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Effects of TENS Therapy Following Arthroscopic Knee Surgery (TENS)

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ClinicalTrials.gov Identifier: NCT01528228
Recruitment Status : Completed
First Posted : February 7, 2012
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
A.T. Still University of Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Meniscus Tear Device: TENS Treatment with functional or disabled unit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Postoperative Pain and Function Following Arthroscopic Knee Surgery: A Prospective Randomized Clinical Trial Pilot Study
Study Start Date : July 1, 2011
Actual Primary Completion Date : April 1, 2012
Actual Study Completion Date : April 1, 2012

Arm Intervention/treatment
Active Comparator: Structured TENS Therapy
This group will be given an active TENS unit to use.
Device: TENS Treatment with functional or disabled unit
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 Name: 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.
Device: TENS Treatment with functional or disabled unit
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 Name: EMPI Select Pain Control System




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01528228


Locations
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United States, Missouri
North Missouri Sports Medicine and Orthopaedic Surgery
Kirksville, Missouri, United States, 63501
Sponsors and Collaborators
A.T. Still University of Health Sciences
Investigators
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Principal Investigator: Kevin Marberry, MD A.T. Still University
  Study Documents (Full-Text)

Documents provided by A.T. Still University of Health Sciences:
Informed Consent Form  [PDF] April 1, 2011


Publications:

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Responsible Party: A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier: NCT01528228     History of Changes
Other Study ID Numbers: TENS Study #110518-001
First Posted: February 7, 2012    Key Record Dates
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019
Last Verified: January 2019