The Effect of Contralateral Isokinetic Lower Extremity Exercises in Unilateral Painful Knee Osteoarthritis

NCT ID: NCT06675318

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-30

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective cohort study involving two parallel groups with randomization control
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Clinical and demographic data collection and statistical analyses will be conducted by a blinded researcher with respect to the treatment group and clinical findings.

Study Groups

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Control group

Patients with unilateral painful knee osteoarthritis who are applied to Gazi University Faculty of Medicine PM\&R will be included. 20 sessions of conventional physical therapy and rehabilitation (isometric exercises, TENS, hot pack) for the symptomatic extremity will be applied to patients In the active control group.

Group Type ACTIVE_COMPARATOR

Quadriceps isometric exercises, along with hot pack and TENS for painful knee

Intervention Type OTHER

10 repetitions of quadriceps isometric exercises in 3 sets, along with hot pack and TENS treatments for painful knee

Study group

Patients with unilateral painful knee osteoarthritis who are applied to Gazi University Faculty of Medicine PM\&R will be included. 20 sessions of conventional physical therapy and rehabilitation for the symptomatic extremity combined with isokinetic strengthening exercises for the asymptomatic extremity will be applied to patients In the experimental group

Group Type EXPERIMENTAL

Cross training for quadriceps muscle of contralateral lower limb

Intervention Type OTHER

An isokinetic exercise program consisting of 20 sessions conducted five days a week. The program begins with five repetitions at a speed of 60°/s, followed by sets of 5-15 repetitions with incremental increases of 30°/s. Rest periods of 30 seconds were included between sets.

Quadriceps isometric exercises, along with hot pack and TENS for painful knee

Intervention Type OTHER

10 repetitions of quadriceps isometric exercises in 3 sets, along with hot pack and TENS treatments for painful knee

Interventions

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Cross training for quadriceps muscle of contralateral lower limb

An isokinetic exercise program consisting of 20 sessions conducted five days a week. The program begins with five repetitions at a speed of 60°/s, followed by sets of 5-15 repetitions with incremental increases of 30°/s. Rest periods of 30 seconds were included between sets.

Intervention Type OTHER

Quadriceps isometric exercises, along with hot pack and TENS for painful knee

10 repetitions of quadriceps isometric exercises in 3 sets, along with hot pack and TENS treatments for painful knee

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Emine METIN IPEK

Research Assistant, Physical Medicine and Rehabilitation, Principal Investigator, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jale Meray, MD

Role: STUDY_DIRECTOR

Gazi University Faculty of Medicine

Locations

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Gazi University Hospital, Department of Physical Medicine and Rehabilitation

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021 Jan 7;384(1):51-59. doi: 10.1056/NEJMcp1903768. No abstract available.

Reference Type BACKGROUND
PMID: 33406330 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18296075 (View on PubMed)

Flor H. Cortical reorganisation and chronic pain: implications for rehabilitation. J Rehabil Med. 2003 May;(41 Suppl):66-72. doi: 10.1080/16501960310010179.

Reference Type BACKGROUND
PMID: 12817660 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18433671 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32610511 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29287067 (View on PubMed)

Other Identifiers

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Contralateral Exercise

Identifier Type: -

Identifier Source: org_study_id

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