NCT02100059

Brief Summary

To determine changes in thigh muscle function and knee pain after a partial meniscectomy surgery and to also determine the effects of applying electrical stimulation to the knee to determine if this improves thigh muscle function and decreases pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

January 13, 2014

Last Update Submit

December 10, 2015

Conditions

Keywords

meniscectomyarthroscopic partial meniscectomymeniscus

Outcome Measures

Primary Outcomes (1)

  • Changes in quadriceps force output and voluntary activation

    Quadriceps activation will be estimated by utilizing the burst-superimposition technique on a maximum voluntary isometric contraction (MVIC) and during a resting condition.

    Single Study Visit

Study Arms (1)

Electrical Stimulation (TENS)

EXPERIMENTAL

The TENS (transcutaneous electrical nerve stimulation) electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 40 minutes.

Other: Transcutaneous Electrical Nerve Stimulation

Interventions

The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 40 minutes.

Also known as: TENS, Sensory TENS
Electrical Stimulation (TENS)

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 15-65
  • Arthroscopic partial meniscectomy with in the past 15 years

You may not qualify if:

  • History of traumatic spine or lower extremity injury within the last 6 months
  • Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
  • Cardiac pacemaker
  • Metal implants in head
  • Current pregnancy
  • Neurological disorders
  • History of seizures
  • Unable to give consent or understand the procedures of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Terry L Grindstaff, PhD, PT, ACT

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

March 31, 2014

Study Start

October 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations