Knee Osteoarthritis (Knee OA)NCT06887868
Immediate Effect of Mobilization with Movement on Squat Self-reported Functional Ability, Pain Intensity, and Pain-free Range of Motion in People with Knee Osteoarthritis
A study testing Mobilization with movement in people with Knee Osteoarthritis (Knee OA), run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
Mobilization with movement (MWM) appears to reduce pain, improve knee range of motion, and enhance physical functioning in individuals with knee osteoarthritis (KOA). However, it remains unclear whether the severity grading of structural damage in KOA affects its effects. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- Mobilization with movement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2022to 31 Jul 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female;
- aged over 45 years;
- clinically diagnosed with symptomatic unilateral KOA, classified as grade 1-3 according to the Kellgren and Lawrence system;
- fulfilled the classification criteria of the American College of Rheumatology for KOA;
- reported frequent episodes of pain in the knee joint during sit-to-stand movements for at least 3 months.
Who cannot join
- had KOA secondary to rheumatoid arthritis and other inflammatory and autoimmune conditions;
- reported lumbar pain radiating to the knee or lumbar pain as the primary complaint;
- had a history of knee or lower limb surgery;
- had a systemic or local infection;
- had received an intra-articular corticosteroid or hyaluronic acid injection within the past 6 months;
- reported current or past (within 4 weeks) oral corticosteroid use;
- had any condition in the lower limbs that would prevent performing the deep squat test;
- had clinical conditions in which manual therapy is generally contraindicated (such as fracture, osteoporosis, instability, infectious arthritis, tumors, joint ankylosis, acute inflammatory disorders, or lack of a diagnosed joint lesion).
Trial locations and contacts
1 site in 1 country.
Portugal1 site
E2S | P.PORTO - Escola Superior de Saúde do Politécnico do Porto
Porto, Porto District, 4200-072
About this study
Official title: Immediate Effect of Mobilization with Movement on Squat Self-reported Functional Ability, Pain Intensity, and Pain-free Range of Motion in People with Knee Osteoarthritis: a Randomized Controlled Trial
Mobilization with movement (MWM) appears to reduce pain, improve knee range of motion, and enhance physical functioning in individuals with knee osteoarthritis (KOA). However, it remains unclear whether the severity grading of structural damage in KOA affects its effects. This study aims to analyze the immediate effect of MWM on squat self-reported functional ability, pain intensity, and pain-free range of motion in people with KOA, and to verify it its effect is influenced by the severity grading of structural damage.
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- Mobilization with movement, Sham mobilization with movement
- Keywords
- Knee Osteoarthritis, manual therapy, mobilization with movement, functional status, Mulligan concept, neurophysiological effect
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization with movementProcedure or surgery
Also called MWM, Mulligan concept
Manual application of a sustained translational or rotational glide force, either medial or lateral, on the tibia, while an active partial weight-bearing lunge movement was performed.
Sham mobilization with movementProcedure or surgery
The physiotherapist mimicked the pain-reducing glide direction without applying glide force while the participants performed the active lunge movement. To achieve this, the physiotherapist's hands lightly touched the knee skin, with one hand on the tibia and the other on the femur over the joint surfaces.
| Study group | Role | What they receive |
|---|---|---|
| MWM | Experimental | The intervention group received the MWM technique, which involved the manual application of a sustained translational or rotational glide force, either medial or lateral, on the tibia, while an active partial weight-bearing lunge movement was performed. All glide forces were tested in a randomly pre-established order, and the most effective force for symptom relief and improvement in knee range of motion was selected for the intervention. Receives: Procedure: Mobilization with movement |
| Sham MWM | Sham comparator | In the sham group, the participants underwent a similar procedure to those in the intervention group. The physiotherapist mimicked the pain-reducing glide direction without applying glide force while the participants performed the active lunge movement. To achieve this, the physiotherapist's hands lightly touched the knee skin, with one hand on the tibia and the other on the femur over the joint surfaces. The volume of the sham MWM technique was identical to that of the MWM technique administered to the intervention group. Receives: Procedure: Sham mobilization with movement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional ability
The Patient-Specific Functional Scale was used to assess self-reported functional ability. This scale is a self-reported, valid, and responsive outcome measure used to quantify activity limitations and evaluate functional outcomes for individuals with musculoskeletal conditions. Participants rated their current level of ability to performing the deep squat test on an 11-point scale at a level experienced prior to injury or change in functional status, where "0" represents "unable to perform" and "10" represents "able to perform at prior level.
Measured: Baseline
Knee Pain
The Numeric Pain Rating Scale is a self-reported, valid, and responsive outcome measure that was used in this study to quantify pain intensity. Participants rated their current pain intensity related to performing the deep squat test on a scale divided into eleven equal parts, numbered consecutively from 0 to 10, where "0" represents "No Pain" and "10" represents "Worst Possible Pain" (the most intense pain imaginable).
