<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04458753</url>
  </required_header>
  <id_info>
    <org_study_id>012/002731</org_study_id>
    <nct_id>NCT04458753</nct_id>
  </id_info>
  <brief_title>Effect of Lumbar Stabilization on Knee OA</brief_title>
  <official_title>Effect of Lumbar Core Strengthening on Pain, Disability, Proprioception, and Quadriceps Strength in Knee Osteoarthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to investigate the role of lumbar core strengthening in reducing&#xD;
      knee pain and disability, and improving knee proprioception and Quadriceps strength in&#xD;
      patients with knee OA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoarthritis (OA) is a highly prevalent degenerative joint disease that impacts quality of&#xD;
      life and puts a burden on health care costs. Idiopathic knee OA is an age-related disease,&#xD;
      with prevalence ranging from 19-28%. Aetiology of OA (whether systemic or mechanical) remains&#xD;
      unclear.&#xD;
&#xD;
      Lumbar spine has been reported to be associated with knee joint because of the biomechanical&#xD;
      interrelationship. Decreased lumbar lordosis (that may indicate weak back extensors) and&#xD;
      range of motion (that may indicate weak core stabilizers) had significant correlations with&#xD;
      an increased spinal inclination angle, which was an independent factor related to knee OA (by&#xD;
      increasing knee flexion angle). Knee OA may radiate pain to the back that together lead to&#xD;
      more limited hip motion causing overloaded knees. Convergence presents between nerve roots&#xD;
      supplying mid-lumbar muscles and joints, and that supply femoral nerve and quadriceps.&#xD;
      Progression of knee OA is associated with progression of lumbar spine osteoarthritis. Altered&#xD;
      trunk kinematics may cause altered tibiofemoral kinematics.&#xD;
&#xD;
      Strengthening of trunk extensors may be very important for knee OA as fatiguing back&#xD;
      extensors led to 1) increased quadriceps inhibition (QI) that may lead to poor attenuation of&#xD;
      ground reaction forces and excessive forces on the knees, 2) altered standing postural&#xD;
      control, 3) a forward-leaned posture that increases the external knee moments, 4) a reduction&#xD;
      in trunk proprioception.&#xD;
&#xD;
      Core stabilization exercises combined with knee-focused exercise or combined with hip&#xD;
      strengthening resulted in less pain and better function. Interestingly, these studies&#xD;
      included only patellofemoral pain and OA patients. This program may benefit knee OA patients&#xD;
      as well. Strength, neuromuscular training and lumbopelvic stabilization reduced muscle&#xD;
      weakness (of quadriceps and hip abductors), pain, and disability in men with mild knee OA.&#xD;
      However, specific role of lumbar core muscles on knee OA, their effect on wider population&#xD;
      (including females) and their effect on higher severity knee OA are lacking.&#xD;
&#xD;
      Strengthening of trunk core muscles may help pelvic stability which found to be beneficial in&#xD;
      improving the trunk and lower extremity movement control, hip muscles strength, gait speed&#xD;
      and daily activities. However, this done in stroke patients, it is hypothesized to benefit&#xD;
      knee OA patients as well. Assessment and treatment of the trunk musculature should be&#xD;
      considered in the rehabilitation of patients who demonstrate abnormal lower-extremity&#xD;
      kinematics as found in knee OA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">October 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Patients will not know in which group they assigned</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Average Knee Pain during last week</measure>
    <time_frame>1year</time_frame>
    <description>Measured with visual analogue scale; 10 cm line, zero: no pain, 10: worst pain, during last week</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quadriceps isometric strength</measure>
    <time_frame>1 year</time_frame>
    <description>Measured with Hand held dynamometer from supine, knee flexed 30 degrees</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disability</measure>
    <time_frame>1 year</time_frame>
    <description>Measured with Aggregate locomotor function score ( sum if 3 timing scires; up and diwn 7 stairs, 8 m walk, rising from chair)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knee Proprioception absolute angular error</measure>
    <time_frame>1year</time_frame>
    <description>Active joint angular reproduction at 30 degree knee flexion from sitting using inclinometer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Lumbar focused + knee focused exercise group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive strengthening of back , abdominal, and quadriceps muscles, and stretching if calf and Hamstring muscles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Knee focused exercise group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Will receive strengthening of quadriceps and stretching of calf and Hamstring muscles</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Lumbar focused exercises</intervention_name>
