Short-term and Intermediate-term Effects of Self-applied Joint Mobilization Versus Clinician-applied Joint Mobilization in Addition to Exercise in Patients With Knee Osteoarthritis: A Randomized Clinical Trial

Study Purpose

The goal of this clinical trial is to learn if a combination of patient self-administered joint mobilization and exercise works to treat knee osteoarthritis in adults. The main questions it aims to answer are:

  • - Does self-administered joint mobilization improve the ability to perform regular daily activities? - Does self-administered joint mobilization improve knee motion? - Does self-administered joint mobilization improve hip strength? Researchers will compare the program of self-administered joint mobilization to a joint mobilization administered by a physical therapist.
Participants will:
  • - Attend 8-12 physical therapy clinic visits over 6 - 8 weeks.
  • - Perform home exercises.
- Visit the clinic 6 months later for a brief check-up

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 45 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Meets National Institute for Health and care Excellence (NICE) criteria for knee osteoarthritis: - Age 45 years or older.
  • - Movement-related knee pain.
  • - No morning stiffness or morning stiffness < 30 minutes.
  • - Knee flexion contracture (kFC) at least 1cm, measured by heel-height.
  • - Fluency in verbal and written English for completion of outcome measure and screening, and to take directions.
  • - Able to attend all study-related appointments.

Exclusion Criteria:

  • - Assistive device required for ambulation.
  • - Systemic disease affecting joint function (diabetes, rheumatological disorders, etc) - Previous lower extremity joint replacement.
  • - Lower quarter surgery, injection, or therapy in the past year.
  • - Other functionally-limiting physical impairment of the lower quarter.
- Spine or lower extremity compensation claim (work, accident, etc)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07020897
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Texas Woman's University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Guy L Terry, MPT, PhD(c)
Principal Investigator Affiliation Texas Woman's University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Osteoarthritis
Additional Details

This study will take place in the Outpatient Rehabilitation Clinic at Texas Health Resources (THR) in Plano, or in the Texas Health Sports Medicine Clinic in Allen. Participants in this study will be asked to complete the same intake forms and questionnaires as any other physical therapy patient being seen for knee pain at all of the THR physical therapy clinics. These will include questions about health history, learning style, living situation, and goals for physical therapy treatment. One investigator will perform a physical therapy evaluation, including joint motion, muscle strength, and flexibility measurements, as well as functional testing. For this study, we will measure one knee motion and one hip strength item and ask participants to complete a knee- specific questionnaire 3 times: on the initial evaluation visit, during the last visit of physical therapy, and during a 6-month follow-up visit. After the initial evaluation visit, we will assign each participant into one of the two treatment groups, self-joint mobilization or joint mobilization performed by a physical therapist. Participants will be asked to attend 7

  • - 11 physical therapy treatment visits over 7-8 weeks for strength training exercises, flexibility exercises, joint mobilization, and a home exercise program.
Each physical therapy visit, including the initial evaluation visit will last 45 minutes. Participants will be asked to track compliance with a home program and attend a follow-up appointment about 6 months after the initial evaluation. This follow-up visit will last about 30 minutes. All appointments, except for the 6-month follow-up, will be structured and carried out as they would for any other patient receiving physical therapy for knee pain.

Arms & Interventions

Arms

Active Comparator: Clinician-administered joint mobilization

In-clinic exercise-based physical therapy, home exercise program, and clinician-administered joint mobilization.

Experimental: Self-administered joint mobilization

In-clinic exercise-based physical therapy, home exercise program, and self-administered joint mobilization.

Interventions

Other: - Clinician-administered joint mobilization

Tibiofemoral arthrokinematic extension joint mobilization and multidirectional patellofemoral mobilization applied by a physical therapist.

Other: - Self-administered joint mobilization

Tibiofemoral arthrokinematic extension joint mobilization and multidirectional patellofemoral mobilization applied by the research participant.

Other: - Exercise-based physical therapy

In-clinic exercise-based physical therapy supervised by a physical therapist, with home exercises to be performed on days without a clinical visit.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Allen, Texas

Status

Address

Texas Health Resources Sports Medicine Allen

Allen, Texas, 75013

Site Contact

Guy L Terry, MPT, PhD(c)

[email protected]

972-939-6501

Plano, Texas

Status

Address

Texas Health Resources Plano Presbyterian Outpatient Rehabilitation

Plano, Texas, 75093

Site Contact

Guy L Terry, MPT, PhD(c)

[email protected]

972-939-6501