Recruiting

Manual Physical Therapy

Sponsor:

Jennifer Moreno Clinic

Code:

NCT04234282

Conditions

Knee Osteoarthritis

Knee Arthritis

Knee Pain Chronic

Knee Deformity

Knee Pain Swelling

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

Interventions

Manual Physical Therapy

Study Details

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

Study ID

NCT04234282

Start date

Jan, 2020

Status verified date

Jan, 2020

Completion date

Jul, 2020

Anticipated

Primary completion date

May, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Group

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

experimental: Manual Physical Therapy

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.

Interventions

Manual Physical Therapy

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

Primary outcome measure

  • Rate of Torque Development [ Time Frame: 3 hours ]
  • Voluntary Quadriceps Activation [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Locations

Jennifer Moreno Clinic

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

More Information

Sponsor

Jennifer Moreno Clinic

Last update posted

Jan 21, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jennifer Moreno Clinic on 2020-01-21.