Knee Osteoarthritis Clinical Trial
Official title:
Rate of Torque Development and Voluntary Quadriceps Activation in Patients With Knee Osteoarthritis: A Quantitative Analysis Before and After a Single Session of Manual Physical Therapy - A Randomized Controlled Trial
This is a randomized control trial to determine if there is a measurable change in voluntary
quadriceps activation, RTD, pain, and function before and after a single session of manual
physical therapy.
The researchers will utilize a sample of convenience with consecutive sampling at the Brooke
Army Medical Center physical therapy clinic for patients referred for knee osteoarthritis.
As is standard of care, patients will be provided a medical intake form and a clinical
outcome measure commensurate with their primary anatomic region for which they are seeking
physical therapy (i.e.: Lower Extremity Functional Scale for hip, knee, or ankle pain). If
patients choose to partake in the study, they will complete the consent form and the initial
physical therapy evaluation will be conducted. They will then be provided an appointment for
data collection at the Army-Baylor Center for Rehabilitation Research biomechanics lab at the
Army Medical Department Center and School.
The treatment group will receive one 30-minute session of orthopedic manual physical therapy
targeting the knee joint and soft tissues with complementary exercises targeted at their
impairment.
The control group will receive a 30-minute class on knee OA diagnosis, prognosis, various
treatment options, and will conclude with a question and answer with the researcher. Both
groups will receive their intervention from a board-certified physical therapist in the
Army-Baylor Orthopedic Manual Therapy Fellowship program.
At the conclusion of formal testing, the patient will be provided standard physical therapy
care as deemed appropriate by their evaluating physical therapist. Thus, all subjects,
regardless of their assigned group, will receive the same standard of care for their knee
pain.
By participating in this study, it will not alter the standard of care provided during the
course of the patient's rehabilitation in physical therapy. During the initial physical
therapy evaluation, a member of the research team will determine if the patient would like to
participate in the study and if they choose to do so they will then be consented. Based on
the clinical presentation the standard evaluation will determine the primary limitations of
the knee joint and surrounding soft tissue structures and outline the best course of manual
physical therapy intervention deemed appropriate.
Should the patient choose to participate, they will then complete a pre-test maximal
isometric contraction in the knee extension machine in the physical therapy clinic; this is
an exercise device commonly used to strengthen the quadriceps muscles for patients with
various types of lower extremity pathology. Patients will be monitored for any changes in
pain during this screening pre-test in accordance with the Physical Therapy service standard
operating procedures; those whom pain increases more than 3/10 points on the numeric pain
rating scale from baseline will be excluded from this study and will be counted as screen
failures; all others will be included in the study. The patient will then be provided an
appointment slip to meet the research team at the Army-Baylor Center for Rehabilitation
Research Biomechanics Lab at the Army Medical Department Center and School where all formal
testing for this study will take place. All laboratory data will be collected for the
bilateral lower extremities.
When the subject reports to the lab the following sequence will occur. They will be provided
with an intake form to collect all baseline data, Western Ontario and McMaster Universities
Osteoarthritis Index, and numeric pain rating score. Pain scores will be elicited throughout
the testing procedures to ensure patient safety and comfort per the PT service pain
assessment standard operating procedures. Pain pressure threshold will be obtained using a
handheld algometer as an adjunct to the numeric pain rating scale to better quantify their
pain levels. Pain pressure threshold measures will be collected bilaterally over the Tibialis
Anterior muscle belly approximately 2.5cm lateral and 5cm inferior to the tibial tubercle. A
Timed up and Go test will then be administered using an accelerometer worn by the patient
around the waist and bilaterally on the dorsum of the foot to quantify the velocity in which
they complete the test among the various phases (sit/stand, walking, turning). This will be
followed by the first isometric testing session to determine the baseline voluntary
quadriceps activation and rate of torque development.
Subjects will undergo assessment of neuromuscular function using a combination of voluntary
and evoked contractions. All test procedures will be performed on the unaffected limb first,
followed by the affected limb. Electrically-evoked contractile properties will be tested
first, followed by volitional strength, voluntary activation, then rate of torque
development.
Subjects will be seated on the chair for the HUMAC NORM testing and rehabilitation system
with the hips and knees flexed to 85 degrees and 60 degrees, respectively. A shin attachment
from the dynamometer will be secured around the subjects' lower leg so that the distal end of
the pad is approximately 5 cm proximal to the distal end of the tibia anteriorly.
