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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Portugal
      • Porto, Portugal, 4200-072
        • E2S | P.PORTO - Escola Superior de Saúde do Politécnico do Porto

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Mobilization with movement
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:
  • MWM
  • Mulligan concept
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.
Procedure: Sham mobilization with movement
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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).
Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Escola Superior de Tecnologia da Saúde do Porto

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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