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

NCT04234282 | Unknown DMC

• 1 other identifier: RTD_MVIC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis; Knee Arthritis; Knee Pain Chronic; Knee Deformity; Knee Pain Swelling; Muscle Weakness; Muscle Weakness Condition; Power

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Numeric Pain Rating Scale

  3 hours

• Timed Up and Go Test

  3 hours

Study Arms (2)

Control Group

NO INTERVENTION

The control group will receive a 30-minute class on knee osteoarthritis diagnosis, prognosis, various treatment options, and will conclude with a question and answer session. This will account for the 30 minute face to face time provided in the treatment group

Manual Physical Therapy

EXPERIMENTAL

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 manual therapy and exercises are tailored to the individual based on their limitations and restrictions.

Procedure: Manual Physical Therapy

Interventions

Manual Physical Therapy PROCEDURE

Orthopedic manual physical therapy targeting the knee joint and soft tissues with complementary exercises targeted at their impairment.

Also known as: Joint Mobilization, Joint Manipulation

Manual Physical Therapy

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• English proficiency and cognition to understand explanations of research purpose and procedures
• Tricare beneficiary

You may not qualify if:

• 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

Sponsors & Collaborators

• Jennifer Moreno Clinic: lead

Study Sites (1)

Jennifer Moreno Clinic

Fort Sam Houston, Texas, 78234, United States

RECRUITING

Related Publications (9)

• 1. Showery, J.E., et al., The rising incidence of degenerative and posttraumatic osteoarthritis of the knee in the United States military. 2016. 31(10): p. 2108-2114. 2. Armed, F.H.S.B.J.M., Absolute and relative morbidity burdens attributable to various illnesses and injuries, non-service member beneficiaries of the Military Health System, 2017. 2018. 25(5): p. 32. 3. Zhang, Y. and J.M.J.C.i.g.m. Jordan, Epidemiology of osteoarthritis. 2010. 26(3): p. 355-369. 4. Milley, M.A.J.U.S.A., 39th Chief of Staff initial message to the army. 2015. 5. Anwer, S., et al., Effects of orthopaedic manual therapy in knee osteoarthritis: a systematic review and meta-analysis. 2018.

  BACKGROUND

• 11. Fitzgerald, G.K., et al., Quadriceps activation failure as a moderator of the relationship between quadriceps strength and physical function in individuals with knee osteoarthritis. Arthritis Rheum, 2004. 51(1): p. 40-8. 12. Petterson, S.C., et al., Mechanisms undlerlying quadriceps weakness in knee osteoarthritis. 2008. 40(3): p. 422. 13. Rice, D.A., et al., Mechanisms of quadriceps muscle weakness in knee joint osteoarthritis: the effects of prolonged vibration on torque and muscle activation in osteoarthritic and healthy control subjects. 2011. 13(5): p. R151. 14. Rice, D.A. and P.J. McNair. Quadriceps arthrogenic muscle inhibition: neural mechanisms and treatment perspectives. in Seminars in arthritis and rheumatism. 2010. Elsevier. 15. Maffiuletti, N.A., et al., Rate of force development: physiological and methodological considerations. 2016. 116(6): p. 1091-1116.

  BACKGROUND

• 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.

  BACKGROUND

• 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. No abstract available.

  PMID: 22588748 BACKGROUND

• 6. Øiestad, B., et al., Knee extensor muscle weakness is a risk factor for development of knee osteoarthritis. A systematic review and meta-analysis. 2015. 23(2): p. 171-177. 7. Felson, D.T., et al., The prevalence of knee osteoarthritis in the elderly. The Framingham Osteoarthritis Study. 1987. 30(8): p. 914-918. 8. Vina, E.R. and C.K. Kwoh, Epidemiology of osteoarthritis: literature update. Curr Opin Rheumatol, 2018. 30(2): p. 160-167. 9. Guccione, A.A., et al., The effects of specific medical conditions on the functional limitations of elders in the Framingham Study. Am J Public Health, 1994. 84(3): p. 351-8. 10. Slemenda, C., et al., Quadriceps weakness and osteoarthritis of the knee. Ann Intern Med, 1997. 127(2): p. 97-104.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Kean CO, Birmingham TB, Garland SJ, Bryant DM, Giffin JR. Minimal detectable change in quadriceps strength and voluntary muscle activation in patients with knee osteoarthritis. Arch Phys Med Rehabil. 2010 Sep;91(9):1447-51. doi: 10.1016/j.apmr.2010.06.002.

  PMID: 20801266 BACKGROUND

• 33. Podsiadlo, D. and S.J.J.o.t.A.g.S. Richardson, The timed "Up & Go": a test of basic functional mobility for frail elderly persons. 1991. 39(2): p. 142-148. 34. Bennell, K., et al., 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. 2011. 63(S11): p. S350-S370. 35. Zarkou, A., et al., Comparison of techniques to determine human skeletal muscle voluntary activation. J Electromyogr Kinesiol, 2017. 36: p. 8-15.

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Muscle Weakness

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Matthew S Helton, DPT

  Orthopedic PT Fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew S Helton, DPT

CONTACT

828-851-6830; matthew.s.helton2.mil@mail.mil

Bryan B Pickens, DSc

CONTACT

210-808-2226; bryan.b.pickens.mil@mail.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patient will be randomly assigned using a random number generator to either the control or treatment group. The investigator and outcome assessor will not be present when the patient is receiving the control or treatment interventions. Pt will be instructed not to reveal which group they were assigned to when tested by the blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic and Manual Physical Therapy Fellow

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: January 21, 2020
• Study Start: January 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 21, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The informed consent document will be kept for 3 years.
• Access Criteria: Orthopedic Manual Physical Therapy Fellowship Director or Fellow

Locations

US (1)