Knee InjuriesNCT01633047
Electrostimulation in Anterior Cruciate Ligament Reconstruction
A study testing electrical stimulation and physical therapy exercises in people with Knee Injuries, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries
- What is being tested?
- electrical stimulation and physical therapy exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2015to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects between 18 e 45 years old, submitted in the last 15 days to the ACL reconstruction surgery, being the first knee lesion episode.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Knee Injuries
- Being tested
- electrical stimulation, physical therapy exercises
- Keywords
- Anterior Cruciate Ligament, Electric Stimulation Therapy
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulationOther
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)
physical therapy exercisesOther
Control group that will be submitted only to physical therapy exercises
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | The subjects on this group will be submitted to a conventional rehabilitation (ROM increase, strength recovery, functional training) associated with electrostimulation. Receives: Other: electrical stimulation; Other: physical therapy exercises |
| Physical therapy exercises | Active comparator | The subjects on this group will be submitted to a conventional rehabilitation (ROM increase, strength recovery, functional training). Receives: Other: physical therapy exercises |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJun 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tiago Alves Bozzo, Federal University of São Paulo
- Investigators
- Tiago A Bozzo, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633047
- Sponsor's protocol ID
- CAAE 01430812.1.0000.5505
- Status last verified
- Jul 2015
- First submitted
- 3 Jul 2012
- Last updated
- 20 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01633047
- Acronym / sponsor ID
- CAAE 01430812.1.0000.5505
- Conditions
- Knee Injuries
- Keywords
- Anterior Cruciate Ligament, Electric Stimulation Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation | Experimental | Other: electrical stimulation, Other: physical therapy exercisesThe subjects on this group will be submitted to a conventional rehabilitation (ROM increase, strength recovery, functional training) associated with electrostimulation. |
| Physical therapy exercises | Active comparator | Other: physical therapy exercisesThe subjects on this group will be submitted to a conventional rehabilitation (ROM increase, strength recovery, functional training). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subjects between 18 e 45 years old, submitted in the last 15 days to the ACL reconstruction surgery, being the first knee lesion episode.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical stimulationIntervention 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 | Electrical stimulation |
| physical therapy exercisesControl group that will be submitted only to physical therapy exercises | Other | Electrical stimulation, Physical therapy exercises |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiago A Bozzo principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation and physical therapy exercises in people with Knee Injuries, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2015.