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
NCT number | NCT04234282 |
Other study ID # | RTD_MVIC |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2020 |
Est. completion date | July 2020 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 74 Years |
Eligibility |
Inclusion Criteria: - Age range including 50-70 years old - Diagnosis of clinical and radiographic knee osteoarthritis (Altman's Criteria: knee pain, osteophytes and one of the following: crepitus with active motion, morning stiffness less than or equal to 30 minutes, bony enlargement) - Grade 2-4 Kellgren Lawrence radiographic knee osteoarthritis Able to tolerate maximal quadriceps isometric quadriceps contraction with the knee flexed to 60 degrees without pain increasing more than 3/10 points on the Numeric Pain rating scale 5 - English proficiency and cognition to understand explanations of research purpose and procedures - Tricare beneficiary Exclusion Criteria: - Knee pain referred from another anatomic region - Cardiovascular disease (limited to uncontrolled hypertension/arrhythmias as well as a pacemaker - Rheumatoid arthritis - Active cancer - BMI > 35 - Intra-articular knee injection within the previous 3 months - Traumatic knee injury or surgery in past 12months - Total knee or hip arthroplasty - Gait is limited to a greater extent by conditions other than knee osteoarthritis - Any condition that would contraindicate manual therapy or exercise - Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, active infection, or systemic disease - Known current pregnancy or history of pregnancy in the last 6 months - Separating from the military in the next 2 months, pending litigation, or pending medical board |
Country | Name | City | State |
---|---|---|---|
United States | Jennifer Moreno Clinic | Fort Sam Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Jennifer Moreno Clinic |
United States,
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16. Cobian, D.G., et al., Knee Extensor Rate of Torque Development Before and After Arthroscopic Partial Meniscectomy, With Analysis of Neuromuscular Mechanisms. 2017. 47(12): p. 945-956. 17. Folland, J., et al., Human capacity for explosive force production: neural and contractile determinants. 2014. 24(6): p. 894-906. 18. Jevsevar, D.S.J.J.-J.o.t.A.A.o.O.S., Treatment of osteoarthritis of the knee: evidence-based guideline. 2013. 21(9): p. 571-576. 19. Nussmeier, N.A., et al., Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. 2005. 352(11): p. 1081-1091. 20. SooHoo, N.F., et al., Factors predicting complication rates following total knee replacement. 2006. 88(3): p. 480-485.
21. Deyle, G.D., et al., Knee OA: which patients are unlikely to benefit from manual PT and exercise? 2012. 61(1): p. E1-8. 22. Deyle, G.D., et al., Effectiveness of manual physical therapy and exercise in osteoarthritis of the knee: a randomized, controlled trial. 2000. 132(3): p. 173-181. 23. Taylor, A.L., et al., Knee extension and stiffness in osteoarthritic and normal knees: a videofluoroscopic analysis of the effect of a single session of manual therapy. 2014. 44(4): p. 273-282. 24. Maitland, G.D., et al., Maitland's vertebral manipulation. Vol. 1. 2005: Elsevier Butterworth-Heinemann Philadelphia, PA. 25. Grindstaff, T.L., et al., Effects of lumbopelvic joint manipulation on quadriceps activation and strength in healthy individuals. Man Ther, 2009. 14(4): p. 415-20.
26. Suter, E., et al., Conservative lower back treatment reduces inhibition in knee-extensor muscles: a randomized controlled trial. J Manipulative Physiol Ther, 2000. 23(2): p. 76-80. 27. Yerys S, M.H., Byrd C, Pennachio J, Cinkay J, Effect of mobilization of the anterior hip capsule on gluteus maximus strength. Journal of Manual & Manipulative Therapy, 2002(10): p. 218-224 . 28. Makofsky H, P.S., Abbruzzese J, Aridas C, Camp M, Drakes J, Franco C, Sileo R, Immediate Effect of Grade IV Inferior Hip Joint Mobilization on Hip Abductor Torque: A Pilot Study. Journal of Manual & Manipulative Therapy, 2007. 15: p. 103-111. 29. Grindstaff, T.L., et al., Optimizing Between-Session Reliability for Quadriceps Peak Torque and Rate of Torque Development Measures. 2018. 30. Krishnan, C. and G.N. Williams, Quantification method affects estimates of voluntary quadriceps activation. Muscle Nerve, 2010. 41(6): p. 868-74.
36. Kean, C.O., et al., Minimal detectable change in quadriceps strength and voluntary muscle activation in patients with knee osteoarthritis. Arch Phys Med Rehabil, 2010. 91(9): p. 1447-51. 37. Park, G., et al., Reliability and usefulness of the pressure pain threshold measurement in patients with myofascial pain. 2011. 35(3): p. 412. 38. Walton, D., et al., Reliability, standard error, and minimum detectable change of clinical pressure pain threshold testing in people with and without acute neck pain. 2011. 41(9): p. 644-650.
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Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70. doi: 10.1002/acr.20538. Review. — View Citation
Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Torque Development | The between-session reliability for quadriceps peak torque (ICC2,3 = 0.98) has been shown to be optimized by performing five repetitions and using the average of the three repetitions with the highest isometric peak torque with a 30 second rest period between contractions. The minimal detectable change for healthy controls is reported as 265.4 Nm/s with a standard deviation of 112.8 Nm/s.[29] | 3 hours | |
Primary | Voluntary Quadriceps Activation | This variable will be calculated utilizing the interpolated twitch technique by superimposing an electrical stimulus to quadriceps maximum volitional isometric contraction and using the same stimulus applied at rest. Interpolated twitch technique is an accurate method to calculate voluntary quadriceps activation.[30, 35] | 3 hours | |
Secondary | Numeric Pain Rating Scale | The Numeric Pain Rating Scale is a self-reported 11-point scale from 0-10 for pain intensity, which has been shown to be sensitive to change and has been shown to be valid and reliable for patients with chronic pain. The minimally clinically important difference has been reported as 2 on this scale. | 3 hours | |
Secondary | Timed Up and Go Test | The Timed Up and Go test has been shown to be sensitive to small changes in functional status and may be a good indicator to measure the progress of rehabilitation interventions. The decrease in time to conduct the Timed Up and Go Test by as little as .8 seconds has been associated with improved Global Rating of Change scores of +5. This measure has been shown to be reliable and is a good indicator of physical mobility in older frail adults. [33] | 3 hours |
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