Clinical trial NCT04458753: Effect of Lumbar Stabilization on Knee OA
Official title: Effect of Lumbar Core Strengthening on Pain, Disability, Proprioception, and Quadriceps Strength in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Lumbar core strengthening exercises
Dpinal stabilization training
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups; group A will be treated with exercises directed to lumbar and knee, group B will receive exercises directed to knee only. 3 sessions/ week for 4 weeks
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Knee pain for most days of previous month
2. 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..).

Primary outcomes:
measure: Average Knee Pain during last week
timeFrame: 1year
measure: Quadriceps isometric strength
timeFrame: 1 year
Secondary outcomes:
measure: Disability
timeFrame: 1 year
measure: Knee Proprioception absolute angular error
timeFrame: 1year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Kasr AlAiny hospital, Cairo university
Study officials:
affiliation: Cairo University
name: Mohammed S Abdelsalam, Ass prof
role: STUDY_CHAIR
References:
citation: Foroughi F, Sobhani S, Yoosefinejad AK, Motealleh A. Added Value of Isolated Core Postural Control Training on Knee Pain and Function in Women With Patellofemoral Pain Syndrome: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Feb;100(2):220-229. doi: 10.1016/j.apmr.2018.08.180. Epub 2018 Sep 26.