Knee OsteoarthritisNCT05767788

Mobilization With Movement (MWM) on Knee Osteoarthritis (OA)

A study testing Movement with Mobilization (MWM) in people with Knee Osteoarthritis, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Movement with mobilization (MWM) is an effective manual therapy to improve pain and function of patients with knee osteoarthritis (OA). However, immediate, and prolonged effects after prolonged MWM period was under-investigated. In this double-blinded randomized control trial, 40 patients are needed. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Knee Osteoarthritis
What is being tested?: Movement with Mobilization (MWM)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteHong Kong
Study dates: 10 Dec 2022to 10 May 2023
Phase: Interventional
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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

History of knee OA for at least 1-year
Pain intensity level ≥ 3 on a 10-cm Visual Analogue Scale (VAS)
Both unilateral or bilateral knee pain
Having morning stiffness less than 30 minutes
Having crepitus on active movement
Having bony tenderness
Having bony enlargement

Who cannot join

Having active inflammatory or infectious knee conditions
Having bone integrity conditions like osteoporosis
Having knee joint instability
Having skin integrity conditions like frail skin or lower limb peripheral vascular disease
History of hip or knee fracture
History of knee surgical history
Use of knee corticosteroid or opioid injection

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Hong Kong

Other trials in Hong Kong

About this study

Official title: Effectiveness of Mobilization With Movement (MWM) on Patients With Knee Osteoarthritis (OA): A Double-blinded Randomized Sham-controlled Trial

Movement with mobilization (MWM) is an effective manual therapy to improve pain and function of patients with knee osteoarthritis (OA).

However, immediate, and prolonged effects after prolonged MWM period was under-investigated.

In this double-blinded randomized control trial, 40 patients are needed. The subjects and assessors will be blinded. Subjects in intervention group will receive MWM twice a week and corresponding home exercise for 6 weeks.

Participants in control group will only receive sham treatment with light touch.

The effects on knee pain in visual analogue scale (VAS); flexion and extension range of motion (ROM) by goniometer; strength by hand-held dynamometer; function by Timed Up and Go Test (TUG) and 30-second Chair Stand Test; and health-related quality of life (HRQoL) by Knee Injury and Osteoarthritis Outcome Score (KOOS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) just after, 1-month and 3-month after treatment will be compared with baseline. Six-month after treatment, KOOS and WOMAC will be conducted.

Conditions: Knee Osteoarthritis
Being tested: Movement with Mobilization (MWM), Sham Movement with Mobilization (Sham MWM)
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Movement with Mobilization (MWM)Other
Painful active functional knee movement is identified. The most comfortable passive medial, lateral, medial rotatory, lateral rotatory, postero-anterior, and antero-posterior glide, is applied to the knee of the patient.
Three sets of 10 repetitions are applied. Corresponding home MWM exercise is taught. The treatment is conducted for 12 sessions over 6 weeks.
Sham Movement with Mobilization (Sham MWM)Other
Painful active functional knee movement is identified. The most comfortable passive medial, lateral, medial rotatory, lateral rotatory, postero-anterior, and antero-posterior light-touch glide, is applied to the knee of the patient.
Three sets of 10 repetitions are applied. Corresponding home MWM exercise is taught. The treatment is conducted for 12 sessions over 6 weeks.

Study groups in NCT05767788
Study group	Role	What they receive
Movement with Mobilization (MWM)	Experimental	Active movement with passive mobilization gliding force Receives: Other: Movement with Mobilization (MWM)
Sham Movement with Mobilization (Sham MWM)	Sham comparator	Active movement with passive light touch gliding force Receives: Other: Sham Movement with Mobilization (Sham MWM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of pain in the Visual Analogue Scale (VAS)
Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked "no pain" and "worst imaginable pain", at the time of assessment.
Measured: The change before the start of treatment and after 6-week treatment
Change of pain in the Visual Analogue Scale (VAS)
Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked "no pain" and "worst imaginable pain", at the time of assessment.
Measured: The change before the start of treatment and 1-month after last treatment session
Change of pain in the Visual Analogue Scale (VAS)
Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked "no pain" and "worst imaginable pain", at the time of assessment.
Measured: The change before the start of treatment and 3-month after last treatment session

