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

NCT01999595 | Completed DMC

• 2 other identifiers: 102-4765BHK-99-B-07
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

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.

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (6)

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

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

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

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

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

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

Device: Sham TENS

Interventions

Control TENS DEVICE

Control TENS was the application of electrical stimulation via skin with no current

Control TENS

Sham TENS DEVICE

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"

Sham TENS

High frequency TENS with large pads DEVICE

High frequency TENS was delivered on large electrodes

High frequency TENS with large pads

Low frequency TENS with large pads DEVICE

Low frequency TENS was delivered on large electrodes

Low frequency TENS with large pads

High frequency TENS with small pads DEVICE

High frequency TENS was delivered on small electrodes

High frequency TENS with small pads

Low frequency TENS with small pads DEVICE

Low frequency TENS was delivered on small electrodes

Low frequency TENS with small pads

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy and aged 18 years or over

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung University: lead
• Hung Kaung University: collaborator

Study Sites (1)

Chang Gung University

Guishan, Taoyuan, 33302, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 14581113 RESULT

• 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.

  PMID: 12583868 RESULT

• 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.

  PMID: 12237203 RESULT

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chih Chung Chen, D.Ph.

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The group allocation for each participant was sealed in an envelope prepared by an investigator. Just before the start of the second visit, a second investigator opened the envelope to confirm the allocation of TENS groups for individual participants and applied the TENS. For better blinding, a third investigator assessed the blunt pressure pain threshold (BPPT) for the baseline value.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Department of Physical Therapy

Model Details: 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.

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: March 1, 2010
• Primary Completion: May 30, 2013
• Study Completion: May 30, 2013
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)