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

NCT07020897 | Not Yet Recruiting

• 1 other identifier: IRB-FY2025-156
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Knee flexion contracture; Knee osteoarthritis; Joint mobilization; Physical therapy; Hip abductor strength

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Arthritis Index (WOMAC)

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

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

Secondary Outcomes (2)

• Hip abductor strength

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

• Passive knee extension range of motion

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

Study Arms (2)

Clinician-administered joint mobilization

ACTIVE COMPARATOR

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

Other: Clinician-administered joint mobilization; Other: Exercise-based physical therapy

Self-administered joint mobilization

EXPERIMENTAL

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

Other: Self-administered joint mobilization; Other: Exercise-based physical therapy

Interventions

Clinician-administered joint mobilization OTHER

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

Clinician-administered joint mobilization

Self-administered joint mobilization OTHER

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

Self-administered joint mobilization

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.

Clinician-administered joint mobilization; Self-administered joint mobilization

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Texas Woman's University: lead
• Texas Health Resources: collaborator

Study Sites (2)

Texas Health Resources Sports Medicine Allen

Allen, Texas, 75013, United States

Location

Texas Health Resources Plano Presbyterian Outpatient Rehabilitation

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Guy L Terry, MPT, PhD(c)

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy L Terry, MPT, PhD(c)

CONTACT

972-939-6501; gterry@twu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)