Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05976269 |
| Other study ID # |
2020H0332 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 21, 2020 |
| Est. completion date |
July 21, 2030 |
Study information
| Verified date |
April 2024 |
| Source |
Ohio State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This project will evaluate the effects of bilateral knee pain and dry needling (DN) on
laterality recognition, movement and muscle function. The objective is to determine if
laterality recognition accuracy deficits are present in individuals with bilateral chronic
knee pain and if DN affects 'central' and 'peripheral' musculoskeletal measurements. Chronic
musculoskeletal pain results in changes to the way the brain perceives pain and left-right
discrimination between body parts. This phenomenon has been established for individuals with
chronic back pain and chronic regional pain syndrome, but has not been described for
individuals with bilateral knee pain without the presence of knee OA. Dry needling involves
the insertion of a small diameter monofilament needle into muscle, and has been purported to
affect the neuromuscular system both centrally and peripherally. Sixty individuals between 18
and 40 years old will be recruited and allocated into three groups. The first group will
consist of 20 subjects presenting with bilateral chronic anterior knee pain and high fear of
movement with scores on Tampa Kinesiophobia Scale (fear of movement) greater than 37. The
second group with consist of 20 subjects with bilateral chronic anterior knee pain and low
fear of movement between ages of 18 and 40 years old, and the third group will consist of
healthy controls without knee pain between 18 and 40 years old. All subjects will undergo
baseline testing consisting of laterality recognition, movement analysis, muscle force
production, and ultrasound imaging. Subjects will undergo laterality recognition testing
using the Neuro Orthopaedic Institute (NOI) Recognise Knee phone application. 2D video
analysis of the lateral step down test will be performed followed by peak isometric force
production assessment of knee extension and flexion. Muscle function of the vastus medialis
will be measured with ultrasound imaging where cross-sectional area and other measurements
(tendon length, muscle thickness, etc) will be captured with Lumify ultrasound imaging
transducer. Then DN to the quadriceps will be performed. After DN procedure, subjects will
undergo aforementioned measurements from baseline testing. Testing will require only one
appointment by the subject, which will last approximately 2 hours an include baseline
testing, dry needling, and post testing. No follow up will occur afterwards.
Description:
The primary purpose of this study is to identify if a loss of laterality recognition is
present in individuals with bilateral chronic knee pain with kinesiophobia and if DN affects
short term central and peripheral neuromuscular measurements. The goal of this project is to
recruit 20 individuals with bilateral knee pain greater than three months between the ages of
18 and 40 years old without evidence of knee OA and with fear of movement as evidenced by the
Tampa Scale of Kinesiophobia with the following aims: Determine if these individuals have a
loss of laterality recognition associated with chronic pain that affects the way the brain
processes images of a left or right knee using the Neuro Orthopaedic Institute (NOI)
Recogonise Knee phone application for iPhone or Android. Assess muscle force production by
measuring peak knee extension and flexion isometric force production on a Biodex System II
dynamometer (Biodex Medical Systems, Inc. Shirley, New York, USA). Measure muscle function of
the quadriceps using ultrasound imaging to assess for changes in cross sectional area, tendon
length, muscle thickness, and other relevant measurements that could be captured (i.e.
pennation angle) of the vastus medialis (VM) muscle. Assess movement quality with the lateral
step down test and using 2D video analysis measure trunk flexion, knee flexion, closed chain
dorsiflexion, pelvic drop and patellar projection angle. Determine if DN causes an immediate
change on the central (laterality recognition) and peripheral (muscle force production,
function, movement) neuromuscular system. Elucidate if there are differences between
individuals with bilateral knee pain and high fear of movement and bilateral knee pain and
low fear of movement. The investigators also will recruit 20 subjects with bilateral knee
pain and low fear of movement, and 20 subjects who are healthy without any knee pain. To the
authors knowledge only one study has identified laterality recognition deficits in a
population with knee OA. Currently there is not a single publication that assesses laterality
recognition deficits for individuals with bilateral knee pain without the presence of knee
OA. This study has the potential to inform physical therapists that deliver interventions
such as pain neuroscience education, graded motor imagery (left-right discrimination,
explicit motor imagery, mirror therapy), movement/muscle function assessment, and DN, to
improve their decision-making, evaluation, and treatment skills.
