Clinical trial NCT06675318: The Effect of Contralateral Isokinetic Lower Extremity Exercises in Unilateral Painful Knee Osteoarthritis
Official title: The Effect of Contralateral Isokinetic Lower Extremity Exercises Added to Conventional Rehabilitation in Unilateral Painful Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Exercise
Keywords: Knee osteoarthritis
Isokinetic exercise
Contralateral exercise effect
Quadriceps muscle thickness
Physical Function
Quality of life
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective cohort study involving two parallel groups with randomization control
Primary purpose: TREATMENT

Brief summary: Patients with unilateral knee pain due to knee osteoarthritis presenting to our clinic will be included in a 20-session treatment program, either on an outpatient basis or as inpatients at our clinic. The patients will be divided into 2 groups, and conventional treatments including isometric exercises, TENS (Transcutaneous Electrical Nerve Stimulation) and hot pack therapy for the painful knee will be administered to both groups. In addition to these treatments, the intervention group will receive isokinetic exercise sessions using the Cybex 770 Norm isokinetic dynamometer system (Lumex Inc., Ronkonkoma, New York) at speeds of 60°/s and 180°/s according to the device's standard protocol, targeting the contralateral lower extremity. Subsequently, examinations and measurements will be conducted to evaluate patients for reduction in pain, increase in muscle strength, improvement in functionality, and increase in thigh muscle thickness.

Detailed description: Osteoartritis is the most common form of arthritis, originating from the failed repair of joint damage caused by stress initiated by any joint or periarticular tissue abnormality. Its most common symptom is pain. The long-term consequences of osteoarthritis include decreased physical activity, loss of conditioning, sleep disturbances, fatigue, depression, and disability. Factors associated with increased risk of knee osteoarthritis include advanced age, female gender, overweight or obesity, knee injury, occupational factors, and varus or valgus alignment of the knee.

With the increasing aging population, degenerative joint problems have become relevant to a large portion of society. Exercise is a fundamental component in the treatment of this chronic disease, which limits functionality and reduces quality of life.

A systematic review including 32 randomized controlled trials evaluating 5362 participants showed that various types of exercise provide improvement in pain, functionality, and quality of life in knee osteoarthritis.

Musculoskeletal pains can lead to cortical reorganization in both somatosensory and motor areas, which can reduce motor activity in both the affected and unaffected contralateral extremities. For example, a decrease in motor activity in both painful and pain-free contralateral extremities has been identified during acute pain and/or in the presence of chronic pain.

If exercise is performed to increase muscle strength on one side of the body, strength may also increase on the opposite side. This effect, called the contralateral exercise phenomenon, is typically measured in homologous muscles. Although known for over a century, most studies have not been well-designed to demonstrate the exact magnitude of the strength increase effect. However, an updated meta-analysis of 16 studies indicates that the size of the contralateral exercise effect is approximately 8% of baseline strength or about half of the increase in strength on the exercised side.

However, there are few studies examining the combined effects of contralateral lower extremity isokinetic exercises on pain, muscle thickness, and functionality. Therefore, the aim of this study is to demonstrate the effect of isokinetic exercises applied to the contralateral lower extremity added to routine treatment on muscle strength, muscle thickness, and functionality in the painful knee, and to show its potential relationship. We aim to provide clinicians with a new perspective on the treatment of knee osteoarthritis.

Eligibility criteria: Inclusion Criteria:

* To agree to participate in the study
* To be aged 50 years or older
* To have a clinically and radiographically confirmed diagnosis of knee osteoarthritis
* To have unilateral knee pain due to osteoarthritis (VAS \<2 in the contralateral knee, VAS \>2 in the painful knee)
* To have Kellgren-Lawrence Grade 1-3 in the painful knee and Kellgren-Lawrence Grade \<4 in the contralateral knee
* To have dominance of the right lower extremity

Exclusion Criteria:

* A history of previous lower extremity fractures or orthopedic surgery that would interfere with isokinetic and isometric exercises in both lower extremities
* The presence of significant sensorimotor deficits due to neurological diseases
* The presence of known inflammatory rheumatic diseases
* The presence of non-curable malignant tumors with bone metastasis
* The presence of neuropsychiatric diseases or conditions that would hinder cooperation
* Having undergone interventions such as injections for pain relief within the last 3 months

Primary outcomes:
measure: The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks.
Secondary outcomes:
measure: Pain level; VAS score
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: Muscle strength
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: Physical function
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: Lower extremity function
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: Ultrasonographic Measurement of Thigh muscle thickness
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
measure: Range of motion
timeFrame: From enrollment day to the end of the rehabilitation program at 4 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Gazi University Faculty of Medicine
name: Jale Meray, MD
role: STUDY_DIRECTOR
References:
citation: Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.
citation: Hawker GA, Stewart L, French MR, Cibere J, Jordan JM, March L, Suarez-Almazor M, Gooberman-Hill R. Understanding the pain experience in hip and knee osteoarthritis--an OARSI/OMERACT initiative. Osteoarthritis Cartilage. 2008 Apr;16(4):415-22. doi: 10.1016/j.joca.2007.12.017. Epub 2008 Mar 4.
citation: Flor H. Cortical reorganisation and chronic pain: implications for rehabilitation. J Rehabil Med. 2003 May;(41 Suppl):66-72. doi: 10.1080/16501960310010179.
citation: Arguis MJ, Perez J, Martinez G, Ubre M, Gomar C. Contralateral neuropathic pain following a surgical model of unilateral nerve injury in rats. Reg Anesth Pain Med. 2008 May-Jun;33(3):211-6. doi: 10.1016/j.rapm.2007.12.003.
citation: Cheon S, Lee JH, Jun HP, An YW, Chang E. Acute Effects of Open Kinetic Chain Exercise Versus Those of Closed Kinetic Chain Exercise on Quadriceps Muscle Thickness in Healthy Adults. Int J Environ Res Public Health. 2020 Jun 29;17(13):4669. doi: 10.3390/ijerph17134669.
citation: van Melick N, Meddeler BM, Hoogeboom TJ, Nijhuis-van der Sanden MWG, van Cingel REH. How to determine leg dominance: The agreement between self-reported and observed performance in healthy adults. PLoS One. 2017 Dec 29;12(12):e0189876. doi: 10.1371/journal.pone.0189876. eCollection 2017.