Motor and Sensory Deficits Following Partial Meniscectomy

Meniscus Tear Clinical Trial

Official title:

Motor and Sensory Deficits Following Partial Meniscectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100059
• Other study ID #: 13-16795
• Status: Completed
• Phase: N/A
• First received: January 13, 2014
• Last updated: December 10, 2015
• Start date: October 2013
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The objective for this study is to determine the differences in corticospinal excitability and central sensitization of nociceptive pathways in individuals with a history of arthroscopic partial meniscectomy compared to healthy controls. Our central hypothesis is that quadriceps weakness following partial meniscectomy is due to higher levels of corticospinal excitability and central sensitization of nociceptive pathways, which can be modified with therapeutic interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 15-65

• Arthroscopic partial meniscectomy with in the past 15 years

Exclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniscus Tear

Intervention

Other:
• Transcutaneous Electrical Nerve Stimulation
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.

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No