopped. The pain threshold will be taken twice in a minute for one test and each measurement will take no more than 30 seconds.

There will be seven 1-minute tests performed in this experiment. The first test in pre-stimulation period. The second and third tests were administered and started at 9, 19, 29 minute time points in the stimulation-on period. A 30 minute post stimulation period will be then followed. Another 3 tests will be performed in this period in ten-minute intervals at 39, 49, 59 minute time points after the stimulation start.

Conditions: Transcutaneous Electrical Nerve Stimulation, Blunt Pressure Pain, Pad Size, Pulse Frequency, Analgesia
Being tested: Control TENS, Sham TENS, High frequency TENS with large pads, Low frequency TENS with large pads, High frequency TENS with small pads
Keywords: transcutaneous electrical nerve stimulation, pad size, pulse frequency, blunt pressure pain, healthy humans.
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Control TENSDevice
Control TENS was the application of electrical stimulation via skin with no current
Sham TENSDevice
Sham TENS was the application of electrical stimulation via skin with no current on the participant, who was told "TENS is at a turn-on level whether or not you feel it"
High frequency TENS with large padsDevice
High frequency TENS was delivered on large electrodes
Low frequency TENS with large padsDevice
Low frequency TENS was delivered on large electrodes
High frequency TENS with small padsDevice
High frequency TENS was delivered on small electrodes
Low frequency TENS with small padsDevice
Low frequency TENS was delivered on small electrodes

Study groups in NCT01999595
Study group	Role	What they receive
High frequency TENS with large pads	Experimental	TENS=transcutaneous electrical nerve stimulation High frequency TENS was a 80 Hz TENS delivered via a pair of electrodes with the size of 5 cm x 10 cm Dosage: same as electrical density using a standardized pad size (5cm x 5cm) with comfortable intensity Receives: Device: High frequency TENS with large pads
Low frequency TENS with large pads	Experimental	TENS=transcutaneous electrical nerve stimulation Low frequency TENS was a 3 Hz TENS delivered via a pair of electrodes with the size of 5 cm x 10 cm Dosage: same as electrical density using a standardized pad size (5cm x 5cm) with comfortable intensity Receives: Device: Low frequency TENS with large pads
High frequency TENS with small pads	Experimental	TENS=transcutaneous electrical nerve stimulation High frequency TENS was a 80 Hz TENS delivered via a pair of electrodes with the size of 5 cm x 2.5 cm Dosage: same as electrical density using a standardized pad size (5cm x 5cm) with comfortable intensity Receives: Device: High frequency TENS with small pads
Low frequency TENS with small pads	Experimental	TENS=transcutaneous electrical nerve stimulation Low frequency TENS was a 3 Hz TENS delivered via a pair of electrodes with the size of 5 cm x 2.5 cm Dosage: same as electrical density using a standardized pad size (5cm x 5cm) with comfortable intensity Receives: Device: Low frequency TENS with small pads
Control TENS	Placebo comparator	TENS=transcutaneous electrical nerve stimulation Control TENS was the application of electrical stimulation via skin with no current Receives: Device: Control TENS
Sham TENS	Sham comparator	TENS=transcutaneous electrical nerve stimulation Sham TENS was the application of electrical stimulation via skin with no current on the participant, who was told that the TENS was "turn-on" whether you feel it or not Receives: Device: Sham TENS

What is being measured

The primary outcome is the main question the study is designed to answer.

blunting pressure pain threshold
The test will be induced using a pressure algometer with a flat circular probe, measuring 1.1cm in diameter (1cm2 on skin surface). Force will be displayed digitally in increments of 0.1 Newton. The algometer will be applied to the mid-point between the electrodes. The rate of the pressure algometer application will be around 6 Newtons per second on average. The participants will be asked to concentrate on the sensations in the forearm. When the pressure becomes definitely painful, the participant will state "Pain!" to stop the pressure force.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 201030 May 2013

First posted3 Dec 2013 (estimated)
Study start1 Mar 2010
Primary completion30 May 2013
Study completion30 May 2013