Secondary outcomes (26)

Change of time used in the Timed Up and Go Test (TUG)
Subjects will be instructed to get up from the chair and then walk to a target 3 meters away, turn around, walk back to the chair, and sit down. The time used will be recorded. An average of two testing trials will be used.
Measured: The change before the start of treatment and after 6-week treatment
Change of time used in the Timed Up and Go Test (TUG)
Subjects will be instructed to get up from the chair and then walk to a target 3 meters away, turn around, walk back to the chair, and sit down. The time used will be recorded. An average of two testing trials will be used.
Measured: The change before the start of treatment and 1-month after last treatment session
Change of time used in the Timed Up and Go Test (TUG)
Subjects will be instructed to get up from the chair and then walk to a target 3 meters away, turn around, walk back to the chair, and sit down. The time used will be recorded. An average of two testing trials will be used.
Measured: The change before the start of treatment and 3-month after last treatment session
Change of number of repetitions in the 30-second Chair Stand Test (30CST)
Subjects will be instructed to stand up from the chair and then return to sit down on the chair repeatedly for 30 seconds or until the subject fails to continue at any time point during the trial. Only 1 testing trial will be used.
Measured: The change before the start of treatment and after 6-week treatment
Change of number of repetitions in the 30-second Chair Stand Test (30CST)
Subjects will be instructed to stand up from the chair and then return to sit down on the chair repeatedly for 30 seconds or until the subject fails to continue at any time point during the trial. Only 1 testing trial will be used.
Measured: The change before the start of treatment and 1-month after last treatment session
Change of number of repetitions in the 30-second Chair Stand Test (30CST)
Subjects will be instructed to stand up from the chair and then return to sit down on the chair repeatedly for 30 seconds or until the subject fails to continue at any time point during the trial. Only 1 testing trial will be used.
Measured: The change before the start of treatment and 3-month after last treatment session
Change of knee flexors muscle strength by the hand-held dynamometer
A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's hamstrings muscles. Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position. The isometric peak force for flexion will be recorded respectively.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and after 6-week treatment
Change of knee flexors muscle strength by the hand-held dynamometer
A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's hamstrings muscles. Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position. The isometric peak force for flexion will be recorded respectively.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and 1-month after last treatment session
Change of knee flexors muscle strength by the hand-held dynamometer
A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's hamstrings muscles. Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position. The isometric peak force for flexion will be recorded respectively.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and 3-month after last treatment session
Change of knee extensors muscle strength by the hand-held dynamometer
A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's quadriceps and muscles.
Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position.
The isometric peak force for flexion and extension will be recorded respectively.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and after 6-week treatment
Change of knee extensors muscle strength by the hand-held dynamometer
A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's quadriceps and muscles.
Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position.
The isometric peak force for flexion and extension will be recorded respectively.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and 1-month after last treatment session
Change of knee extensors muscle strength by the hand-held dynamometer
A digital dynamometer will be used to measure the muscle strength (in kilograms) of the subject's quadriceps and muscles.
Subjects will be guided to sit with their arms crossed at the shoulders and hold against their chest, back straight, knees relax in 90 degrees flexion in a high sitting position.
The isometric peak force for flexion and extension will be recorded respectively.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and 3-month after last treatment session
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best).
Measured: The change before the start of treatment and after 6-week treatment
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best).
Measured: The change before the start of treatment and 1-month after last treatment session
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best).
Measured: The change before the start of treatment and 3-month after last treatment session
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
A health-related quality of life questionnaire. The score ranges from 0% (the worst) to 100% (the best).
Measured: The change before the start of treatment and 6-month after last treatment session
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best).
Measured: The change before the start of treatment and after 6-week treatment
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best).
Measured: The change before the start of treatment and 1-month after last treatment session
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best).
Measured: The change before the start of treatment and 3-month after last treatment session
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
A health-related quality of life questionnaire. The score ranges from 0 (the worst) to 100 (the best).
Measured: The change before the start of treatment and 6-month after last treatment session
Change of active knee flexion range of motion by the standard goniometer
The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and after 6-week treatment
Change of active knee flexion range of motion by the standard goniometer
The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and 1-month after last treatment session
Change of active knee flexion range of motion by the standard goniometer
The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and 3-month after last treatment session
Change of active knee extension range of motion by the standard goniometer
The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and after 6-week treatment
Change of active knee extension range of motion by the standard goniometer
The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and 1-month after last treatment session
Change of active knee extension range of motion by the standard goniometer
The active range of motion for knee flexion will be measured with a standard goniometer on the painful knee in supine.
An average of 3 testing trials will be used.
Measured: The change before the start of treatment and 3-month after last treatment session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 202210 May 2023

