Investigation of the Effect of Movement Mobilization Concept on Sensory, Pain, Muscle Activation in Patients With Knee Osteoarthritis
1 other identifier
interventional
36
1 country
1
Brief Summary
Individuals with knee osteoarthritis are one of the groups most affected by musculoskeletal disorders and experience pain and mobility limitations that significantly limit their daily living activities. Quantitative sensory assessment in individuals with osteoarthritis plays a critical role in evaluating disease progression and treatment effectiveness by objectively measuring changes in sensory perception such as proprioception and nociception. These changes in sensory perception can negatively affect individuals' movement control and balance. In this context, evaluation of quantitative sensory parameters allows the development of more targeted and effective interventions in the rehabilitation processes of individuals with osteoarthritis. Additionally, electromyographic evaluation in individuals with osteoarthritis analyzes muscle activation levels, providing a better understanding of the impairments in muscle functions of these individuals. EMG data helps to design rehabilitation programs individually by determining to what degree muscles are activated and which muscle groups are more affected. Decreased muscle activation or abnormal muscle activation in individuals with osteoarthritis can negatively affect joint stability and mobility. Therefore, EMG evaluations are an objective method to evaluate the effectiveness of treatment strategies aimed at restoration of muscle functions in individuals with osteoarthritis. The quantitative sensory and EMG evaluations performed in this project aim to improve the quality of life of individuals by offering innovative approaches in the clinical management of individuals with osteoarthritis. Therefore, these evaluations are of critical importance for the original value and scientific contribution of our project. For these reasons, the selection of individuals with osteoarthritis and the detailed evaluations made on these individuals and its connection with the methods can be considered as the innovative and original aspect of our project. The aim of this study is to investigate the effect of the Mulligan movement mobilization concept on quantitative sensory parameters, pain and muscle activation levels in patients with knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
1 active site
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
July 25, 2024
CompletedStudy Start
First participant enrolled
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2025
CompletedJanuary 21, 2026
January 1, 2026
11 months
July 25, 2024
January 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Evaluation of muscle activation:
Evaluation of muscle activation with EMG: It will be evaluated with the Noraxon MyoMuscle system. (Noraxon Inc., Scottsdale, AZ, USA) sEMG (Noraxon myosystem DTS, USA) will be used to measure the electrical activity of the muscles. sEMG data of the muscles will be recorded and muscle activities will be analyzed. Ag/AgC superficial electrodes will be used for sEMG measurements. Superficial 8-channel EMG (Bilateral Quadrieps Femoris (rectus femoris, vastus lateralis, vastus medialis), Biceps femoris (long and short head), Semitendinosus).
2 mounth
Pain Sensation and Sensory Evaluation
Pressure pain thresholds (BAEs) are measured using a calibrated digital algometer (Algomed/MEDOC) by slowly increasing mechanical pressure at a computer-controlled rate of 1 kg/s. To elicit temporal summation in all of the above-mentioned regions, mechanical stimulation was applied 10 times using a digital algometer calibrated at 110% of the pressure pain threshold intensity with a 1-second interstimulus interval. When creating temporal summation, the procedure was started at least 2 minutes after the last PPT was measured to ensure that the tests were not contaminated. Before the first stimulus, study participants were asked to verbally indicate their pain levels at the first, fifth and tenth stimuli according to a visual analogue scale (VAS) placed in front of them. VAS is fixed with single digit numbers from 0 to 10, 0 being "no pain", 1-2 "very mild pain", 3-4 "mild pain", 5-6 "moderate pain", 7-8 " "severe pain" and 9-10 as "very severe unbearable pain".
2 mounth
Secondary Outcomes (5)
Muscle strength assessment
2 mounth
sit and reach test battery
2 mounth
Timed get up and go test
2 mounth
WOMAC
2 mounth
Tampa kinesiophobia scale
2 mounth
Study Arms (3)
Movement Mobilization Concept Group
EXPERIMENTALMWM and appropriate taping will be applied to the cases included in the Mulligan group, according to the Mulligan Concept, and home exercises will be given to the patient as recommended by the concept.
Sham Movement Mobilization Concept Group
SHAM COMPARATORThe technique will be applied to cases in the sham group with only hand contact, without any slippage or rotation in any direction. Then, rigid taping will be applied without any tension or direction, and home exercises will be given.
Control Group
ACTIVE COMPARATORSubjects in the control group will be shown home exercises customized for knee osteoarthritis and asked to continue them.
Interventions
Mulligan Concept MWM Mulligan Taping Mulligan Self Home Workout
The technique will be applied to cases in the sham group with only hand contact, without any slippage or rotation in any direction. Then, rigid taping will be applied without any tension or direction, and home exercises will be given.
Subjects in the control group will be shown home exercises customized for knee osteoarthritis and asked to continue them. Specialized Home Exercises for the Knee Joint 1. Lumbar extensor stretching, Hamstring stretching, hip flexors stretching, TFL stretching, 2. Straight leg raise (lying on back and side) 3. Bridge exercise 4. Drawing circles while lying on your back and side 5. Knee flexion-extension 6. Weight bearing exercises 7. Tiptoe exercise 8. Step climbing and descending exercise 9. Terminal knee extension 10. Strengthening the muscles around the hips
Eligibility Criteria
You may qualify if:
- Diagnosing knee OA according to the American College of Rheumatology (ACR) criteria (Primary knee OA diagnosis)
- Stage 2 or 3 patients according to Kellgren-Lawrence radiological staging criteria
- Patients with a disease duration of 6 months or longer
- Participants aged between 50 and 70
- Being able to walk without using assistive devices
- Body mass index is below 35 kg/m²
- Pain intensity must be between 3 and 7 according to the Numerical Pain Rating Scale
- Not having received physiotherapy in the last year.
You may not qualify if:
- Infiltration with steroids or local anesthetics in the year before the patient entered the study or during follow-up
- Obtaining the indication for surgery
- Severe hearing, vision and speech impairment
- Having serious systemic and cardiovascular diseases that prevent exercise
- Having a neurological disease
- Having a lower extremity deformity (severe varus or valgus deformity, significant joint instability and other orthopedic problems requiring surgical intervention)
- Patients with acute knee inflammation
- Having any disorder, syndrome or disease that may cause myofascial or neuropathic pain in the lower extremities, such as lumbar radiculopathy, meralgia paresthetica or Saphenous nerve compression.
- Cognitive deficit (Alzheimer's, dementia) revealed in the clinical history.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istinye University
Istanbul, Istanbul, 34010, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The research was designed as a double-blind randomized controlled study in which the participant and the evaluator were blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research assistant
Study Record Dates
First Submitted
July 25, 2024
First Posted
July 30, 2024
Study Start
July 25, 2024
Primary Completion
July 1, 2025
Study Completion
October 10, 2025
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share