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 Transcutaneous Electrical Nerve StimulationStudies 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: One hundred eighty participants (equal number of females and males, Fig. 1) were randomly assigned into six groups with the following TENS characteristics. (1) Group 1: control group, (2) group 2: sham group, (3) group 3: high frequency (80 pps)/large pad (5 cm x 10 cm) group, (4) group 4: low frequency (3 pps)/large pad (5 cm x 10 cm) group, (5) group 5: high frequency (80 pps)/small pad (5 cm x 2.5 cm) group, and (6) group 6: low frequency (3 pps)/small pad (5 cm x 2.5 cm) group.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01999595
Sponsor's protocol ID: 102-4765B
Other IDs: HK-99-B-07
Acronym: TENS
Status last verified: Dec 2021
First submitted: 26 Nov 2013
Last updated: 22 Dec 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chesterton LS, Foster NE, Wright CC, Baxter GD, Barlas P. Effects of TENS frequency, intensity and stimulation site parameter manipulation on pressure pain thresholds in healthy human subjects. Pain. 2003 Nov;106(1-2):73-80. doi: 10.1016/s0304-3959(03)00292-6.
PubMed 14581113
Chesterton LS, Barlas P, Foster NE, Baxter DG, Wright CC. Gender differences in pressure pain threshold in healthy humans. Pain. 2003 Feb;101(3):259-266. doi: 10.1016/S0304-3959(02)00330-5.
PubMed 12583868
Chesterton LS, Barlas P, Foster NE, Lundeberg T, Wright CC, Baxter GD. Sensory stimulation (TENS): effects of parameter manipulation on mechanical pain thresholds in healthy human subjects. Pain. 2002 Sep;99(1-2):253-62. doi: 10.1016/s0304-3959(02)00118-5.
PubMed 12237203

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
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Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception
Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee

All Transcutaneous Electrical Nerve Stimulation trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Pulse Frequency and Pad Size of Transcutaneous Electrical Nerve Stimulation (TENS) on Experimental Blunt Pressure Pain in Healthy Participants
ClinicalTrials.gov ID: NCT01999595
Acronym / sponsor ID: TENS / 102-4765B
Conditions: Transcutaneous Electrical Nerve Stimulation, Blunt Pressure Pain, Pad Size, Pulse Frequency, Analgesia
Keywords: transcutaneous electrical nerve stimulation, pad size, pulse frequency, blunt pressure pain, healthy humans.
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Chang Gung UniversityUniversity, hospital or other
Collaborators: Hung Kaung University
Study start: 1 Mar 2010 (actual)
Primary completion: 30 May 2013 (actual)
Study completion: 30 May 2013 (actual)
First posted: 3 Dec 2013 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6
Model description: One hundred eighty participants (equal number of females and males, Fig. 1) were randomly assigned into six groups with the following TENS characteristics. (1) Group 1: control group, (2) group 2: sham group, (3) group 3: high frequency (80 pps)/large pad (5 cm x 10 cm) group, (4) group 4: low frequency (3 pps)/large pad (5 cm x 10 cm) group, (5) group 5: high frequency (80 pps)/small pad (5 cm x 2.5 cm) group, and (6) group 6: low frequency (3 pps)/small pad (5 cm x 2.5 cm) group.

Arm	Type	Receives
High frequency TENS with large pads	Experimental	Device: High frequency TENS with large padsTENS=transcutaneous electrical nerve stimulation High frequency TENS was a 80 Hz TENS delivered via a pair of electrodes with the size of 5 cm x 10 cm Dosage: same as electrical density using a standardized pad size (5cm x 5cm) with comfortable intensity
Low frequency TENS with large pads	Experimental	Device: Low frequency TENS with large padsTENS=transcutaneous electrical nerve stimulation Low frequency TENS was a 3 Hz TENS delivered via a pair of electrodes with the size of 5 cm x 10 cm Dosage: same as electrical density using a standardized pad size (5cm x 5cm) with comfortable intensity
High frequency TENS with small pads	Experimental	Device: High frequency TENS with small padsTENS=transcutaneous electrical nerve stimulation High frequency TENS was a 80 Hz TENS delivered via a pair of electrodes with the size of 5 cm x 2.5 cm Dosage: same as electrical density using a standardized pad size (5cm x 5cm) with comfortable intensity
Low frequency TENS with small pads	Experimental	Device: Low frequency TENS with small padsTENS=transcutaneous electrical nerve stimulation Low frequency TENS was a 3 Hz TENS delivered via a pair of electrodes with the size of 5 cm x 2.5 cm Dosage: same as electrical density using a standardized pad size (5cm x 5cm) with comfortable intensity
Control TENS	Placebo comparator	Device: Control TENSTENS=transcutaneous electrical nerve stimulation Control TENS was the application of electrical stimulation via skin with no current
Sham TENS	Sham comparator	Device: Sham TENSTENS=transcutaneous electrical nerve stimulation Sham TENS was the application of electrical stimulation via skin with no current on the participant, who was told that the TENS was "turn-on" whether you feel it or not

