Effect of Lumbar Stabilization on Knee OA

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04458753
Collaborator
(none)
80
1
2
17.7
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Lumbar focused exercises
  • Other: Knee focused exercises
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 weeksTwo 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
Masking:
Single (Participant)
Masking Description:
Patients will not know in which group they assigned
Primary Purpose:
Treatment
Official Title:
Effect of Lumbar Core Strengthening on Pain, Disability, Proprioception, and Quadriceps Strength in Knee Osteoarthritis
Actual Study Start Date :
Jun 10, 2020
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lumbar focused + knee focused exercise group

Will receive strengthening of back , abdominal, and quadriceps muscles, and stretching if calf and Hamstring muscles

Other: Lumbar focused exercises
Transersus abdominis activation Multifidus activation Back extension exercise Curl up abdominal exercise
Other Names:
  • Core training
  • Core stability
  • Other: Knee focused exercises
    Strengthening of quadriceps Stretching of calf and Hamstring muscles
    Other Names:
  • Traditional knee program
  • Active Comparator: Knee focused exercise group

    Will receive strengthening of quadriceps and stretching of calf and Hamstring muscles

    Other: Knee focused exercises
    Strengthening of quadriceps Stretching of calf and Hamstring muscles
    Other Names:
  • Traditional knee program
  • Outcome Measures

    Primary Outcome Measures

    1. Average Knee Pain during last week [1year]

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

    2. Quadriceps isometric strength [1 year]

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

    Secondary Outcome Measures

    1. Disability [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 [1year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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..).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr AlAiny hospital, Cairo university Giza Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Chair: Mohammed S Abdelsalam, Ass prof, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Adel Motawea Elsayed Zedan, Principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04458753
    Other Study ID Numbers:
    • 012/002731
    First Posted:
    Jul 7, 2020
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Adel Motawea Elsayed Zedan, Principal investigator, Cairo University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 9, 2022