Meniscus TearNCT02100059
Motor and Sensory Deficits Following Partial Meniscectomy
A study testing Transcutaneous Electrical Nerve Stimulation in people with Meniscus Tear, run by Creighton University at 1 site in United States.
Trial summary
To determine changes in thigh muscle function and knee pain after a partial meniscectomy surgery and to also determine the effects of applying electrical stimulation to the knee to determine if this improves thigh muscle function and decreases pain. Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscus Tear
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 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 15 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 15-65
- Arthroscopic partial meniscectomy with in the past 15 years
Who cannot join
- History of traumatic spine or lower extremity injury within the last 6 months
- Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
- Cardiac pacemaker
- Metal implants in head
- Current pregnancy
- Neurological disorders
- History of seizures
- Unable to give consent or understand the procedures of this study
Trial locations and contacts
1 site in 1 country.
About this study
To determine changes in thigh muscle function and knee pain after a partial meniscectomy surgery and to also determine the effects of applying electrical stimulation to the knee to determine if this improves thigh muscle function and decreases pain.
Read the detailed description
The objective for this study is to determine the differences in corticospinal excitability and central sensitization of nociceptive pathways in individuals with a history of arthroscopic partial meniscectomy compared to healthy controls. Our central hypothesis is that quadriceps weakness following partial meniscectomy is due to higher levels of corticospinal excitability and central sensitization of nociceptive pathways, which can be modified with therapeutic interventions.
- Conditions
- Meniscus Tear
- Being tested
- Transcutaneous Electrical Nerve Stimulation
- Keywords
- meniscectomy, arthroscopic partial meniscectomy, meniscus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationOther
Also called TENS, Sensory TENS
The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 40 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation (TENS) | Experimental | The TENS (transcutaneous electrical nerve stimulation) electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 40 minutes. Receives: Other: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quadriceps force output and voluntary activation
Quadriceps activation will be estimated by utilizing the burst-superimposition technique on a maximum voluntary isometric contraction (MVIC) and during a resting condition.
Measured: Single Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startOct 2013
- 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 Meniscus TearStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry L Grindstaff, PhD, PT, ACT, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100059
- Sponsor's protocol ID
- 13-16795
- Status last verified
- Dec 2015
- First submitted
- 13 Jan 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor and Sensory Deficits Following Partial Meniscectomy
- ClinicalTrials.gov ID
- NCT02100059
- Acronym / sponsor ID
- 13-16795
- Conditions
- Meniscus Tear
- Keywords
- meniscectomy, arthroscopic partial meniscectomy, meniscus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Mar 2014 (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.
To determine changes in thigh muscle function and knee pain after a partial meniscectomy surgery and to also determine the effects of applying electrical stimulation to the knee to determine if this improves thigh muscle function and decreases pain.
Detailed description
The objective for this study is to determine the differences in corticospinal excitability and central sensitization of nociceptive pathways in individuals with a history of arthroscopic partial meniscectomy compared to healthy controls. Our central hypothesis is that quadriceps weakness following partial meniscectomy is due to higher levels of corticospinal excitability and central sensitization of nociceptive pathways, which can be modified with therapeutic interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation (TENS) | Experimental | Other: Transcutaneous Electrical Nerve StimulationThe TENS (transcutaneous electrical nerve stimulation) electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 40 minutes. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age 15-65
- Arthroscopic partial meniscectomy with in the past 15 years
Key exclusion criteria (8 listed)
- History of traumatic spine or lower extremity injury within the last 6 months
- Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
- Cardiac pacemaker
- Metal implants in head
- Current pregnancy
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 |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationAlso: TENS, Sensory TENSThe TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 40 minutes. | Other | Electrical Stimulation (TENS) |
Primary outcome
Changes in quadriceps force output and voluntary activation
Time frame: Single Study Visit
Quadriceps activation will be estimated by utilizing the burst-superimposition technique on a maximum voluntary isometric contraction (MVIC) and during a resting condition.
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 14 Dec 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.
Terry L Grindstaff, PhD, PT, ACT principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation in people with Meniscus Tear, run by Creighton University at 1 site in United States.
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 2 inclusion and 8 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 14 Dec 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 United States. 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.
What does the primary outcome measure?
Changes in quadriceps force output and voluntary activation (time frame: Single Study Visit). It is what the study was designed to measure, not a finding.
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 14 Dec 2015.