- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01786772
Neuromuscular Consequences of Knee Arthroscopy
February 22, 2018 updated by: Creighton University
To determine changes in quadriceps muscle function following the application of ice and compression to the knee.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Novel rehabilitation methods, that specifically target decreased muscle activation due to joint pathology prior to strength training, have elicited greater improvements in muscle function and self-reported disability compared to traditional therapies.
Preliminary evidence suggests applying cryotherapy to a joint prior to exercise can increase quadriceps activation.
It is unknown if applying cryotherapy and intermittent pneumatic compression can also increase quadriceps force output and voluntary activation.
The purpose of this study is to determine changes in quadriceps force output and voluntary activation following the application of cryotherapy and compression.
The investigators hypothesize there will be an increase in quadriceps force output and voluntary activation following the application of cryotherapy and compression.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
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Omaha, Nebraska, United States, 68178
- Creighton University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 15-65 years
- BMI < 30
- Candidate for arthroscopic knee surgery to address meniscus pathology or arthroscopic knee surgery within the past 2 years.
Exclusion Criteria:
- Participants who are outside of age range
- Ligamentous insufficiency or repair
- Participants with traumatic spine or lower extremity injury within past 6 months
- Participants who have had previous adverse reactions to electrical stimulation or cryotherapy (i.e. burns, hypersensitivity)
- Medical conditions which would be contraindications to electrical stimulation or transcranial magnetic stimulation, including cardiac pacemaker, metal implants in the head, current pregnancy, neurological disorders, and history of seizures
- Participants who are unable to give consent or are unable to understand procedures of experiment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryotherapy and compression
Cryotherapy and intermittent pneumatic compression will be applied to the knee joint using a recirculating compression unit and knee sleeve.
This unit will recirculate water which is between 1-3° C. Circumferential intermittent pneumatic compression to the knee joint (5 to 50 mm Hg) will be applied in conjunction with cryotherapy.
The duration of intervention will be 20 minutes.
|
Cryotherapy and intermittent pneumatic compression will be applied to the knee joint using a recirculating compression unit and knee sleeve.
This unit will recirculate water which is between 1-3° C. Circumferential intermittent pneumatic compression to the knee joint (5 to 50 mm Hg) will be applied in conjunction with cryotherapy.
The duration of intervention will be 20 minutes.
Other Names:
|
Active Comparator: Cryotherapy
Cryotherapy will be applied to the knee joint using a recirculating compression unit and knee sleeve.
This unit will recirculate water which is between 1-3° C. The duration of intervention will be 20 minutes.
|
Cryotherapy will be applied to the knee joint using a recirculating compression unit and knee sleeve.
This unit will recirculate water which is between 1-3° C. The duration of intervention will be 20 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in quadriceps force output and voluntary activation
Time Frame: Baseline and immediately following intervention (Single Study Visit)
|
Quadriceps activation will be estimated by utilizing the burst-superimposition technique on a maximum voluntary isometric contraction (MVIC) and during a resting condition.
The burst-superimposition technique provides the muscle with a percutaneous stimulus to recruit any remaining muscle fibers which have not been stimulated.
|
Baseline and immediately following intervention (Single Study Visit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
December 7, 2012
First Submitted That Met QC Criteria
February 6, 2013
First Posted (Estimate)
February 8, 2013
Study Record Updates
Last Update Posted (Actual)
February 26, 2018
Last Update Submitted That Met QC Criteria
February 22, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NCT12-16517
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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