NCT06280365

Brief Summary

The aim of this study is to investigate the effect of the MWM technique on pain, normal joint movement, proprioception and quality of life in patients with knee osteoarthritis (OA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 5, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 6, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

3 months

First QC Date

February 5, 2024

Last Update Submit

July 30, 2024

Conditions

Keywords

Knee OsteoarthritisMobilizationProprioceptionPain

Outcome Measures

Primary Outcomes (5)

  • Visual Analog Scale (VAS)

    VAS, which digitizes parameter values that cannot be measured numerically, was used to evaluate the pain intensity of the participants. The two extreme values of the parameter to be measured are written on the scale as 0 and 10. The person is asked to mark the value that best suits him/her on the scale. For pain, no pain and very severe pain; It is specified as 0 and 10. The person chooses a value according to his/her pain

    4 week change in pain intensity

  • Short form-36 (SF-36)

    SF-36, developed in 1992, consists of 36 items providing measurement to the following 8 dimensions: physical functioning (10 items), social functioning (2 items), role limitations due to physical problems (4 items), role limitations due to emotional problems (3 items), mental health (5 items), energy/vitality (4 items), pain (2 items), and general health perception (5 items). An increase in the score indicates a higher rate of improvement in health status.

    4-week change in quality of life

  • Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC)

    This survey is conducted to evaluate how much the routine activities in the participants' lives are affected by the knee problem. The survey included the following parameters: pain, physical function, and stiffness. A Likert system ranging from 1 to 5 is used. As the value increases, the intensity of the parameters increases

    4-week

  • Evaluation of proprioception

    To assess the participants' sense of proprioception, the method of actively reproducing the passive position without supporting the limb was used. In this assessment, where the angle is measured with a goniometer, the person closes their eyes. The limb is passively moved to the target angle and the person is asked to concentrate on the position. After 10 seconds, the starting point of the movement is returned. The person tries to find the target angle by actively moving the same limb. If the angle achieved at the end of the movement is different from the target angle, the difference is recorded as the deviation angle (used to 15° and 45° knee flexion).

    4-week change in proprioception

  • The range of motion

    A goniometer (Baseline plastic goniometer), which provides numerical and objective results, was used to measure the range of motion of the participants. Knee flexion for normal range of motion in the knee region and knee extension angles were evaluated.

    4-week

Study Arms (2)

MWM group

EXPERIMENTAL

Participants in group 2 will receive MWM technique treatment 3 times a week for 4 weeks. The patient should lie face down with a pillow over the knee and the physiotherapist should stand on the contralateral side for the application. The physiotherapist passes the belt around the waist to the patient's tibia edge. The knee is stabilized with one hand while the leg is supported with the other hand. The knee is moved medially without applying too much force through the belt and the patient is asked to stretch. If there is no pain, the movement is indicated. If pain occurs during the movement, the same procedure is performed for the lateral side by changing the position. It is important that the arch remains horizontal and does not cause rotation of the hip. The movement will be repeated 3 times at the point where there is no pain.

Other: Mulligan Mobilization with Movement Technique

Control Group

NO INTERVENTION

Participants in group 1 will receive conservative treatment 3 times a week for 4 weeks. Conservative treatment includes hot packs and traditional transcutaneous electrical nerve stimulation (TENS), an electrotherapy. All participants in the study will receive 20 minutes of hot pack application to the knee area each session by a physiotherapist. All participants in the study will receive TENS for 20 minutes each session from the physiotherapist, who will place personalized electrodes around the knee joint and adjust the current to the level the person can tolerate.

Interventions

Mobilization Technique

MWM group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being diagnosed with knee osteoarthritis,
  • being diagnosed with knee OA at the earliest 6 months ago

You may not qualify if:

  • Participants who were pregnant,
  • had knee surgery, had an infection,
  • had a pacemaker, had an infraction,
  • had cancer, or were receiving corticosteroid treatment were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emine Atıcı

Tuzla, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2024

First Posted

February 28, 2024

Study Start

May 6, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations