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Transcutaneous Electrical Nerve Stimulation for Orthodontic Pain

N/A

Waitlist Available

Research Sponsored by University of the Pacific

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients not currently taking any medications for pain management

Patients undergoing orthodontic treatment that requires the use of full-fixed appliances

Must not have

Patients taking any over-the-counter or prescription pain medication during the testing period.

Patients with a history of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pain will be measured at the following time points: immediately after appliance placement (0 hours), 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours post-placement.

Summary

This trial aims to see if using a special device called TENS can help reduce pain during orthodontic treatment in both young people and adults. The study will compare the pain levels between the side of

Who is the study for?

This trial is for adolescents and adults who are about to receive orthodontic appliances. Participants must be willing to report their pain levels at multiple times after the procedure. There's no specific mention of exclusion criteria, so general health requirements likely apply.

What is being tested?

The study tests if a TENS device can lessen pain during orthodontic treatment by comparing a working TENS on one side of the mouth with a placebo device on the other side. Each participant serves as their own control, ensuring direct comparison within individuals.

What are the potential side effects?

While not explicitly stated, typical side effects from using TENS may include skin irritation where the pads attach, tingling or prickling sensations during use, and muscle twitching. Most people tolerate it well.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not taking any pain medications.

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I am currently undergoing orthodontic treatment with braces.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking pain medication, either over-the-counter or prescribed.

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I have a history of seizures.

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I have or had heart rhythm problems or have a pacemaker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pain will be measured at the following time points: immediately after appliance placement (0 hours), 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours post-placement.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pain will be measured at the following time points: immediately after appliance placement (0 hours), 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours post-placement.

This trial's timeline: 3 weeks for screening, Varies for treatment, and pain will be measured at the following time points: immediately after appliance placement (0 hours), 2 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours post-placement. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Outcome Measure: Difference in Pain Levels Between Active TENS and Placebo

Secondary study objectives

Duration of Pain Relief

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Upper Right Side - Active TENS DeviceExperimental Treatment1 Intervention

Participants will receive the active TENS device on the upper right side of their mouth. This arm is designed to evaluate the effectiveness of the TENS device in reducing pain during orthodontic alignment on this specific side of the upper arch.

Group II: Arm 3: Lower Right Side - Active TENS DeviceExperimental Treatment1 Intervention

Participants will receive the active TENS device on the lower right side of their mouth. This arm is intended to assess the effectiveness of the TENS device in reducing pain during orthodontic alignment on this specific side of the lower arch.

Group III: Arm 4: Lower Left Side - Placebo/Sham DevicePlacebo Group1 Intervention

Participants will receive a placebo (non-functioning) device on the lower left side of their mouth. This arm also serves as a control, providing a basis for comparison with the side receiving the active TENS device.

Group IV: Arm 2: Upper Left Side - Placebo/Sham DevicePlacebo Group1 Intervention

Participants will receive a placebo (non-functioning) device on the upper left side of their mouth. This arm serves as a control to compare pain levels with the side receiving the active TENS device.

0 / 5Eligibility criteria met