First posted14 Mar 2023
Study start10 Dec 2022
Primary completion10 May 2023 (estimated)
Study completion10 May 2023 (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.
More trials run by The Hong Kong Polytechnic 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05767788
Sponsor's protocol ID: MWMKOA
Status last verified: Jan 2023
First submitted: 31 Jan 2023
Last updated: 14 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Mobilization With Movement (MWM) on Patients With Knee Osteoarthritis (OA): A Double-blinded Randomized Sham-controlled Trial
ClinicalTrials.gov ID: NCT05767788
Acronym / sponsor ID: MWMKOA
Conditions: Knee Osteoarthritis
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 10 Dec 2022 (actual)
Primary completion: 10 May 2023 (estimated)
Study completion: 10 May 2023 (estimated)
First posted: 14 Mar 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.

Movement with mobilization (MWM) is an effective manual therapy to improve pain and function of patients with knee osteoarthritis (OA).

However, immediate, and prolonged effects after prolonged MWM period was under-investigated.

Participants in control group will only receive sham treatment with light touch.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Movement with Mobilization (MWM)	Experimental	Other: Movement with Mobilization (MWM)Active movement with passive mobilization gliding force
Sham Movement with Mobilization (Sham MWM)	Sham comparator	Other: Sham Movement with Mobilization (Sham MWM)Active movement with passive light touch gliding force

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

History of knee OA for at least 1-year
Pain intensity level ≥ 3 on a 10-cm Visual Analogue Scale (VAS)
Both unilateral or bilateral knee pain
Having morning stiffness less than 30 minutes
Having crepitus on active movement

Key exclusion criteria (7 listed)

Having active inflammatory or infectious knee conditions
Having bone integrity conditions like osteoporosis
Having knee joint instability
Having skin integrity conditions like frail skin or lower limb peripheral vascular disease
History of hip or knee fracture

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
Movement with Mobilization (MWM)Painful active functional knee movement is identified. The most comfortable passive medial, lateral, medial rotatory, lateral rotatory, postero-anterior, and antero-posterior glide, is applied to the knee of the patient. Three sets of 10 repetitions are applied. Corresponding home MWM exercise is taught. The treatment is conducted for 12 sessions over 6 weeks.	Other	Movement with Mobilization (MWM)
Sham Movement with Mobilization (Sham MWM)Painful active functional knee movement is identified. The most comfortable passive medial, lateral, medial rotatory, lateral rotatory, postero-anterior, and antero-posterior light-touch glide, is applied to the knee of the patient. Three sets of 10 repetitions are applied. Corresponding home MWM exercise is taught. The treatment is conducted for 12 sessions over 6 weeks.	Other	Sham Movement with Mobilization (Sham MWM)

Primary outcome

Change of pain in the Visual Analogue Scale (VAS)
Time frame: The change before the start of treatment and after 6-week treatment
Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked "no pain" and "worst imaginable pain", at the time of assessment.
Change of pain in the Visual Analogue Scale (VAS)
Time frame: The change before the start of treatment and 1-month after last treatment session
Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked "no pain" and "worst imaginable pain", at the time of assessment.
Change of pain in the Visual Analogue Scale (VAS)
Time frame: The change before the start of treatment and 3-month after last treatment session
Subjects will indicate the pain level on a 100-millimeter line with endpoints, marked "no pain" and "worst imaginable pain", at the time of assessment.