To facilitate recruitment the investigators are applying for a partial HIPAA waiver for this
project in order to recruit patients undergoing/seeking care for their knee pain with a
physician or physical therapist. The only pertinent PHI to be screened will be age, diagnosis
codes related to knee pain, and factors related to inclusion and exclusion criteria. Of this
information, only eligibility criteria (inclusion/exclusion factors) will be screened by the
research team. This information screened in the electronic medical record will not be written
down or stored anywhere. Once a research associate identifies a patient that may qualify for
the study, the patient will fill out a survey link from REDCap, where the data will be stored
containing their name, contact information, and screening questions related to their
eligibility of the study (inclusion/exclusion criteria). This information will be preserved
in REDCap, a secure online platform for data storage, for the sole purpose of avoiding
contacting subjects repetitively regarding interest in study participation. Only pertinent
PHI will be screened such as age, diagnosis codes related to knee pain, and factors related
to inclusion and exclusion criteria. None of this information will be stored by the research
team. Once a research associate identifies a patient that may qualify for the study, the
patient will fill out a survey link from REDCap, where the data will be stored containing
their name, contact information, and screening questions related to their eligibility of the
study. Participants in this study do not have to be current patients. If a potential
participant who is not a current patient reaches out to the research team, they will be given
the survey link from REDCap. After this survey is completed, a research associate will
determine their eligibility for the study. This means recruits for the study may come from
the community who have not necessarily seen a PT, MD, or DO. All interventions, including dry
needling, and outcomes measured (pain, outcome questionnaires, strength, range of motion,
functional assessment, etc.) are commonly performed during current physical therapy practice
and treatment. For this study the investigators are formalizing the collection of these
measures. Testing will require only one appointment by the subject, which will last
approximately 2 hours an include baseline testing, dry needling, and post testing. No follow
up will occur afterwards. Specific testing procedures related to this protocol include the
following: Laterality recognition testing, where the subject will look through an application
called NOI Recognoise Knee on an iPhone or iPad and select if the image they are looking at
is a left or right knee. Cross-sectional area and other measurements (tendon length, muscle
thickness, etc) of vastus medialis muscle measured in supine with Lumify ultrasound imaging
transducer. 2D movement analysis will be performed of subjects performing the lateral step
down test. Peak knee extension and flexion isometric force production will be captured using
the Biodex. Dry needling will be provided to all subjects using a clean technique commonly
used in clinical care. Dry needling intervention will be provided to the quadriceps muscle
using a standardized protocol. Dry needle will be inserted in and out and/or twisted
clockwise for a maximum of 30" at the discretion of the researcher and tolerance of
participant, and then the needle will be left in situ for 15 minutes. Several studies have
demonstrated the safety of this technique. If participant is unable to tolerate the DN
procedure, the procedure will be stopped and needles removed. The participant can stop
participation at any time during the study. Step 1-4 will be repeated. In summary, the
process will look like this: Consent, Baseline testing, dry needling, post testing in a 2
hour session. In addition, specific examination data from the subjects' will be recorded such
as age, height, weight and details about their knee pain. Both electronic and paper
collection of data and questionnaires will be used for the study. This study will utilize
REDCap (Research Electronic Data Capture), a software tool set and workflow methodology for
electronic collection and management of clinical and research data, to collect and store
data. REDCap will be used as the primary tool to collect and manage the study documentation
as it pertains to the screening, data collection, and participant questionnaires. Paper
documentation will also be available. The paper documentation would be used if the REDCap
system could not be accessible for some reason including but not limited to internet outage,
computer technical difficulties (hardware and/or software), loss of power, etc.
Testing will require only one appointment by the subject, which will last approximately 2
hours an include baseline testing, dry needling, and post testing. No follow up will occur
afterwards. Once subjects have been screened and have agreed to be included in the study they
will be scheduled for a 2 hour testing session. The subject will then undergo informed
consent, baseline testing, dry needling, and post testing. Currently the investigators only
have funding for 10 subjects who have bilateral knee pain and high fear of movement. They
will receive a consent form that details the honorarium they will receive. Those who meet the
inclusion criteria of the other groups that investigators don't have funding for, will
receive a different consent and hippa form that has all the same details as the other form
without the honorarium information. Testing will take approximately 2 hours. 10 minutes will
be allocated for consent and questions. 45 minutes will be allocated to the baseline testing.
15 minutes will be allocated to the dry needling procedure. 45 minutes will be allocated for
post testing. 5 minutes will be allocated for concluding the study. Summary of two hour
testing session Step 1: Consent Subject: subjects will have already filled out screening
questionnaire (inclusions criteria Table 1). The informed consent process will occur and
patients will be given the option to consent to participate and continue in the study. Step
2: Laterality Recognition: Basic - Images of left and right knees with plain background
Vanilla - Basic images of left and right knees in different orientations Context - Images of
left and right knees in real life activities Abstract - Images of left and right knees with
various artwork and statues Step 3: Lateral Step Down Test: 2D video analysis performed with
two Go Pros to capture the five repetitions of subject performing lateral step down test in
frontal and sagittal plane. Step 4: Muscle Force Production: Peak knee extension and flexion
isometric force production captured on Biodex. Step 5: Muscle Function: Cross-sectional area
of vastus medialis muscle measured in supine with Lumify ultrasound imaging transducer. Step
6: Dry Needling: Dry needles inserted into distal vastus lateralis, rectus femoris and vastus
medialis muscles. Needle inserted maximally and left in situ for 15 minutes. Step 7: Repeat
steps 2 thru 5: Repeat laterality recognition testing, lateral step down test, muscle force
production, and muscle function testing.
The investigators plan to recruit 60 subjects; 40 with bilateral knee pain and divide them in
two different groups: high fear (Tampa Kinesiophobia Scale > 37), low fear (Tampa
Kinesiophobia Scale = or < 37), and 20 healthy controls into a group without knee pain. In
order to be adequately powered, our goal is to recruit 20 subjects per group. Currently the
investigators only have funding for 10 subjects who have bilateral knee pain and high fear of
movement. They will receive a consent form that details the honorarium they will receive.
Those who meet the inclusion criteria of the other groups that investigators don't have
funding for, will receive a different consent and hippa form that has all the same details as
the other form without the honorarium information. Based on previous research and sample size
power calculation using the statistical analysis software STATA, 10 subjects are required to
yield a medium effect size, alpha level of 0.01 and power level of 0.80. This meets our goal
of being adequately powered to assess for laterality recognition deficits, however the
investigators plan to recruit 60 total subjects with 20 subjects for each group so the
investigators can be adequately powered to assess for differences in each group for all
mentioned variables.
