CClinicalTrials.gg
CompletedNCT04458753Updated Mar 9, 2022

Effect of Lumbar Stabilization on Knee OA

An interventional study of Lumbar focused exercises and Knee focused exercises in Knee Osteoarthritis, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-09.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • Knee osteoarthritis
  • Lumbar core strengthening exercises
  • Dpinal stabilization training
03

In context

Osteoarthritis

4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 80 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
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

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..).

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (actual)

Study arms

  • 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 · Other: Knee focused exercises

  • Active comparator
    Knee focused exercise group

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

    Other: Knee focused exercises

Interventions

  • OtherLumbar focused exercises

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

    Also known as: Core training, Core stability

  • OtherKnee focused exercises

    Strengthening of quadriceps Stretching of calf and Hamstring muscles

    Also known as: Traditional knee program

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What researchers measure

Primary outcomes

  1. Average Knee Pain during last week

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

    Time frame: 1year

  2. Quadriceps isometric strength

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

    Time frame: 1 year

Secondary outcomes

  1. Disability

    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

  2. Knee Proprioception absolute angular error

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

    Time frame: 1year

07

Study locations

1 site
  • Kasr AlAiny hospital, Cairo university
    Giza, Egypt
08

References and documents

Publications

  • 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. PubMed 30267667 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04458753
Lead sponsor
Cairo University
Responsible party
Adel Motawea Elsayed Zedan (Principal investigator, Cairo University) — Principal investigator
First posted
Jul 7, 2020
Start date
Jun 10, 2020
Primary completion
Oct 30, 2021
Completion
Nov 30, 2021
Last update
Mar 9, 2022

Study contacts

Mohammed S Abdelsalam, Ass prof
study chair · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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