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

Not Applicable

Completed

• Conditions: Blunt Pressure Pain; Pad Size; Analgesia; Transcutaneous Electrical Nerve Stimulation; Pulse Frequency
• Interventions: Device: High frequency TENS with small pads; Device: Sham TENS; Device: High frequency TENS with large pads; Device: Low frequency TENS with large pads; Device: Control TENS; Device: Low frequency TENS with small pads

• Registration Number: NCT01999595
• Lead Sponsor: Chang Gung University

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.

Study Timeline

• Study Start: 2010-03-01
• Primary Completion: 2013-05-30
• Study Completion: 2013-05-30
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-03
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High frequency TENS with small pads	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
Sham TENS	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
High frequency TENS with large pads	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
Low frequency TENS with large pads	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
Control TENS	Control TENS	TENS=transcutaneous electrical nerve stimulation Control TENS was the application of electrical stimulation via skin with no current
Low frequency TENS with small pads	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

Primary Outcome Measures

Name	Time	Method
blunting pressure pain threshold	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.

Trial Locations

Locations (1)

Chang Gung University; 🇨🇳 Guishan, Taoyuan, Taiwan