NCT04458753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2020

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

1.4 years

First QC Date

July 1, 2020

Last Update Submit

March 7, 2022

Conditions

Keywords

Knee osteoarthritisLumbar core strengthening exercisesDpinal stabilization training

Outcome Measures

Primary Outcomes (2)

  • Average Knee Pain during last week

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

    1year

  • Quadriceps isometric strength

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

    1 year

Secondary Outcomes (2)

  • Disability

    1 year

  • Knee Proprioception absolute angular error

    1year

Study Arms (2)

Lumbar focused + knee focused exercise group

EXPERIMENTAL

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

Other: Lumbar focused exercisesOther: Knee focused exercises

Knee focused exercise group

ACTIVE COMPARATOR

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

Other: Knee focused exercises

Interventions

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

Also known as: Core training, Core stability
Lumbar focused + knee focused exercise group

Strengthening of quadriceps Stretching of calf and Hamstring muscles

Also known as: Traditional knee program
Knee focused exercise groupLumbar focused + knee focused exercise group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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..).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr AlAiny hospital, Cairo university

Giza, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Core Stability

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Postural BalanceProprioceptionVestibulocochlear Physiological PhenomenaPhysiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSensationNervous System Physiological Phenomena

Study Officials

  • Mohammed S Abdelsalam, Ass prof

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will not know in which group they assigned
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

June 10, 2020

Primary Completion

October 30, 2021

Study Completion

November 30, 2021

Last Updated

March 9, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations