Motor and Sensory Deficits Following Partial Meniscectomy
1 other identifier
interventional
60
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2013
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
January 13, 2014
CompletedFirst Posted
Study publicly available on registry
March 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedDecember 14, 2015
December 1, 2015
1.7 years
January 13, 2014
December 10, 2015
Conditions
Keywords
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)
EXPERIMENTALThe 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.
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.
Eligibility Criteria
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Terry L Grindstaff, PhD, PT, ACT
Creighton University
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