Knee OsteoarthritisNCT07020897
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
A study testing Clinician-administered joint mobilization, Self-administered joint mobilization and Exercise-based physical therapy in people with Knee Osteoarthritis, run by Texas Woman's University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Clinician-administered joint mobilization, Self-administered joint mobilization and Exercise-based physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Texas Health Resources Sports Medicine Allen
Allen, Texas, 75013
Guy L Terry, MPT, PhD(c), 972-939-6501, gterry@twu.edu
Texas Health Resources Plano Presbyterian Outpatient Rehabilitation
Plano, Texas, 75093
Guy L Terry, MPT, PhD(c), 972-939-6501, gterry@twu.edu
About this study
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?
Read more
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
Read the detailed description
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Clinician-administered joint mobilization, Self-administered joint mobilization, Exercise-based physical therapy
- Keywords
- Knee flexion contracture, Knee osteoarthritis, Joint mobilization, Physical therapy, Hip abductor strength
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician-administered joint mobilizationOther
Tibiofemoral arthrokinematic extension joint mobilization and multidirectional patellofemoral mobilization applied by a physical therapist.
Self-administered joint mobilizationOther
Tibiofemoral arthrokinematic extension joint mobilization and multidirectional patellofemoral mobilization applied by the research participant.
Exercise-based physical therapyOther
In-clinic exercise-based physical therapy supervised by a physical therapist, with home exercises to be performed on days without a clinical visit.
| Study group | Role | What they receive |
|---|---|---|
| Clinician-administered joint mobilization | Active comparator | In-clinic exercise-based physical therapy, home exercise program, and clinician-administered joint mobilization. Receives: 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. Receives: Other: Self-administered joint mobilization; Other: Exercise-based physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (enrollment), 6-8 weeks (end of physical therapy sessions), 6 months
Secondary outcomes (2)
Hip abductor strength
Hip abductor strength measured by hand-held dynamometer
Measured: Baseline (enrollment), 6-8 weeks (end of physical therapy sessions), 6 months
Passive knee extension range of motion
Passive knee extension range of motion will be measured in supine with traditional goniometry and in prone with a heel-height measurement.
Measured: Baseline (enrollment), 6-8 weeks (end of in-clinic physical therapy), 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start15 Jul 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Health Resources
- Responsible party
- Sponsor
- Investigators
- Guy L Terry, MPT, PhD(c), Principal investigator, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020897
- Sponsor's protocol ID
- IRB-FY2025-156
- Status last verified
- Apr 2025
- First submitted
- 5 Jun 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing IPD raises ethical concerns about participant privacy and the potential for misuse of sensitivity data. Data protection laws and regulations can restrict the sharing of personal data, even for research purposes.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07020897
- Acronym / sponsor ID
- IRB-FY2025-156
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee flexion contracture, Knee osteoarthritis, Joint mobilization, Physical therapy, Hip abductor strength
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Collaborators
- Texas Health Resources
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinician-administered joint mobilization | Active comparator | Other: Clinician-administered joint mobilization, Other: Exercise-based physical therapyIn-clinic exercise-based physical therapy, home exercise program, and clinician-administered joint mobilization. |
| Self-administered joint mobilization | Experimental | Other: Self-administered joint mobilization, Other: Exercise-based physical therapyIn-clinic exercise-based physical therapy, home exercise program, and self-administered joint mobilization. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician-administered joint mobilizationTibiofemoral arthrokinematic extension joint mobilization and multidirectional patellofemoral mobilization applied by a physical therapist. | Other | Clinician-administered joint mobilization |
| Self-administered joint mobilizationTibiofemoral arthrokinematic extension joint mobilization and multidirectional patellofemoral mobilization applied by the research participant. | Other | Self-administered joint mobilization |
| Exercise-based physical therapyIn-clinic exercise-based physical therapy supervised by a physical therapist, with home exercises to be performed on days without a clinical visit. | Other | Clinician-administered joint mobilization, Self-administered joint mobilization |
Primary outcome
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.
2 secondary outcomes
Hip abductor strength
Time frame: Baseline (enrollment), 6-8 weeks (end of physical therapy sessions), 6 months
Passive knee extension range of motion
Time frame: Baseline (enrollment), 6-8 weeks (end of in-clinic physical therapy), 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No. Sharing IPD raises ethical concerns about participant privacy and the potential for misuse of sensitivity data. Data protection laws and regulations can restrict the sharing of personal data, even for research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guy L Terry, MPT, PhD(c) principal investigator
Texas Woman's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician-administered joint mobilization, Self-administered joint mobilization and Exercise-based physical therapy in people with Knee Osteoarthritis, run by Texas Woman's University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guy L Terry, MPT, PhD(c) (972-939-6501, gterry@twu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: Baseline (enrollment), 6-8 weeks (end of physical therapy sessions), 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.