Osteoarthritis, KneeNCT06080763
Biomechanics and Clinical Outcomes in Responders and Non-Responders
An observational study of Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Mahidol University at 2 sites in Thailand.
Trial summary
Knee osteoarthritis is a degenerative joint disease that affects many older adults. However, not all patients see improvements as a result of physical therapy management; therefore, a better understanding of biomechanics and assessment of clinical outcomes between responders and non-responders is required. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Arthroplasty, Replacement, Knee, Physical Therapy
- What is being tested?
- Physical Therapy Management
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 2 sitesThailand
- Study dates
- 5 Sep 2023to Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with knee osteoarthritis who are currently receiving physical therapy management at Mahidol University's Physical Therapy Center
Who may be able to join
- Diagnosis of knee osteoarthritis based on American College of Rheumatology
- Pain intensity of ≥ 4 out of 10 at the pre-treatment day
- Ability to walk for at least six meters without an assistive device
Who cannot join
- History of previous lower limb surgery, such as total hip replacement
- History of neurological disorder, such as stroke
- History of vestibular disease, such as Meniere's disease
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Physical Therapy Center, Mahidol University
Bangkok, Bang Phlat, 10700
Komsak Sinsurin, Ph.D., +66 024415450 ext. 20605, komsak.sin@mahidol.edu
Phunsuk Kantha, Ph.D., +66 0932951646, phunsuk.kan@mahidol.ac.th
- Recruiting
Faculty of Physical Therapy, Mahidol University
Nakhon Pathom, Salaya, 73170
Komsak Sinsurin, Ph.D., +66 024415450 ext. 20605, komsak.sin@mahidol.edu
Phunsuk Kantha, Ph.D., +66 0932951646, phunsuk.kan@mahidol.ac.th
About this study
Official title: Exploring Biomechanics and Clinical Outcomes in Responders and Non-Responders to Physical Therapy Management for Knee Osteoarthritis
Knee osteoarthritis is a degenerative joint disease that affects many older adults. However, not all patients see improvements as a result of physical therapy management; therefore, a better understanding of biomechanics and assessment of clinical outcomes between responders and non-responders is required.
The included participants will be provided with informed consent and an explanation of the study procedure before enrolling in data collection. The data collection will be arranged in the same order. Practice trials will be provided before the start of data collection. The data collection will consist of standardized questionnaires, assessments, and tests commonly used in clinics.
Read the detailed description
During data collection, markerless motion capture systems will be placed around the area of interest. The markerless system does not require markers to be attached to the participant's body.
The data collection will include:
- Demographic information such as age, sex, body height, body weight, body mass index, medical history, medical diagnosis, and the Kellgren-Lawrence score.
- Patient-reported questionnaires such as the numeric pain rating scale, knee injury and osteoarthritis outcome score, Western Ontario and McMaster Universities Osteoarthritis, and Depression, Anxiety, and Stress Scale - 21 Items.
- Clinical assessments such as the Varus-valgus laxity test, Foot posture index, Range of motion, Muscle flexibility, and Muscle strength.
- Functional tests such as the Timed up and go test, Five times sit-to-stand test, Four-meter walk test, and Bipedal quiet stance test.
- Being tested
- Physical Therapy Management
- Keywords
- Biomechanics, Assessment, Outcomes
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy ManagementProcedure or surgery
Physical therapy management is a routine intervention provided by physical therapists at Mahidol University's Physical Therapy Center for individuals with knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Non-Responders | Individuals who do not respond to physical therapy are determined by the absence of significant improvements, with no change in pain or function exceeding 50%, and with an absolute change of less than 20%. Receives: Procedure: Physical Therapy Management | |
| Responders | Individuals who respond to physical therapy are determined by the presence of significant improvements, with changes in pain or function exceeding 50%, and with an absolute change of more than 20%. Receives: Procedure: Physical Therapy Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
The pain intensity will be measured using a numeric rating scale from 0 to 10, with 0 indicating no pain and 10 representing the worst pain imaginable.
