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Effects of TENS Therapy Following Arthroscopic Knee Surgery

Sponsor
A.T. Still University of Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01528228
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
9
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: TENS Treatment with functional or disabled unit
 N/A

Study Design

Study Type:
Interventional
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 :
Jul 1, 2011
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

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 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.

    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 Names:
  • EMPI Select Pain Control System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    A.T. Still University of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01528228
    Other Study ID Numbers:
    • TENS Study #110518-001
    First Posted:
    Feb 7, 2012
    Last Update Posted:
    Jan 11, 2019
    Last Verified:
    Jan 1, 2019

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Structured TENS Therapy Sham TENS Therapy
    Arm/Group Description This group will be given an active TENS unit to use. 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. 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 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.
    Period Title: Overall Study
    STARTED 10 10
    COMPLETED 9 9
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title Structured TENS Therapy Sham TENS Therapy Total
    Arm/Group Description This group will be given an active TENS unit to use. 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. 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 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. Total of all reporting groups
    Overall Participants 10 10 20
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    46.6
    (9.0)
    53.3
    (7.0)
    50.0
    (8.5)
    Sex: Female, Male (Count of Participants)
    Female
    5
    50%
    3
    30%
    8
    40%
    Male
    5
    50%
    7
    70%
    12
    60%

    Outcome Measures

    1. Primary Outcome
    Title Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
    Description 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
    Time Frame Two weeks postoperatively.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Structured TENS Therapy Sham TENS Therapy
    Arm/Group Description This group will be given an active TENS unit to use. 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. 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 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.
    Measure Participants 9 9
    Day 0
    5.10
    5.24
    Day 1
    4.68
    4.07
    Day 2
    3.41
    3.28
    Day 3
    2.78
    2.95
    Day 4
    2.49
    3.22
    Day 5
    3.00
    3.26
    Day 6
    2.20
    2.72
    Day 7
    2.42
    2.78
    Day 8
    3.12
    2.63
    Day 9
    2.59
    2.35
    Day 10
    2.85
    2.30
    Day 11
    2.62
    2.93
    Day 12
    2.50
    2.66
    Day 13
    2.42
    3.02
    Day 14
    2.33
    3.20

    Adverse Events

    Time Frame 2 weeks
    Adverse Event Reporting Description Transcutaneous Electrical Nerve Stimulation (TENS) therapy is considered an appropriate non-pharmacologic adjunct for the treatment of symptomatic knee arthritis. Since the electrical stimulation applied is minimal, the participants were at no risk of adverse events.
    Arm/Group Title Structured TENS Therapy Sham TENS Therapy
    Arm/Group Description This group will be given an active TENS unit to use. 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. 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 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.
    All Cause Mortality
    Structured TENS Therapy Sham TENS Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/10 (0%) 0/10 (0%)
    Serious Adverse Events
    Structured TENS Therapy Sham TENS Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/10 (0%) 0/10 (0%)
    Other (Not Including Serious) Adverse Events
    Structured TENS Therapy Sham TENS Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/10 (0%) 0/10 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Corey Luebbering
    Organization A.T. Still University
    Phone 660.626.2147
    Email coreyluebbering@atsu.edu
    Responsible Party:
    A.T. Still University of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT01528228
    Other Study ID Numbers:
    • TENS Study #110518-001
    First Posted:
    Feb 7, 2012
    Last Update Posted:
    Jan 11, 2019
    Last Verified:
    Jan 1, 2019