Two-inch by four-inch self-adhesive muscle stimulation electrodes will be applied over the
muscle bellies of the distal vastus medialis and proximal vastus lateralis. Subjects will
then undergo evoked twitch contractions starting at 50mA (400 V, 1000 µsec pulse width) using
a constant current muscle and nerve stimulator (Digitimer Ltd., Model DS7R, Hertfordshire,
England) while sitting at rest. This process will continue until the evoked torque reaches a
plateau, at which point it will be terminated. The purpose of this testing is to determine
the lowest intensity of current necessary to evoke maximal quadriceps torque for each
subject. The amount of current necessary to achieve peak evoked twitch torque will be used
for all future evoked contractions. After this, muscle speed properties will be assessed
using 3 maximal twitches, followed by 3 maximal doublets at 100 Hz, all 10 seconds apart from
each other. This will be done for a total of 6 evoked contractions. The purpose of this is to
obtain information related to the peripheral speed properties of the muscle (e.g., rates of
rise and relaxation for torque).
Maximum volitional isometric contraction testing will be assessed next. Strength testing will
begin by having subjects perform 3 sub-maximal (50%, 75%, 90% maximum effort) isometric knee
extension contractions to familiarize themselves. After familiarization, subjects will
perform at least 2 maximal voluntary isometric contractions of the quadriceps muscles to
determine the peak voluntary knee extensor force each subject can generate. For reliability,
the researchers will require two contractions that produce similar values of torque (defined
as no more than 5% difference between trials). After peak torque has been reliably
identified, quadriceps activation will be tested with the interpolated doublet technique
(IDT).[30] This test includes at least two five second maximal voluntary isometric
contractions during which a doublet at the stimulus intensity determined in step one is
introduced when the torque produced by the subject reaches a threshold determined during
maximal voluntary isometric contraction testing. A second stimulus of equal intensity is
delivered shortly after the subject returns to rest after each trial in order to assess the
muscle in its potentiated state. Two minutes rest will be provided between each of the
trials. To produce inter-trial reliability similar to strength testing, the researchers will
require two contractions that produce similar values of voluntary activation (defined as no
more than 5% difference in voluntary activation between trials).
Rate of torque development will be measured after completion of maximal voluntary isometric
contraction trials. A total of five valid repetitions will be completed lasting approximately
one second in duration for each contraction. In order to count as a valid trial, the
magnitude of torque attained during these brief contractions must exceed 75% of maximal
voluntary isometric contraction. A rest period of 30 seconds between contractions will be
given in order to allow for adequate rest. An enthusiastic and loud verbal cue will be
provided for each contraction. Instructions to "kick as fast and as hard as possible" will be
utilized as verbal cues have been reported to impact the type of motion the patient conducts.
Visual feedback and loud verbal encouragement will be used to elicit the greatest amount of
muscle activation possible.
Treatment will be initiated within ten minutes of completing the first isometric trial within
the Army-Baylor Center for Rehabilitation Research. The researchers will utilize a pragmatic
manual physical therapy approach that is customized to each subject. This approach will use
targeted manual therapy techniques for the knee joint and soft tissues with complimentary
therapeutic exercises to augment the movement impairment identified. All treatment will be
performed by a board-certified physical therapist with advanced manual physical therapy
fellowship training. The treatment provided will be evidenced-based and is standard care for
a manual physical therapy trained provider. The timing of the treatment session is congruent
with what is commonly observed in a physical therapy clinic and will last approximately 30
minutes in duration.
The control group will receive the same amount of face-to-face time with a physical
therapist. The intervention will include a 30-minute educational class on knee osteoarthritis
which will cover various topics to include a brief description of the pathophysiology,
diagnosis, prognosis, and different treatment options available in addition to
rehabilitation. The researchers will provide handouts on general exercise and joint sparing
activities and conclude the brief with a question and answer session.
For post-treatment data collection, each subject will undergo testing for maximal voluntary
isometric contraction, voluntary activation, and rate of torque development in the same
manner as described above. For voluntary activation testing, the same stimulus intensity
determined during pre-treatment data collection will be used. In addition, subjects will not
require post-treatment assessment of the contractile properties of their quadriceps muscle
group. The reason for not repeating this assessment is because electrically-evoked
contractile properties quantify only peripheral physiologic properties of muscle and this
study's intent is to measure changes attributed to central drive (i.e. changes within the
motor cortex and/or spinal cord).
Immediately following the 30-minute treatment session, subjects will repeat the timed up and
go test and rate their pain via the numeric pain rating scale. Immediately following this,
the subject will undergo maximal voluntary isometric contraction testing, voluntary
activation, and rate of torque development testing in the same manner previously described.
The same stimulator settings used during the pre-test will be used for the post-test. At the
conclusion of data collection, the researchers will ensure the patient has a follow-up
appointment scheduled at the Brooke Army Medical Center physical therapy clinic for the
initiation of their formal rehabilitation, thus ensuring that all subjects receive the
standard of care for their knee pain. As all data will be collected on a single day in one
session no email or phone calls will be required at the completion of the lab testing.
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