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Effect of Lumbar Stabilization on Knee OA

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lumbar focused exercises
Knee focused exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Lumbar core strengthening exercises, Dpinal stabilization training

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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..).

Sites / Locations

  • Kasr AlAiny hospital, Cairo university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lumbar focused + knee focused exercise group

Knee focused exercise group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Average Knee Pain during last week
Measured with visual analogue scale; 10 cm line, zero: no pain, 10: worst pain, during last week
Quadriceps isometric strength
Measured with Hand held dynamometer from supine, knee flexed 30 degrees

Secondary Outcome Measures

Disability
Measured with Aggregate locomotor function score ( sum if 3 timing scires; up and diwn 7 stairs, 8 m walk, rising from chair)
Knee Proprioception absolute angular error
Active joint angular reproduction at 30 degree knee flexion from sitting using inclinometer

Full Information

First Posted
July 1, 2020
Last Updated
March 7, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04458753
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, Lumbar core strengthening exercises, Dpinal stabilization training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
Participant
Masking Description
Patients will not know in which group they assigned
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumbar focused + knee focused exercise group
Arm Type
Experimental
Arm Description
Will receive strengthening of back , abdominal, and quadriceps muscles, and stretching if calf and Hamstring muscles
Arm Title
Knee focused exercise group
Arm Type
Active Comparator
Arm Description
Will receive strengthening of quadriceps and stretching of calf and Hamstring muscles
Intervention Type
Other
Intervention Name(s)
Lumbar focused exercises
Other Intervention Name(s)
Core training, Core stability
Intervention Description
Transersus abdominis activation Multifidus activation Back extension exercise Curl up abdominal exercise
Intervention Type
Other
Intervention Name(s)
Knee focused exercises
Other Intervention Name(s)
Traditional knee program
Intervention Description
Strengthening of quadriceps Stretching of calf and Hamstring muscles
Primary Outcome Measure Information:
Title
Average Knee Pain during last week
Description
Measured with visual analogue scale; 10 cm line, zero: no pain, 10: worst pain, during last week
Time Frame
1year
Title
Quadriceps isometric strength
Description
Measured with Hand held dynamometer from supine, knee flexed 30 degrees
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Disability
Description
Measured with Aggregate locomotor function score ( sum if 3 timing scires; up and diwn 7 stairs, 8 m walk, rising from chair)
Time Frame
1 year
Title
Knee Proprioception absolute angular error
Description
Active joint angular reproduction at 30 degree knee flexion from sitting using inclinometer
Time Frame
1year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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..).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammed S Abdelsalam, Ass prof
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Kasr AlAiny hospital, Cairo university
City
Giza
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30267667
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.
Results Reference
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Effect of Lumbar Stabilization on Knee OA

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