- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01999595
The Antalgic Effect of Pulse Frequency and Pad Size of TENS on Blunt Pressure Pain (TENS)
The Effect of Pulse Frequency and Pad Size of Transcutaneous Electrical Nerve Stimulation (TENS) on Experimental Blunt Pressure Pain in Healthy Participants
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taoyuan
-
Guishan, Taoyuan, Taiwan, 33302
- Chang Gung University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy and aged 18 years or over
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High frequency TENS with large pads
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 |
High frequency TENS was delivered on large electrodes
|
EXPERIMENTAL: Low frequency TENS with large pads
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 |
Low frequency TENS was delivered on large electrodes
|
EXPERIMENTAL: High frequency TENS with small pads
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 |
High frequency TENS was delivered on small electrodes
|
EXPERIMENTAL: Low frequency TENS with small pads
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 |
Low frequency TENS was delivered on small electrodes
|
PLACEBO_COMPARATOR: Control TENS
TENS=transcutaneous electrical nerve stimulation Control TENS was the application of electrical stimulation via skin with no current |
Control TENS was the application of electrical stimulation via skin with no current
|
SHAM_COMPARATOR: Sham TENS
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 |
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"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chih Chung Chen, D.Ph., Chang Gung University
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 102-4765B
- HK-99-B-07 (OTHER: Hung Kuang University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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