Therapeutic Effects of Cryotherapy and Transcutaneus Nerves Stimulation on Arthrogenic Muscle Inhibition in Patients With Anterior Cruciate Ligament Reconstruction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01273649
First received: January 6, 2011
Last updated: January 7, 2011
Last verified: September 2010
  Purpose

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 transcutaneus 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 pre-surgery, 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 Intervention
Anterior Cruciate Ligament Injury
Device: cryotherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Cryotherapy and Transcutaneus Nerves Stimulation on Arthrogenic Muscle Inhibition in Patients With Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Muscle activation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: cryotherapy
    cryotherapy is given with other physical training
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: HK Wang/Associate Professor, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01273649     History of Changes
Other Study ID Numbers: 201007065R
Study First Received: January 6, 2011
Last Updated: January 7, 2011
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on May 16, 2013