Measured: Baseline
Pain free Range of Motion (ROM)
This test has been advocated as a useful method for evaluating knee pain and function. Participants began the deep squat test by standing with their feet flat on the floor, approximately shoulder-width apart, aligned in the sagittal plane, and their hands placed on their pelvis (adapted from the original test description). They were then instructed to squat (buttocks towards the heels) as low as possible until the onset of pain, while maintaining an upright torso, avoiding asymmetric weight shift, and keeping their heels and toes in position. Before the test, participants viewed a demonstration video to optimize their understanding of the procedures. Additionally, they were given the opportunity to perform a practice trial of the deep squat test at a pain-free range of motion.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start1 May 2022
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Ferreira Carneiro, Escola Superior de Tecnologia da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887868
- Sponsor's protocol ID
- CE2023/17
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Mobilization with Movement on Squat Self-reported Functional Ability, Pain Intensity, and Pain-free Range of Motion in People with Knee Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06887868
- Acronym / sponsor ID
- CE2023/17
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Knee Osteoarthritis, manual therapy, mobilization with movement, functional status, Mulligan concept, neurophysiological effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 20 Mar 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.
Mobilization with movement (MWM) appears to reduce pain, improve knee range of motion, and enhance physical functioning in individuals with knee osteoarthritis (KOA). However, it remains unclear whether the severity grading of structural damage in KOA affects its effects. This study aims to analyze the immediate effect of MWM on squat self-reported functional ability, pain intensity, and pain-free range of motion in people with KOA, and to verify it its effect is influenced by the severity grading of structural damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWM | Experimental | Procedure: Mobilization with movementThe intervention group received the MWM technique, which involved the manual application of a sustained translational or rotational glide force, either medial or lateral, on the tibia, while an active partial weight-bearing lunge movement was performed. All glide forces were tested in a randomly pre-established order, and the most effective force for symptom relief and improvement in knee range of motion was selected for the intervention. |
| Sham MWM | Sham comparator | Procedure: Sham mobilization with movementIn the sham group, the participants underwent a similar procedure to those in the intervention group. The physiotherapist mimicked the pain-reducing glide direction without applying glide force while the participants performed the active lunge movement. To achieve this, the physiotherapist's hands lightly touched the knee skin, with one hand on the tibia and the other on the femur over the joint surfaces. The volume of the sham MWM technique was identical to that of the MWM technique administered to the intervention group. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- male or female;
- aged over 45 years;
- clinically diagnosed with symptomatic unilateral KOA, classified as grade 1-3 according to the Kellgren and Lawrence system;
- fulfilled the classification criteria of the American College of Rheumatology for KOA;
- reported frequent episodes of pain in the knee joint during sit-to-stand movements for at least 3 months.
Key exclusion criteria (8 listed)
- had KOA secondary to rheumatoid arthritis and other inflammatory and autoimmune conditions;
- reported lumbar pain radiating to the knee or lumbar pain as the primary complaint;
- had a history of knee or lower limb surgery;
- had a systemic or local infection;
- had received an intra-articular corticosteroid or hyaluronic acid injection within the past 6 months;
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 |
|---|---|---|
| Mobilization with movementAlso: MWM, Mulligan conceptManual application of a sustained translational or rotational glide force, either medial or lateral, on the tibia, while an active partial weight-bearing lunge movement was performed. | Procedure or surgery | MWM |
| Sham mobilization with movementThe physiotherapist mimicked the pain-reducing glide direction without applying glide force while the participants performed the active lunge movement. To achieve this, the physiotherapist's hands lightly touched the knee skin, with one hand on the tibia and the other on the femur over the joint surfaces. | Procedure or surgery | Sham MWM |
Primary outcome
Functional ability
Time frame: Baseline
The Patient-Specific Functional Scale was used to assess self-reported functional ability. This scale is a self-reported, valid, and responsive outcome measure used to quantify activity limitations and evaluate functional outcomes for individuals with musculoskeletal conditions. Participants rated their current level of ability to performing the deep squat test on an 11-point scale at a level experienced prior to injury or change in functional status, where "0" represents "unable to perform" and "10" represents "able to perform at prior level.
Knee Pain
Time frame: Baseline
The Numeric Pain Rating Scale is a self-reported, valid, and responsive outcome measure that was used in this study to quantify pain intensity. Participants rated their current pain intensity related to performing the deep squat test on a scale divided into eleven equal parts, numbered consecutively from 0 to 10, where "0" represents "No Pain" and "10" represents "Worst Possible Pain" (the most intense pain imaginable).
Pain free Range of Motion (ROM)
Time frame: Baseline
This test has been advocated as a useful method for evaluating knee pain and function. Participants began the deep squat test by standing with their feet flat on the floor, approximately shoulder-width apart, aligned in the sagittal plane, and their hands placed on their pelvis (adapted from the original test description). They were then instructed to squat (buttocks towards the heels) as low as possible until the onset of pain, while maintaining an upright torso, avoiding asymmetric weight shift, and keeping their heels and toes in position. Before the test, participants viewed a demonstration video to optimize their understanding of the procedures. Additionally, they were given the opportunity to perform a practice trial of the deep squat test at a pain-free range of motion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization with movement in people with Knee Osteoarthritis (Knee OA), run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 5 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 24 Mar 2025. 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 Portugal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional ability (time frame: Baseline). 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?
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 24 Mar 2025.