- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
March 20, 2025 updated by: Daniela Ferreira Carneiro, Escola Superior de Tecnologia da Saúde do Porto
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Porto, Portugal, 4200-072
- E2S | P.PORTO - Escola Superior de Saúde do Politécnico do Porto
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: MWM
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.
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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.
Other Names:
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Sham Comparator: Sham MWM
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional ability
Time Frame: Baseline
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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.
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Baseline
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Knee Pain
Time Frame: Baseline
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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).
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Baseline
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Pain free Range of Motion (ROM)
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
July 31, 2023
Study Registration Dates
First Submitted
March 11, 2025
First Submitted That Met QC Criteria
March 15, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 20, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE2023/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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