NCT06120920

Brief Summary

Knee Osteoarthritis is a chronic degenerative joint disease with complex etiology that results in loss of normal joint function due to damage to the articular cartilage. It is characterized by pain, swelling, inflammation and narrowing in articular cartilage. Hip muscle weakness has been observed in persons with knee OA and poor core stability may be one of the other contributing factors that lead to knee OA development as well as its progression. Core stabilization and muscular synergism of the trunk and hip work is an effective way to improve lower limb strength balance and prevent injury. So the lumbopelvic stability is vital to support loads on the knee joint.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

20 days

First QC Date

November 1, 2023

Last Update Submit

November 1, 2023

Conditions

Keywords

Hip Strengthening ExercisesCore Stability ExercisesRoutine Knee Strengthening ExercisesConventional Physical TherapyPain AssessmentRange of MotionFunctional DisabilityKnee Muscle StrengthTime Up and Go Test

Outcome Measures

Primary Outcomes (4)

  • Pain Assessment

    Pain intensity will be measured using Visual Analogue Scale. It consist of a 100mm line, with to end points, 0 representing no pain and 10 representing pain as bad as it could be possible.

    Pain intensity will be measured at the baseline at the time of recruitment and change in pain intensity will be measured at 3rd and 4th week of interventions

  • Knee Range of Motion

    ROM is measured by goniometer.: A normal range of knee joint is 0 degrees of knee extension (a fully straightened knee) and 135 degrees of knee flexion.A half circle long-arm metallic goniometer, ranging from 0 to 180°, with 1° interval marking was used. It had a central fulcrum, a stationary or fixed arm, and a pivoting or moving arm. Both arms were 30 cm long.

    Knee Range of Motion will be measured as baseline at the time of recruitment and change in range of motion will be measured at 3rd and 4th week of treatment.

  • Functional Disability

    The functional disability assessed by the self-reported questionnaire the Knee injury and Osteoarthritis Outcome Score (KOOS).Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

    Level of Functional Disability will be recorded as baseline at the time of recruitment and change in functional status will be observed at the 3rd and 4th week of intervention.

  • Knee Muscle Strength

    Knee Muscle Strength will be observed by Manual Muscle Testing Scale. This method involves testing key muscles from the lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly 1.Flicker of movement,2.through full range actively with gravity counterbalanced,3.through full range actively against gravity,4.through full range actively against some resistance,5.Through full range actively against strong resistance.

    Knee Muscle Strength will be observed as baseline at the time of recruitment and change in muscle strength will be observed at the 3rd and 4th week of treatment

Secondary Outcomes (1)

  • Timed Up and Go Test (TUG)

    Time Up and Go Test will be observed as baseline at the time of recruitment and change in function will be observed at 3rd and 4th week of treatment.

Study Arms (2)

Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises.

ACTIVE COMPARATOR

Patient will receive Conventional physical therapy include hot pack, Tens and routine knee strengthening exercises with core stability exercises.

Other: Assigned InterventionsOther: Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.

Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.

EXPERIMENTAL

In this group, patient will receive conventional physical therapy include hot pack, Tens and routine knee exercises with hip strengthening exercises

Other: Assigned InterventionsOther: Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.

Interventions

Conventional physical therapy consists of hot pack application and transcutaneous electric stimulation (TENS) and routine knee strengthening exercises in addition with core stability exercises in three sessions per week for 4 weeks. Core stability exercises include bent knee hollow hold, bridging, supine toe tap and knee strengthening exercises include knee flexion strengthening exercises and knee extension isometric exercises.

Also known as: Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises.
Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises.Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.

Conventional physical therapy consists of hot pack application, Tens and routine knee exercise program same as group A and in addition with hip strengthening exercises. Hip strengthening exercises include hip flexion and extension strengthening exercises and hip internal rotation and external rotation and hip adduction and abduction strengthening exercises.C

Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises.Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.

Eligibility Criteria

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

You may qualify if:

  • Age: 40-65
  • Diagnose case of knee OA grade 2, 3.
  • Side of involved leg: right or left.
  • Unilateral knee.
  • Gender both male and female.
  • Pre-diagnostics referred by orthopedics.
  • Able to walk without gait aids.

You may not qualify if:

  • Inflammatory arthritis
  • Osteoarthritis of the hips
  • Having had previous knee or hip surgery.
  • Patient who had amputated leg and who don't have any lower extremity disorders.
  • Received intra-articular injection within 6 months.
  • Non-steroidal anti-inflammatory drug or cortisone use over an extended period.
  • Patients who had neurological and muscle problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54770, Pakistan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Dr.Waqar Afzal, PhD

    University of Lahore

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be unaware of the treatment group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2023

First Posted

November 7, 2023

Study Start

November 1, 2023

Primary Completion

November 21, 2023

Study Completion

November 30, 2023

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Participants data that underlies the results after de-identification.

Shared Documents
STUDY PROTOCOL
Time Frame
Immediately after publication
Access Criteria
Researchers who provide methodological sound proposal

Locations