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

May 27, 2014 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University
        • Contact:

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: HK Wang, PhD, National Taiwan University Hospital

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

January 1, 2011

Primary Completion (Anticipated)

September 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

January 6, 2011

First Submitted That Met QC Criteria

January 7, 2011

First Posted (Estimate)

January 10, 2011

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 27, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201007065R

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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