Tear of Fibrocartilage of JointNCT01786772
Neuromuscular Consequences of Knee Arthroscopy
A study testing Cryotherapy and compression and Cryotherapy in people with Tear of Fibrocartilage of Joint, run by Creighton University at 1 site in United States.
Trial summary
To determine changes in quadriceps muscle function following the application of ice and compression to the knee. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Tear of Fibrocartilage of Joint
- What is being tested?
- Cryotherapy and compression and Cryotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 15-65 years
- BMI < 30
- Candidate for arthroscopic knee surgery to address meniscus pathology or arthroscopic knee surgery within the past 2 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To determine changes in quadriceps muscle function following the application of ice and compression to the knee.
Read the 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.
- Conditions
- Tear of Fibrocartilage of Joint
- Being tested
- Cryotherapy and compression, Cryotherapy
- Keywords
- arthroscopic partial meniscectomy, meniscus, quadriceps strength, quadriceps voluntary activation, cryotherapy, compression, vasopneumatic compression, intermittent pneumatic compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy and compressionOther
Also called Cryotherapy and intermittent pneumatic compression, Cryotherapy and vasopneumatic compression, Gameready
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.
CryotherapyOther
Also called Ice, Gameready
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy and compression | Experimental | 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. Receives: Other: Cryotherapy and compression |
| Cryotherapy | Active comparator | 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. Receives: Other: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. The burst-superimposition technique provides the muscle with a percutaneous stimulus to recruit any remaining muscle fibers which have not been stimulated.
Measured: Baseline and immediately following intervention (Single Study Visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tear of Fibrocartilage of JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry L Grindstaff, PhD, PT, ATC, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786772
- Sponsor's protocol ID
- NCT12-16517
- Status last verified
- Feb 2018
- First submitted
- 7 Dec 2012
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Consequences of Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT01786772
- Acronym / sponsor ID
- NCT12-16517
- Conditions
- Tear of Fibrocartilage of Joint
- Keywords
- arthroscopic partial meniscectomy, meniscus, quadriceps strength, quadriceps voluntary activation, cryotherapy, compression, vasopneumatic compression, intermittent pneumatic compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine changes in quadriceps muscle function following the application of ice and compression to the knee.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy and compression | Experimental | Other: Cryotherapy and compressionCryotherapy 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 | Active comparator | Other: CryotherapyCryotherapy 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. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age 15-65 years
- BMI < 30
- Candidate for arthroscopic knee surgery to address meniscus pathology or arthroscopic knee surgery within the past 2 years.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryotherapy and compressionAlso: Cryotherapy and intermittent pneumatic compression, Cryotherapy and vasopneumatic compression, GamereadyCryotherapy 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 | Cryotherapy and compression |
| CryotherapyAlso: Ice, GamereadyCryotherapy 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 | Cryotherapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry L Grindstaff, PhD, PT, ATC principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy and compression and Cryotherapy in people with Tear of Fibrocartilage of Joint, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in quadriceps force output and voluntary activation (time frame: Baseline and immediately following intervention (Single Study Visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2018.