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Effects of TENS Therapy Following Arthroscopic Knee Surgery

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01528228
First received: February 3, 2012
Last updated: February 8, 2012
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Meniscus Tear
 Device: TENS Treatment with functional or disabled unit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Disabilities
U.S. FDA Resources

Further study details as provided by A.T. Still University of Health Sciences:

Primary Outcome Measures:
  • Patient's perception of pain in the early post-operative period while utilizing structured TENS therapy. [ Time Frame: Two weeks postoperatively. ] [ Designated as safety issue: No ]
    The patient participant will record pain levels during the immediate post-op 2-week time period.


Secondary Outcome Measures:
  • Short-term (6 months) outcomes following knee arthroscopy while using TENS in the early post-operative period. [ Time Frame: Six months postoperatively. ] [ Designated as safety issue: No ]
    The patient participant will record information at various times during the 6-month postoperative period to provide information about their abilities, activity levels, symptom levels, pain levels, knee related quality of life, knee surgery evaluation follow-up.

  • Effect of early TENS use on quadriceps strength and tone in the early and intermediate post-operative periods. [ Time Frame: Six months postoperatively. ] [ Designated as safety issue: No ]
    Measurements will be taken pre and postoperatively to evaluate changes related to range of motion, effusion, quadriceps strength and circumference.


Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01528228

Locations
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
Principal Investigator: Kevin Marberry, MD A.T. Still University
  More Information

No publications provided

Responsible Party: A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier: NCT01528228     History of Changes
Other Study ID Numbers: TENS Study #110518-001
Study First Received: February 3, 2012
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013