Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

Electrostimulation in Anterior Cruciate Ligament Reconstruction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tiago Alves Bozzo, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01633047
First received: July 3, 2012
Last updated: July 16, 2015
Last verified: July 2015
History of Changes
  Purpose

The anterior cruciate ligament (ACL) is frequently injured, and it is the structure of the athlete´s knee which has the highest prevalence of reconstruction. Given this postoperative ACL reconstruction scenario the investigator find in literature the effectiveness of neuromuscular electrical stimulation (NMES) as an adjuvant treatment for strengthening the quadriceps muscle. The intensity of NMES and the training duration are important factors for a successful treatment.

The purpose of this study is to compare two rehabilitation protocols in patients during the post operative of the ACL reconstruction over the strength of knee extension and control of edema.

It will be a randomized controlled study with the CONSORT bases with 40 participants that will be divided into two groups: Control group that will be submitted only to physical therapy exercises, and the Intervention group that will be submitted to physical therapy exercises plus electrical stimulation (low frequency device with a current of 47 Hz with symmetrical, biphasic and pyramidal waveforms, with pulse duration of 1.5 s and interval of 1.8 s). The procedure will last six weeks. It will be evaluated the pre intervention quadriceps muscle extension force by means of a manual dynamometer, and the joint swelling through the perimeter. This procedure will be repeated after six weeks of intervention.


Condition Intervention
Knee Injuries
 Other: electrical stimulation
Other: physical therapy exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Low Frequency Neuromuscular Electrical Stimulation Applied to the Quadriceps in the Production of Knee Extension Strength and Control of Edema After Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:
Enrollment: 24
Study Start Date: June 2015
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electrical stimulation
The subjects on this group will be submitted to a conventional rehabilitation (ROM increase, strength recovery, functional training) associated with electrostimulation.
 Other: electrical stimulation
Intervention group that will be submitted to physical therapy exercises plus electrical stimulation (low frequency device with a current of 47 Hz with symmetrical, biphasic and pyramidal waveforms, with pulse duration of 1.5 s and interval of 1.8 s)
Other: physical therapy exercises
Control group that will be submitted only to physical therapy exercises
Active Comparator: Physical therapy exercises
The subjects on this group will be submitted to a conventional rehabilitation (ROM increase, strength recovery, functional training).
 Other: physical therapy exercises
Control group that will be submitted only to physical therapy exercises

Detailed Description:

Participants Twenty-two patients that submitted to ACL surgical reconstruction with flexor grafts less than 15 days previously will be included in the study, both genders, between 18-45 years old. Individuals with previous knee lesions, other ligament injuries, osteochondritis or associated menisci repair and complications during surgery will not be included in the study. Patients that carried out complimentary therapies to the proposed treatment will be excluded.

The participants will be randomized into two groups: control and electrical stimulation group

. Intervention All the subjects will be submitted to physiotherapy sessions three times a week, following a 12 weeks criterion based reahabilitation, carried out in line with the objectives proposed for each rehabilitation phase (immediate post-operative, early post-operativeand late post-operative). A group of trained physiotherapists will design the exercises and determinate their evolution, including range of motion improvement, muscular control and strength, gait training with progression in weight bearing and sensory-motor control training, according to the established guidelines.

The patients from the electrical stimulation group will receive, in addition, NMES application in the first six weeks of treatment, using an electrical stimulator with a carrier frequency of 47 Hz with symmetrical, biphasic and pyramidal waves, with pulse duration of 150 µs and duty cycle of 1,5 sec on and 1,8 sec off.

Evaluation It will be evaluated the pre intervention quadriceps muscle extension force by means of a manual dynamometer, and the joint swelling through the perimeter. This procedure will be repeated after six weeks of intervention.

  Eligibility
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects between 18 e 45 years old, submitted in the last 15 days to the ACL reconstruction surgery, being the first knee lesion episode.

Exclusion Criteria:

  • Patients cannot present any constrains regarding the physical activity practice according to the Sports Medicine American College.
  • cartilage degeneration with a degree higher than 2 according to the cartilage Repair International Society
  • Presence of other ligamentary lesions associated to the ACL reconstruction.
  • Utilization of complementary therapies parallel to the treatment.
  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: NCT01633047

Locations
Brazil
Universidade Federal de São Paulo
São Paulo, SP, Brazil, 04039-001
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Tiago A Bozzo Federal University of São Paulo
  More Information

Responsible Party: Tiago Alves Bozzo, Dr., Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01633047     History of Changes
Other Study ID Numbers: CAAE 01430812.1.0000.5505 
Study First Received: July 3, 2012
Last Updated: July 16, 2015
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health
Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Anterior Cruciate Ligament
Electric Stimulation Therapy

Additional relevant MeSH terms:
Knee Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 23, 2016