    <description>Transersus abdominis activation Multifidus activation Back extension exercise Curl up abdominal exercise</description>
    <arm_group_label>Lumbar focused + knee focused exercise group</arm_group_label>
    <other_name>Core training</other_name>
    <other_name>Core stability</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Knee focused exercises</intervention_name>
    <description>Strengthening of quadriceps Stretching of calf and Hamstring muscles</description>
    <arm_group_label>Knee focused exercise group</arm_group_label>
    <arm_group_label>Lumbar focused + knee focused exercise group</arm_group_label>
    <other_name>Traditional knee program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Knee pain for most days of previous month&#xD;
&#xD;
          2. Age 40- 65 years Knee OA grade 2-3 on kellgren- Lawrence grading scale. Unilateral or&#xD;
             bilateral (provided that they radiologically have one knee ≤ grade 1 on KL score, and&#xD;
             clinically pain ≤2 in VAS. The more severally affected knee will be included in&#xD;
             evaluation and treatment) BMI= 25-32 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic hip OA Hip or pelvis trauma Knee or hip infection Congenital or&#xD;
             developmental disorder of lower limbs Intra-articular corticosteroid or hyaluronic&#xD;
             acid injection into the knee within the last 3 months.&#xD;
&#xD;
        Previous surgery of the affected knee or spine. Significant injury to the knee within the&#xD;
        past 6 months. Any disease or medication worsens physical function or hampers with knee&#xD;
        evaluation (e.g. rheumatoid arthritis, canal stenosis..).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohammed S Abdelsalam, Ass prof</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr AlAiny hospital, Cairo university</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>30267667</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Adel Motawea Elsayed Zedan</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Knee osteoarthritis</keyword>
  <keyword>Lumbar core strengthening exercises</keyword>
  <keyword>Dpinal stabilization training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04458753
org study id: 012/002731
nct id: NCT04458753
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
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 weeks
primary purpose: Treatment
masking: Single (Participant)
masking description: Patients will not know in which group they assigned
measure: Average Knee Pain during last week
time frame: 1year
description: Measured with visual analogue scale; 10 cm line, zero: no pain, 10: worst pain, during last week
measure: Quadriceps isometric strength
time frame: 1 year
description: Measured with Hand held dynamometer from supine, knee flexed 30 degrees
measure: Disability
time frame: 1 year
description: Measured with Aggregate locomotor function score ( sum if 3 timing scires; up and diwn 7 stairs, 8 m walk, rising from chair)
measure: Knee Proprioception absolute angular error
time frame: 1year
description: Active joint angular reproduction at 30 degree knee flexion from sitting using inclinometer
arm group label: Lumbar focused + knee focused exercise group
arm group type: Experimental
description: Will receive strengthening of back , abdominal, and quadriceps muscles, and stretching if calf and Hamstring muscles
arm group label: Knee focused exercise group
arm group type: Active Comparator
description: Will receive strengthening of quadriceps and stretching of calf and Hamstring muscles
intervention type: Other
intervention name: Lumbar focused exercises
description: Transersus abdominis activation Multifidus activation Back extension exercise Curl up abdominal exercise
arm group label: Lumbar focused + knee focused exercise group
other name: Core training
other name: Core stability
intervention type: Other
intervention name: Knee focused exercises
description: Strengthening of quadriceps Stretching of calf and Hamstring muscles
arm group label: Knee focused exercise group
arm group label: Lumbar focused + knee focused exercise group
other name: Traditional knee program
criteria: 
gender: All
minimum age: 40 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mohammed S Abdelsalam, Ass prof
role: Study Chair
affiliation: Cairo University
facility: 
country: Egypt
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.
PMID: 30267667
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Adel Motawea Elsayed Zedan
investigator title: Principal investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No