Measured: Pain intensity will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Knee Injury and Osteoarthritis Outcome Score
The Knee Injury and Osteoarthritis Outcome Score is a questionnaire designed to assess participants' perceptions of their knee severity in various contexts. This questionnaire comprises 42 items that evaluate the participant's perception of pain, stiffness, function, and other knee-related symptoms. Each item is rated on a five-point Likert scale, with 0 indicating no problem and 4 indicating extreme problems. The total score will be transformed to range from 0 to 100 percent.
Measured: Knee injury and osteoarthritis outcome score will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Western Ontario and McMaster Universities Osteoarthritis
The Western Ontario and McMaster Universities Osteoarthritis is a questionnaire to assesses the level of pain, stiffness, and physical functioning in individuals with knee osteoarthritis. The questionnaire consists of 24 items that are divided into three subscales: 1) pain (5 items); 2) stiffness (2 items); and 3) physical function (17 items). Each item is rated on a five-point Likert scale, with 0 indicating no pain or difficulty and 4 indicating extreme pain or difficulty. The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function.
Measured: Western Ontario and McMaster Universities Osteoarthritis will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Depression, Anxiety and Stress Scale - 21 Items
The Depression, Anxiety and Stress Scale - 21 Items is a self-report questionnaire designed to measure the severity of symptoms related to depression, anxiety, and stress. It consists of 21 items, with seven items dedicated to each of the three domains: 1) depression (7 items); 2) anxiety (7 items); and 3) stress (7 items). Each item is scored on a four-point Likert scale, with 0 indicating that the symptom is not present and 3 indicating that the symptom is severe. The scores for each domain are summed and then multiplied by two, resulting in a possible score range of 0-42 for depression, 0-42 for anxiety, and 0-42 for stress.
Measured: Depression, Anxiety and Stress Scale - 21 Items will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Varus-valgus laxity score
The varus-valgus laxity test is an assessment used to evaluate the stability of the knee joint. Laxity will be graded based on the amount of medial movement observed: 0 for no movement, 1 for slight medial movement of 5-10 mm, and 2 for substantial medial movement greater than 10 mm. The score will range from 0 to 2.
Measured: Varus-valgus laxity score will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Foot posture index
The foot posture index is an assessment used to evaluate the posture of the foot and identify any deviations from normal alignment. The foot posture index involves the evaluation of six different aspects of foot posture: 1) talar head palpation; 2) supra and inferolateral malleolar curvature; 3) calcaneal eversion/inversion; 4) bulge in the region of the talonavicular joint; 5) height and congruence of the medial longitudinal arch; and 6) abduction/adduction of the forefoot. Each aspect is scored on a scale ranging from -2 to +2, with 0 representing a neutral or "normal" position. The final score ranges from -12 to +12. A more negative number indicates a supinated foot, while a more positive number indicates a pronated foot.
Measured: Foot posture index will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Muscle flexibility
The muscle flexibility is used to evaluate the ability of muscles to lengthen. The flexibility of the quadriceps, hamstring, and gastrocnemius will be measured. The results will be reported in degrees.
Measured: Muscle flexibility will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Range of motion
Range of motion is used to evaluate joint mobility during active movement. The range of motion for the hip, knee, and ankle joints will be measured. The results will be reported in degrees.
Measured: Range of motion will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Muscle strength
Muscle strength is used to evaluate the maximum force generated by muscles. The strength of the hip extensor, hip abductor, and knee extensor will be measured. The results will be reported in newtons.
Measured: Muscle strength will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Joint kinematics
Joint kinematics is used to evaluate the movement of the trunk, hip, and knee joints during functional tests such as the Timed Up and Go Test, Five Times Sit-to-Stand Test, Four-Meter Walk Test, and Bipedal Quiet Stance Test. The results will be reported in degrees per second.
