Rupture of Anterior Cruciate LigamentNCT00971451
Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction
A study testing cryotherapy and TENS in people with Rupture of Anterior Cruciate Ligament, run by University of Virginia at 1 site in United States.
Trial summary
Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be recruited to participate. All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior to their surgery. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- What is being tested?
- cryotherapy and TENS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2011
- 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 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Complete ACL rupture
- Age 15-55
Who cannot join
- Persons who cannot tolerate knee joint TENS.
- Persons who have a known allergy to cryotherapy
- Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Joseph M Hart, PhD, 434-243-0256, jmh3zf@virginia.edu
Joseph M Hart, Ph.D.
About this study
Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be recruited to participate.
All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior to their surgery. Each session will include supervised therapeutic exercises. Subjects will be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS) during each session or knee joint cryotherapy prior to each exercise session. The investigators will measure quadriceps function before and after this 2-week intervention (both sessions occur prior to reconstruction surgery). This study will also have a true control group that will not receive either exercise of modality intervention. The investigators will collect subjective and objective outcomes data at regularly scheduled post-operative visits.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Being tested
- cryotherapy, TENS
- Keywords
- Anterior cruciate ligament, ACL
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyOther
20 minutes of knee joint cryotherapy - ice bag application
TENSOther
continuous use of TENS during the exercise session
| Study group | Role | What they receive |
|---|---|---|
| knee joint cryotherapy | Experimental | 20 minutes of knee joint cryotherapy - ice bag application Receives: Other: cryotherapy |
| TENS | Experimental | continuous TENS for duration of the 1 hour exercise session Receives: Other: TENS |
| No intervention | No intervention | no modality intervention; just exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle strength and inhibition using the quadriceps central activation ratio
Measured: Day 15
Secondary outcomes (4)
Quadriceps H-reflex testing
Measured: Day 15
International Knee Documentation Committee Subjective Knee Joint Evaluation
Measured: Day 15
Visual Analog Scale
Measured: Day 15
Tegner Activity Rating
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startNov 2007
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Joseph M Hart, Ph.D., Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971451
- Sponsor's protocol ID
- 13398
- Status last verified
- Mar 2011
- First submitted
- 2 Sep 2009
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadriceps Function Prior to Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT00971451
- Acronym / sponsor ID
- 13398
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- Anterior cruciate ligament, ACL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 3 Sep 2009 (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.
Patients who are diagnosed with an isolated tear of the anterior cruciate ligament and scheduled for arthroscopic reconstruction using bone-patellar tendon-bone autograft will be recruited to participate.
All subjects will be invited to participate in 2 weeks (2 supervised sessions per week) prior to their surgery. Each session will include supervised therapeutic exercises. Subjects will be randomly assigned to receive continuous transcutaneous electrical nerve stimulation (TENS) during each session or knee joint cryotherapy prior to each exercise session. The investigators will measure quadriceps function before and after this 2-week intervention (both sessions occur prior to reconstruction surgery). This study will also have a true control group that will not receive either exercise of modality intervention. The investigators will collect subjective and objective outcomes data at regularly scheduled post-operative visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| knee joint cryotherapy | Experimental | Other: cryotherapy20 minutes of knee joint cryotherapy - ice bag application |
| TENS | Experimental | Other: TENScontinuous TENS for duration of the 1 hour exercise session |
| No intervention | No intervention | –no modality intervention; just exercise |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Complete ACL rupture
- Age 15-55
Key exclusion criteria (3 listed)
- Persons who cannot tolerate knee joint TENS.
- Persons who have a known allergy to cryotherapy
- Patients who are pregnant or who plan on getting pregnant during the 12-month follow-up period.
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 |
|---|---|---|
| cryotherapy20 minutes of knee joint cryotherapy - ice bag application | Other | knee joint cryotherapy |
| TENScontinuous use of TENS during the exercise session | Other | TENS |
Primary outcome
Quadriceps muscle strength and inhibition using the quadriceps central activation ratio
Time frame: Day 15
4 secondary outcomes
Quadriceps H-reflex testing
Time frame: Day 15
International Knee Documentation Committee Subjective Knee Joint Evaluation
Time frame: Day 15
Visual Analog Scale
Time frame: Day 15
Tegner Activity Rating
Time frame: Day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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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.
Joseph M Hart, Ph.D. principal investigator
University of Virginia
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 TENS in people with Rupture of Anterior Cruciate Ligament, run by University of Virginia 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Mar 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph M Hart, Ph.D. (434-243-0256, jmh3zf@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps muscle strength and inhibition using the quadriceps central activation ratio (time frame: Day 15). 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 8 Mar 2011; AzTrials last refreshed its copy on 6 Nov 2026.