NCT06527313

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

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 25, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

July 25, 2024

Last Update Submit

January 16, 2026

Conditions

Keywords

osteoartritismovement mobilization conceptmulligankneetaping

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

EXPERIMENTAL

MWM 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.

Behavioral: Movement Mobilization Concept, Exercise and Tape

Sham Movement Mobilization Concept Group

SHAM COMPARATOR

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.

Behavioral: Sham Movement Mobilization Concept, Exercise and Tape

Control Group

ACTIVE COMPARATOR

Subjects in the control group will be shown home exercises customized for knee osteoarthritis and asked to continue them.

Behavioral: Special Exercises

Interventions

Mulligan Concept MWM Mulligan Taping Mulligan Self Home Workout

Movement Mobilization Concept Group

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.

Sham Movement Mobilization Concept Group

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

Control Group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Movement DisordersOsteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Model Details: . The study will be planned as a parallel research with 3 groups.
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

Locations