Effects of TENS Therapy Following Arthroscopic Knee Surgery (TENS)

January 10, 2019 updated by: A.T. Still University of Health Sciences

Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Postoperative Pain and Function Following Arthroscopic Knee Surgery: A Prospective Randomized Clinical Trial Pilot Study

Following standard of care procedures for arthroscopy knee surgery it is anticipated that Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and improve functional outcomes.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Kirksville, Missouri, United States, 63501
        • North Missouri Sports Medicine and Orthopaedic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-60
  • BMI<50
  • No significant joint malalignment
  • No significant ligamentous instability
  • No significant radiographic joint space narrowing
  • No prior significant knee surgery
  • Unilateral knee surgery
  • Not workman's compensation
  • Planned knee arthroscopy for meniscectomy, chondroplasty or synovectomy

Exclusion Criteria:

  • Age <18 or >60
  • BMI > 50
  • Significant joint malalignment
  • Significant ligamentous instability
  • Significant radiographic joint space narrowing
  • Prior significant knee surgery
  • Bilateral knee surgery planned
  • Worker's Compensation
  • No planned knee arthroscopy for menisectomy, chondroplasty or synovectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Structured TENS Therapy
This group will be given an active TENS unit to use.
TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
Other Names:
  • EMPI Select Pain Control System
Sham Comparator: Sham TENS Therapy
This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.
TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
Other Names:
  • EMPI Select Pain Control System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
Time Frame: Two weeks postoperatively.
The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain
Two weeks postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kevin Marberry, MD, A.T. Still University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 3, 2012

First Submitted That Met QC Criteria

February 3, 2012

First Posted (Estimate)

February 7, 2012

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • TENS Study #110518-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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