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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rate of Torque Development
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of Torque Development
时间窗: 3 hours
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.\[29\]
Voluntary Quadriceps Activation
时间窗: 3 hours
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.\[30, 35\]
次要结局
- Numeric Pain Rating Scale(3 hours)
- Timed Up and Go Test(3 hours)
研究者
MAJ Matthew Helton
Orthopedic and Manual Physical Therapy Fellow
Jennifer Moreno Clinic