NCT06887868

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
Last Updated

March 24, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

March 11, 2025

Last Update Submit

March 20, 2025

Conditions

Keywords

Knee Osteoarthritismanual therapymobilization with movementfunctional statusMulligan conceptneurophysiological effect

Outcome Measures

Primary Outcomes (3)

  • 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.

    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).

    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.

    Baseline

Study Arms (2)

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.

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.

Procedure: Sham mobilization with movement

Interventions

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.

Also known as: MWM, Mulligan concept
MWM

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.

Sham MWM

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

E2S | P.PORTO - Escola Superior de Saúde do Politécnico do Porto

Porto, Porto District, 4200-072, Portugal

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Movement

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 20, 2025

Study Start

May 1, 2022

Primary Completion

June 30, 2023

Study Completion

July 31, 2023

Last Updated

March 24, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations