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NCT Number: NCT07020897

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

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

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Texas Health Resources Sports Medicine Allen, Allen, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clinician-administered joint mobilization

Other

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

Self-administered joint mobilization

Other

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

Exercise-based physical therapy

Other

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

Primary outcomes

  1. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: Baseline (enrollment), 6-8 weeks (end of physical therapy sessions), 6 months

    The WOMAC is a self-administered questionnaire assessing pain, stiffness, and physical function in patients with knee osteoarthritis.

Secondary outcomes

  1. Hip abductor strength

    Time frame: Baseline (enrollment), 6-8 weeks (end of physical therapy sessions), 6 months

    Hip abductor strength measured by hand-held dynamometer

  2. Passive knee extension range of motion

    Time frame: Baseline (enrollment), 6-8 weeks (end of in-clinic physical therapy), 6 months

    Passive knee extension range of motion will be measured in supine with traditional goniometry and in prone with a heel-height measurement.

Study contacts

Contact information is provided by the study sponsor or research team.

Guy L Terry, MPT, PhD(c)

CONTACT

[email protected]

972-939-6501

Sponsors and collaborators

Lead sponsor

Texas Woman's University

Other

Collaborators

  • Texas Health Resources

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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