26 secondary outcomes

Change of time used in the Timed Up and Go Test (TUG)
Time frame: The change before the start of treatment and after 6-week treatment
Change of time used in the Timed Up and Go Test (TUG)
Time frame: The change before the start of treatment and 1-month after last treatment session
Change of time used in the Timed Up and Go Test (TUG)
Time frame: The change before the start of treatment and 3-month after last treatment session
Change of number of repetitions in the 30-second Chair Stand Test (30CST)
Time frame: The change before the start of treatment and after 6-week treatment
Change of number of repetitions in the 30-second Chair Stand Test (30CST)
Time frame: The change before the start of treatment and 1-month after last treatment session
Change of number of repetitions in the 30-second Chair Stand Test (30CST)
Time frame: The change before the start of treatment and 3-month after last treatment session
Change of knee flexors muscle strength by the hand-held dynamometer
Time frame: The change before the start of treatment and after 6-week treatment
Change of knee flexors muscle strength by the hand-held dynamometer
Time frame: The change before the start of treatment and 1-month after last treatment session
Change of knee flexors muscle strength by the hand-held dynamometer
Time frame: The change before the start of treatment and 3-month after last treatment session
Change of knee extensors muscle strength by the hand-held dynamometer
Time frame: The change before the start of treatment and after 6-week treatment
Change of knee extensors muscle strength by the hand-held dynamometer
Time frame: The change before the start of treatment and 1-month after last treatment session
Change of knee extensors muscle strength by the hand-held dynamometer
Time frame: The change before the start of treatment and 3-month after last treatment session
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: The change before the start of treatment and after 6-week treatment
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: The change before the start of treatment and 1-month after last treatment session
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: The change before the start of treatment and 3-month after last treatment session
Change of score of the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: The change before the start of treatment and 6-month after last treatment session
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: The change before the start of treatment and after 6-week treatment
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: The change before the start of treatment and 1-month after last treatment session
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: The change before the start of treatment and 3-month after last treatment session
Change of score of the Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: The change before the start of treatment and 6-month after last treatment session
Change of active knee flexion range of motion by the standard goniometer
Time frame: The change before the start of treatment and after 6-week treatment
Change of active knee flexion range of motion by the standard goniometer
Time frame: The change before the start of treatment and 1-month after last treatment session
Change of active knee flexion range of motion by the standard goniometer
Time frame: The change before the start of treatment and 3-month after last treatment session
Change of active knee extension range of motion by the standard goniometer
Time frame: The change before the start of treatment and after 6-week treatment
Change of active knee extension range of motion by the standard goniometer
Time frame: The change before the start of treatment and 1-month after last treatment session
Change of active knee extension range of motion by the standard goniometer
Time frame: The change before the start of treatment and 3-month after last treatment session

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
Individual participant dataSharing planned: Undecided

Related trials for Knee Osteoarthritis

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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.

KING HIM CHAN, BSc principal investigator

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

MING HON LEE, BSc principal investigator

Department of Rehabilitation Sciences, The Hong Kong Polytechnic University

YIK SING SHUM, BSc principal investigator

Department of Rehabilitation Sciences, 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 Movement with Mobilization (MWM) in people with Knee Osteoarthritis, 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 7 inclusion and 7 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 14 Mar 2023. 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. Some participants in this study may receive a placebo. 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?

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 pain in the Visual Analogue Scale (VAS) (time frame: The change before the start of treatment and after 6-week treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05767788.

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 14 Mar 2023.