Measured: Joint kinematics will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start5 Sep 2023
- Primary completionJan 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Komsak Sinsurin, Mahidol University
- Investigators
- Komsak Sinsurin, Ph.D., Principal investigator, Biomechanics and Sports Research unit, Faculty of Physical Therapy, Mahidol UniversityPhunsuk Kantha, Ph.D., Principal investigator, Faculty of Physical Therapy, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080763
- Sponsor's protocol ID
- MU-CIRB 2023/117.1108
- Status last verified
- Mar 2024
- First submitted
- 22 Sep 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Biomechanics and Clinical Outcomes in Responders and Non-Responders to Physical Therapy Management for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06080763
- Acronym / sponsor ID
- MU-CIRB 2023/117.1108
- Keywords
- Biomechanics, Assessment, Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Oct 2023 (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.
Knee osteoarthritis is a degenerative joint disease that affects many older adults. However, not all patients see improvements as a result of physical therapy management; therefore, a better understanding of biomechanics and assessment of clinical outcomes between responders and non-responders is required.
The included participants will be provided with informed consent and an explanation of the study procedure before enrolling in data collection. The data collection will be arranged in the same order. Practice trials will be provided before the start of data collection. The data collection will consist of standardized questionnaires, assessments, and tests commonly used in clinics.
Detailed description
During data collection, markerless motion capture systems will be placed around the area of interest. The markerless system does not require markers to be attached to the participant's body.
The data collection will include:
- Demographic information such as age, sex, body height, body weight, body mass index, medical history, medical diagnosis, and the Kellgren-Lawrence score.
- Patient-reported questionnaires such as the numeric pain rating scale, knee injury and osteoarthritis outcome score, Western Ontario and McMaster Universities Osteoarthritis, and Depression, Anxiety, and Stress Scale - 21 Items.
- Clinical assessments such as the Varus-valgus laxity test, Foot posture index, Range of motion, Muscle flexibility, and Muscle strength.
- Functional tests such as the Timed up and go test, Five times sit-to-stand test, Four-meter walk test, and Bipedal quiet stance test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Responders | – | Procedure: Physical Therapy ManagementIndividuals who do not respond to physical therapy are determined by the absence of significant improvements, with no change in pain or function exceeding 50%, and with an absolute change of less than 20%. |
| Responders | – | Procedure: Physical Therapy ManagementIndividuals who respond to physical therapy are determined by the presence of significant improvements, with changes in pain or function exceeding 50%, and with an absolute change of more than 20%. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with knee osteoarthritis who are currently receiving physical therapy management at Mahidol University's Physical Therapy Center
Key inclusion criteria (3 listed)
- Diagnosis of knee osteoarthritis based on American College of Rheumatology
- Pain intensity of ≥ 4 out of 10 at the pre-treatment day
- Ability to walk for at least six meters without an assistive device
Key exclusion criteria (3 listed)
- History of previous lower limb surgery, such as total hip replacement
- History of neurological disorder, such as stroke
- History of vestibular disease, such as Meniere's disease
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 |
|---|---|---|
| Physical Therapy ManagementPhysical therapy management is a routine intervention provided by physical therapists at Mahidol University's Physical Therapy Center for individuals with knee osteoarthritis. | Procedure or surgery | Non-Responders, Responders |
Primary outcome
Pain intensity
Time frame: Pain intensity will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
The pain intensity will be measured using a numeric rating scale from 0 to 10, with 0 indicating no pain and 10 representing the worst pain imaginable.
Knee Injury and Osteoarthritis Outcome Score
Time frame: Knee injury and osteoarthritis outcome score will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
The Knee Injury and Osteoarthritis Outcome Score is a questionnaire designed to assess participants' perceptions of their knee severity in various contexts. This questionnaire comprises 42 items that evaluate the participant's perception of pain, stiffness, function, and other knee-related symptoms. Each item is rated on a five-point Likert scale, with 0 indicating no problem and 4 indicating extreme problems. The total score will be transformed to range from 0 to 100 percent.
Western Ontario and McMaster Universities Osteoarthritis
Time frame: Western Ontario and McMaster Universities Osteoarthritis will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
The Western Ontario and McMaster Universities Osteoarthritis is a questionnaire to assesses the level of pain, stiffness, and physical functioning in individuals with knee osteoarthritis. The questionnaire consists of 24 items that are divided into three subscales: 1) pain (5 items); 2) stiffness (2 items); and 3) physical function (17 items). Each item is rated on a five-point Likert scale, with 0 indicating no pain or difficulty and 4 indicating extreme pain or difficulty. The scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function.
Depression, Anxiety and Stress Scale - 21 Items
Time frame: Depression, Anxiety and Stress Scale - 21 Items will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
The Depression, Anxiety and Stress Scale - 21 Items is a self-report questionnaire designed to measure the severity of symptoms related to depression, anxiety, and stress. It consists of 21 items, with seven items dedicated to each of the three domains: 1) depression (7 items); 2) anxiety (7 items); and 3) stress (7 items). Each item is scored on a four-point Likert scale, with 0 indicating that the symptom is not present and 3 indicating that the symptom is severe. The scores for each domain are summed and then multiplied by two, resulting in a possible score range of 0-42 for depression, 0-42 for anxiety, and 0-42 for stress.
Varus-valgus laxity score
Time frame: Varus-valgus laxity score will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
The varus-valgus laxity test is an assessment used to evaluate the stability of the knee joint. Laxity will be graded based on the amount of medial movement observed: 0 for no movement, 1 for slight medial movement of 5-10 mm, and 2 for substantial medial movement greater than 10 mm. The score will range from 0 to 2.
Foot posture index
Time frame: Foot posture index will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
The foot posture index is an assessment used to evaluate the posture of the foot and identify any deviations from normal alignment. The foot posture index involves the evaluation of six different aspects of foot posture: 1) talar head palpation; 2) supra and inferolateral malleolar curvature; 3) calcaneal eversion/inversion; 4) bulge in the region of the talonavicular joint; 5) height and congruence of the medial longitudinal arch; and 6) abduction/adduction of the forefoot. Each aspect is scored on a scale ranging from -2 to +2, with 0 representing a neutral or "normal" position. The final score ranges from -12 to +12. A more negative number indicates a supinated foot, while a more positive number indicates a pronated foot.
Muscle flexibility
Time frame: Muscle flexibility will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
The muscle flexibility is used to evaluate the ability of muscles to lengthen. The flexibility of the quadriceps, hamstring, and gastrocnemius will be measured. The results will be reported in degrees.
Range of motion
Time frame: Range of motion will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Range of motion is used to evaluate joint mobility during active movement. The range of motion for the hip, knee, and ankle joints will be measured. The results will be reported in degrees.
Muscle strength
Time frame: Muscle strength will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Muscle strength is used to evaluate the maximum force generated by muscles. The strength of the hip extensor, hip abductor, and knee extensor will be measured. The results will be reported in newtons.
Joint kinematics
Time frame: Joint kinematics will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.
Joint kinematics is used to evaluate the movement of the trunk, hip, and knee joints during functional tests such as the Timed Up and Go Test, Five Times Sit-to-Stand Test, Four-Meter Walk Test, and Bipedal Quiet Stance Test. The results will be reported in degrees per second.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Komsak Sinsurin, Ph.D. principal investigator
Biomechanics and Sports Research unit, Faculty of Physical Therapy, Mahidol University
Phunsuk Kantha, Ph.D. principal investigator
Faculty of Physical Therapy, Mahidol University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Mahidol University at 2 sites in Thailand.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Mar 2024. 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Komsak Sinsurin, Ph.D. (+66 024415450 ext. 20605, komsak.sin@mahidol.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Pain intensity will be measured at four time points (i.e., pre-treatment, 6-sessions treatment, 12-sessions treatment, and 18-sessions treatment) spanning up to 6 months.). The study lists 10 primary outcomes in all. 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 15 Mar 2024.