The Antalgic Effect of Pulse Frequency and Pad Size of TENS on Blunt Pressure Pain
NCT ID: NCT01999595
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2010-03-01
2013-05-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
DOUBLE
Study Groups
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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 with large pads
High frequency TENS was delivered on large electrodes
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 with large pads
Low frequency TENS was delivered on large electrodes
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 with small pads
High frequency TENS was delivered on small electrodes
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 with small pads
Low frequency TENS was delivered on small electrodes
Control TENS
TENS=transcutaneous electrical nerve stimulation
Control TENS was the application of electrical stimulation via skin with no current
Control TENS
Control TENS was the application of electrical stimulation via skin with no current
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
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"
Interventions
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Control TENS
Control TENS was the application of electrical stimulation via skin with no current
Sham TENS
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 pads
High frequency TENS was delivered on large electrodes
Low frequency TENS with large pads
Low frequency TENS was delivered on large electrodes
High frequency TENS with small pads
High frequency TENS was delivered on small electrodes
Low frequency TENS with small pads
Low frequency TENS was delivered on small electrodes
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
26 Years
ALL
Yes
Sponsors
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Hung Kaung University
OTHER
Chang Gung University
OTHER
Responsible Party
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Chih Chung Chen
Assistant Professor in Department of Physical Therapy
Principal Investigators
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Chih Chung Chen, D.Ph.
Role: PRINCIPAL_INVESTIGATOR
Chang Gung University
Locations
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Chang Gung University
Guishan, Taoyuan, Taiwan
Countries
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References
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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.
Other Identifiers
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HK-99-B-07
Identifier Type: OTHER
Identifier Source: secondary_id
102-4765B
Identifier Type: -
Identifier Source: org_study_id