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OpenTrials
Completed

NCT Number: NCT01528228

Effects of TENS Therapy Following Arthroscopic Knee Surgery

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Missouri Sports Medicine and Orthopaedic Surgery

Kirksville, Missouri, 63501, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS Treatment with functional or disabled unit

Device

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

A.T. Still University of Health Sciences

Other

Registry information

Official study title

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

Acronym: TENS

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 7, 2012
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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