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Clinical Trials/NCT05925517
NCT05925517
Completed
Not Applicable

The Effect of Graded Motor Imagery on Pain and Function in Individuals With Knee Osteoarthritis: A Randomized Controlled Trial

Artvin Coruh University1 site in 1 country46 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Artvin Coruh University
Enrollment
46
Locations
1
Primary Endpoint
Pain Intensity
Status
Completed
Last Updated
last year

Overview

Brief Summary

The aim of this study is to investigate whether Graded Motor Imagery (GMI) application is as effective as Transcutaneous Electrical Nerve Stimulation (TENS) in individuals with knee osteoarthritis (OA). The objectives are to improve range of motion (ROM) and muscle strength, reduce pain and stiffness, increase pain pressure threshold, and enhance function and physical performance through GMI application.

Detailed Description

46 voluntary patients with knee OA, aged between 45-64 years will be randomly divided into two groups: GMI group and TENS group. Interventions will be applied for 8 weeks, 3 times a week (24 sessions). Both groups will receive conventional physiotherapy and home exercises in addition to GMI or TENS treatment. The patients will be assessed before, after treatment and six-week follow-up. Knee pain will be evaluated using the Visual Analog Scale (VAS), pressure pain threshold will be measured using an algometer, pain, function, and stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), active knee range of motion will be measured using a digital goniometer, muscle strength will be evaluated using a hand-held dynamometer, and function will be assessed using the Timed Up and Go Test.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
March 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Artvin Coruh University
Responsible Party
Principal Investigator
Principal Investigator

Zeynep Yıldız Kızkın

Lecturer

Artvin Coruh University

Eligibility Criteria

Inclusion Criteria

  • Minimum score of 24 on the Mini Mental State Examination (indicating no mild or severe dementia)
  • Diagnosis of moderate unilateral knee osteoarthritis persisting for more than 12 months according to American College of Rheumatology (ACR) criteria
  • Experience of pain with a severity rating of 3 or higher on the Visual Analog Scale (VAS) for activities such as stair climbing, sitting, and squatting, lasting for at least 6 months (moderate to severe pain)
  • Age between 45 and 64 years
  • Residing in the city where the study is conducted
  • Ability to walk independently
  • Presence of limitations in knee range of motion (ROM)
  • Symptomatic and radiographically confirmed OA diagnosis of Kellgren and Lawrence grade I-III

Exclusion Criteria

  • Patients who are unwilling to participate in the study
  • Patients presenting with secondary OA due to conditions such as rheumatoid arthritis, gout, septic arthritis, tuberculosis, tumor, trauma, hemophilia, major medical or psychiatric disorders, recent fractures, presence of effusion or open reduction and internal fixation in the knee
  • Presence of a neuromuscular disease
  • History of intra-articular injections in the past 6 months
  • Patients undergoing medication changes
  • Presence of any chronic illness that would hinder participation in the treatment program
  • Participation in a physiotherapy program for OA in the last 12 weeks
  • Movement limitations or limb deficiency in the contralateral lower extremity
  • Presence of visual or hearing problems that would affect treatment adherence.

Outcomes

Primary Outcomes

Pain Intensity

Time Frame: 6-week follow-up

Visual Analogue Scale (VAS) will be used to evaluate the severity of pain felt around the knee joint. Participants will be asked to mark the severity of the pain they feel (rest, activity and night) on a 10 cm horizontal line, from 0 (no pain) to 10 (unbearable pain).

Pain Pressure Threshold

Time Frame: 6-week follow-up

The pain pressure threshold will be measured using a algometer. The pain pressure threshold will be evaluated at two points while the patient is lying in a lateral position: 1. point located 2 cm below the medial edge of the patella, and 2. point located 2 cm below the lateral edge of the patella. The evaluator will position the algometer perpendicular to each point and apply gradual pressure at a constant rate of approximately 0.5 kg/cm2/s. The pressure will be increased until the participant reports feeling pain. Each point considered for analysis will be assessed three times, and the average value will be recorded.

WOMAC Pain Subscale

Time Frame: 6-week follow-up

The subscale can take a score between 0-20 and evaluates pain during walking on flat ground, going up and down stairs, standing, sitting and lying down.

Secondary Outcomes

  • Isometric Muscle Strength(6-week follow-up)
  • Mini Mental State Examination(6-week follow-up)
  • Western Ontario and McMaster University Osteoarthritis Index (WOMAC)(6-week follow-up)
  • Range of Motion (ROM)(6-week follow-up)
  • Timed Get Up and Go Test (TUG)(6-week follow-up)

Study Sites (1)

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