Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01273649
First received: January 6, 2011
Last updated: May 27, 2014
Last verified: May 2014
  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 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 Intervention
Anterior Cruciate Ligament Injury
Device: cryotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

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 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01273649     History of Changes
Other Study ID Numbers: 201007065R
Study First Received: January 6, 2011
Last Updated: May 27, 2014
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 November 24, 2014