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Therapeutic Effects of Cryotherapy on Arthrogenic Muscle Inhibition in Patients With Cruciate Ligament Reconstruction

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ClinicalTrials.gov Identifier: NCT01273649
Recruitment Status : Unknown
Verified May 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : January 10, 2011
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:

Anterior cruciate ligament(ACL) injury is one of the most common sport injuries. The major problem after ACL reconstruction or rehabilitation program is quadriceps weakness. Previous studies suggested that cryotherapy and transcutaneous electrical nerve stimulation(TENS) can effectively reduce the arthrogenic muscle inhibition caused by experimental swelling.

Objective:

To exam the effects of 12 weeks cryotherapy and TENS on arthrogenic muscle inhibition in subjects with ACL reconstruction.

Design:

Prospective study.

Subjects:

Male subjects with isolated ACL injury, age between 18~40 years old are going to receive an ACL reconstruction surgery.

Methods:

Quadriceps activation level, quadriceps peak torque during maximal voluntary contraction and rate of force development are measure at presurgery, 3-month, 6-month after surgery. After surgery, subjects will receive 12 weeks, 3 days/week, training programs included 20 minutes cryotherapy and exercise training with TENS.

Data analysis:

Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL). One-way ANOVA will be used to analysis data.


Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injury Device: cryotherapy Not Applicable

Detailed Description:

Examination procedure:

  1. Skin preparation and EMG setting.
  2. Fill out knee joint function questionnaire.
  3. Warmup with a stationary bike.
  4. Single hop for distance.
  5. MVIC test and EMG recording.
  6. Endurance test.
  7. Record surface EMG of vastus lateralis, vastus medialis, biceps femoris and semitendinosus during maximal voluntary contraction.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Cryotherapy and Transcutaneous Nerves Stimulation on Arthrogenic Muscle Inhibition in Patients With Anterior Cruciate Ligament Reconstruction
Study Start Date : January 2011
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: ice, rate of force development
to monitor the long term effect of cryotherapy in rate of force development.
 Device: cryotherapy
cryotherapy is given with other physical training


Outcome Measures
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Primary Outcome Measures :
  1. Muscle activation [ Time Frame: 6 months ]
    To provide information of individual muscles for the correlation analyses, parameters of muscle activation, such as the integrated electromyography (EMG) normalized to the maximal M wave, are favored.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male subjects with isolated ACL injury, age between 18~40 years old are going to receive an ACL reconstruction surgery.

Exclusion Criteria:

  • meniscus lesion, bony fracture and osteochondral lesions
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273649


Contacts
Contact: HK Wang, PhD hkwang@ntu.edu.tw

Locations
Taiwan
National Taiwan University Recruiting
Taipei, Taiwan, 100
Contact: HK Wang, PhD    00886-02-33668134    hkwang@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: HK Wang, PhD National Taiwan University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01273649     History of Changes
Other Study ID Numbers: 201007065R
First Posted: January 10, 2011    Key Record Dates
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by National Taiwan University Hospital:
muscle activation
ACL reconstruction
cryotherapy
TENS

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries