Osteoarthritis, KneeNCT03628508
Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis
A study testing Exercise in people with Osteoarthritis, Knee, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older adults. It poses great challenge to the health care system due to its inability to be cured. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 50-80
- having radiographic tibiofemoral joint OA in the medial compartment defined as Kellgren and Lawrence grade = 2 to 3
- having medial knee pain on most days of the month
- having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking
Who cannot join
- having lateral tibiofemoral compartment osteophytes greater than the medial side.
- having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months
- having a systemic arthritic condition (e.g., rheumatoid arthritis)
- having a knee joint replacement or high tibial osteotomy in the past
- having any other muscular, joint or neurological condition influencing lower limb function
- unable to walk unaided
- having low back, hip, ankle or foot pain > 3 on numerical rating scale
- having a body mass index (BMI) >36 kg/ m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Tibia Torsion and Passive Muscle Stiffness of Quadriceps as Two Important Contributors of Joint Loading During Walking in People With Knee Osteoarthritis
Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older adults. It poses great challenge to the health care system due to its inability to be cured. Understanding factors associated with disease progression in KOA should assist the development of novel prevention/rehabilitation strategies. This study investigate factors including muscle properties, lower limb alignment and joint loading in patients with knee osteoarthritis before and after a six-week exercise program.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Exercise
- Keywords
- muscle tension, alignment, knee osteoarthritis, loading
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Comprehensive exercise program including strengthening, stretching, gait modification etc.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Six-week exercise including stretching, strengthening, endurance and gait modification Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System
External knee moment in the frontal plane during early stance phase of walking
Measured: At baseline and one week after intervention
Secondary outcomes (3)
Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score
Pain intensity measured by the pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS). The minimum value is 0 and maximum value is 100. The higher scores mean a better outcome.
Measured: At baseline and one week after intervention
Tibial Torsion as Assessed by X-ray Imaging
The angle between tibial and femur in the transverse plane
Measured: At baseline
Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography
Young's modulus by ultrasound elastography
Measured: At baseline and one week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Mar 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Responsible party
- Sponsor
- Investigators
- Siu Ngor Fu, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628508
- Sponsor's protocol ID
- HSEARS20170406003
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2018
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Tibia Torsion and Passive Muscle Stiffness of Quadriceps as Two Important Contributors of Joint Loading During Walking in People With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03628508
- Acronym / sponsor ID
- HSEARS20170406003
- Conditions
- Osteoarthritis, Knee
- Keywords
- muscle tension, alignment, knee osteoarthritis, loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 24 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older adults. It poses great challenge to the health care system due to its inability to be cured. Understanding factors associated with disease progression in KOA should assist the development of novel prevention/rehabilitation strategies. This study investigate factors including muscle properties, lower limb alignment and joint loading in patients with knee osteoarthritis before and after a six-week exercise program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseSix-week exercise including stretching, strengthening, endurance and gait modification |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 50-80
- having radiographic tibiofemoral joint OA in the medial compartment defined as Kellgren and Lawrence grade = 2 to 3
- having medial knee pain on most days of the month
- having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking
Key exclusion criteria (8 listed)
- having lateral tibiofemoral compartment osteophytes greater than the medial side.
- having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months
- having a systemic arthritic condition (e.g., rheumatoid arthritis)
- having a knee joint replacement or high tibial osteotomy in the past
- having any other muscular, joint or neurological condition influencing lower limb function
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 |
|---|---|---|
| ExerciseComprehensive exercise program including strengthening, stretching, gait modification etc. | Other | Exercise |
Primary outcome
Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System
Time frame: At baseline and one week after intervention
External knee moment in the frontal plane during early stance phase of walking
3 secondary outcomes
Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score
Time frame: At baseline and one week after intervention
Tibial Torsion as Assessed by X-ray Imaging
Time frame: At baseline
Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography
Time frame: At baseline and one week after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Siu Ngor Fu, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Osteoarthritis, Knee, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
Yes. Results are posted in the registry (first posted 24 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System (time frame: At baseline and one week after intervention). 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 16 Sep 2021.