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Completed

NCT Number: NCT04458753

Effect of Lumbar Stabilization on Knee OA

This study will be conducted to investigate the role of lumbar core strengthening in reducing knee pain and disability, and improving knee proprioception and Quadriceps strength in patients with knee OA.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr AlAiny hospital, Cairo university

Giza, Egypt

About this study

Osteoarthritis (OA) is a highly prevalent degenerative joint disease that impacts quality of life and puts a burden on health care costs. Idiopathic knee OA is an age-related disease, with prevalence ranging from 19-28%. Aetiology of OA (whether systemic or mechanical) remains unclear.

Lumbar spine has been reported to be associated with knee joint because of the biomechanical interrelationship. Decreased lumbar lordosis (that may indicate weak back extensors) and range of motion (that may indicate weak core stabilizers) had significant correlations with an increased spinal inclination angle, which was an independent factor related to knee OA (by increasing knee flexion angle). Knee OA may radiate pain to the back that together lead to more limited hip motion causing overloaded knees. Convergence presents between nerve roots supplying mid-lumbar muscles and joints, and that supply femoral nerve and quadriceps. Progression of knee OA is associated with progression of lumbar spine osteoarthritis. Altered trunk kinematics may cause altered tibiofemoral kinematics.

Strengthening of trunk extensors may be very important for knee OA as fatiguing back extensors led to 1) increased quadriceps inhibition (QI) that may lead to poor attenuation of ground reaction forces and excessive forces on the knees, 2) altered standing postural control, 3) a forward-leaned posture that increases the external knee moments, 4) a reduction in trunk proprioception.

Core stabilization exercises combined with knee-focused exercise or combined with hip strengthening resulted in less pain and better function. Interestingly, these studies included only patellofemoral pain and OA patients. This program may benefit knee OA patients as well. Strength, neuromuscular training and lumbopelvic stabilization reduced muscle weakness (of quadriceps and hip abductors), pain, and disability in men with mild knee OA. However, specific role of lumbar core muscles on knee OA, their effect on wider population (including females) and their effect on higher severity knee OA are lacking.

Strengthening of trunk core muscles may help pelvic stability which found to be beneficial in improving the trunk and lower extremity movement control, hip muscles strength, gait speed and daily activities. However, this done in stroke patients, it is hypothesized to benefit knee OA patients as well. Assessment and treatment of the trunk musculature should be considered in the rehabilitation of patients who demonstrate abnormal lower-extremity kinematics as found in knee OA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Knee pain for most days of previous month
  • Age 40- 65 years Knee OA grade 2-3 on kellgren- Lawrence grading scale. Unilateral or bilateral (provided that they radiologically have one knee ≤ grade 1 on KL score, and clinically pain ≤2 in VAS. The more severally affected knee will be included in evaluation and treatment) BMI= 25-32 kg/m2.

Exclusion criteria

  • Symptomatic hip OA Hip or pelvis trauma Knee or hip infection Congenital or developmental disorder of lower limbs Intra-articular corticosteroid or hyaluronic acid injection into the knee within the last 3 months.

Previous surgery of the affected knee or spine. Significant injury to the knee within the past 6 months. Any disease or medication worsens physical function or hampers with knee evaluation (e.g. rheumatoid arthritis, canal stenosis..).

Treatment and study plan

Lumbar focused exercises

Other

Transersus abdominis activation Multifidus activation Back extension exercise Curl up abdominal exercise

Other names: Core training, Core stability

Knee focused exercises

Other

Strengthening of quadriceps Stretching of calf and Hamstring muscles

Other names: Traditional knee program

Primary outcomes

  1. Average Knee Pain during last week

    Time frame: 1year

    Measured with visual analogue scale; 10 cm line, zero: no pain, 10: worst pain, during last week

  2. Quadriceps isometric strength

    Time frame: 1 year

    Measured with Hand held dynamometer from supine, knee flexed 30 degrees

Secondary outcomes

  1. Disability

    Time frame: 1 year

    Measured with Aggregate locomotor function score ( sum if 3 timing scires; up and diwn 7 stairs, 8 m walk, rising from chair)

  2. Knee Proprioception absolute angular error

    Time frame: 1year

    Active joint angular reproduction at 30 degree knee flexion from sitting using inclinometer

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Lumbar Core Strengthening on Pain, Disability, Proprioception, and Quadriceps Strength in Knee Osteoarthritis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 7, 2020
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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