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

NCT06675318 | Completed

• 1 other identifier: Contralateral Exercise
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee; Exercise

Keywords

Knee osteoarthritis; Isokinetic exercise; Contralateral exercise effect; Quadriceps muscle thickness; Physical Function; Quality of life

Outcome Measures

Primary Outcomes (1)

• The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score

  WOMAC score evaluation following the last treatment session. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, validated questionnaire designed to assess pain, stiffness, and physical function in patients with knee and hip osteoarthritis. It consists of 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (17 items). Patients rate their symptoms on a Likert scale, with higher scores indicating worse pain, stiffness, or functional limitations. The WOMAC is commonly used in clinical research to evaluate the efficacy of various treatments for osteoarthritis.

  From enrollment day to the end of the rehabilitation program at 4 weeks.

Secondary Outcomes (6)

• Pain level; VAS score

  From enrollment day to the end of the rehabilitation program at 4 weeks

• Muscle strength

  From enrollment day to the end of the rehabilitation program at 4 weeks

• Physical function

  From enrollment day to the end of the rehabilitation program at 4 weeks

• Lower extremity function

  From enrollment day to the end of the rehabilitation program at 4 weeks

• Ultrasonographic Measurement of Thigh muscle thickness

  From enrollment day to the end of the rehabilitation program at 4 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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.

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

Study group

EXPERIMENTAL

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

Other: Cross training for quadriceps muscle of contralateral lower limb; Other: Quadriceps isometric exercises, along with hot pack and TENS for painful knee

Interventions

Cross training for quadriceps muscle of contralateral lower limb 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.

Study group

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

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

Control group; Study group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Gazi University Hospital, Department of Physical Medicine and Rehabilitation

Ankara, 06560, Turkey (Türkiye)

Location

Related Publications (6)

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

  PMID: 33406330 BACKGROUND

• 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.

  PMID: 18296075 BACKGROUND

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

  PMID: 12817660 BACKGROUND

• 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.

  PMID: 18433671 BACKGROUND

• 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.

  PMID: 32610511 BACKGROUND

• 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.

  PMID: 29287067 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Jale Meray, MD

  Gazi University Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical and demographic data collection and statistical analyses will be conducted by a blinded researcher with respect to the treatment group and clinical findings.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Physical Medicine and Rehabilitation, Principal Investigator, M.D.

Model Details: A prospective cohort study involving two parallel groups with randomization control

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: November 5, 2024
• Study Start: November 30, 2022
• Primary Completion: July 31, 2023
• Study Completion: August 31, 2023
• Last Updated: November 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)