Clinical trial NCT01999595: The Antalgic Effect of Pulse Frequency and Pad Size of TENS on Blunt Pressure Pain
Official title: The Effect of Pulse Frequency and Pad Size of Transcutaneous Electrical Nerve Stimulation (TENS) on Experimental Blunt Pressure Pain in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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.
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: Hung Kaung University
First posted: 2013-12-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: blunting pressure pain threshold
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guishan
country: Taiwan
facility: Chang Gung University
state: Taoyuan
Study officials:
affiliation: Chang Gung University
name: Chih Chung Chen, D.Ph.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.