Who may qualify

Ages: 18 to 26 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy and aged 18 years or over

Key exclusion criteria (8 listed)

Any open wound around the arm or hand area, including edema or inflammation;
Cardiac or vascular problems (such as coronary artery disease, coronary thrombosis, or angina pain, high blood pressures, phlebitis, and pacemaker implantation);
Any dermatological problems or infections around the hand, forearm, or arm area (such as dermatitis or eczema, bacterial or fungal infections);
Any history of neoplasm or malignancy;
Bleeding diseases on the arm or hand (such as haemorrhage); Menstruation or pregnancy;

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
Control TENSControl TENS was the application of electrical stimulation via skin with no current	Device	Control TENS
Sham TENSSham TENS was the application of electrical stimulation via skin with no current on the participant, who was told "TENS is at a turn-on level whether or not you feel it"	Device	Sham TENS
High frequency TENS with large padsHigh frequency TENS was delivered on large electrodes	Device	High frequency TENS with large pads
Low frequency TENS with large padsLow frequency TENS was delivered on large electrodes	Device	Low frequency TENS with large pads
High frequency TENS with small padsHigh frequency TENS was delivered on small electrodes	Device	High frequency TENS with small pads
Low frequency TENS with small padsLow frequency TENS was delivered on small electrodes	Device	Low frequency TENS with small pads

Primary outcome

blunting pressure pain threshold
Time frame: 6 months
The test will be induced using a pressure algometer with a flat circular probe, measuring 1.1cm in diameter (1cm2 on skin surface). Force will be displayed digitally in increments of 0.1 Newton. The algometer will be applied to the mid-point between the electrodes. The rate of the pressure algometer application will be around 6 Newtons per second on average. The participants will be asked to concentrate on the sensations in the forearm. When the pressure becomes definitely painful, the participant will state "Pain!" to stop the pressure force.

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 22 Dec 2021.
Results publication: PubMed 14581113Chesterton LS, Foster NE, Wright CC, Baxter GD, Barlas P. Effects of TENS frequency, intensity and stimulation site parameter manipulation on pressure pain thresholds in healthy human subjects. Pain. 2003 Nov;106(1-2):73-80. doi: 10.1016/s0304-3959(03)00292-6.
Results publication: PubMed 12583868Chesterton LS, Barlas P, Foster NE, Baxter DG, Wright CC. Gender differences in pressure pain threshold in healthy humans. Pain. 2003 Feb;101(3):259-266. doi: 10.1016/S0304-3959(02)00330-5.
Results publication: PubMed 12237203Chesterton LS, Barlas P, Foster NE, Lundeberg T, Wright CC, Baxter GD. Sensory stimulation (TENS): effects of parameter manipulation on mechanical pain thresholds in healthy human subjects. Pain. 2002 Sep;99(1-2):253-62. doi: 10.1016/s0304-3959(02)00118-5.
Individual participant dataSharing planned: No

Related trials for Transcutaneous Electrical Nerve Stimulation

Recruiting
Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury
Spinal Cord Injury, Acute
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Parasacral TENS Project
Overactive Bladder (OAB), Lower Urinary Tract Dysfunction
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
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Recruiting
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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.

Chih Chung Chen, D.Ph. principal investigator

Chang Gung University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 8 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 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

blunting pressure pain threshold (time frame: 6 months). 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 NCT01999595, 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 22 Dec 2021.