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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06120920
Other study ID # REC-UOL-545-10-2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date November 30, 2023

Study information

Verified date November 2023
Source University of Lahore
Contact Ashfaq Ahmad, PhD
Phone 0300-9449192
Email ashfaq.ahmad@uipt.uol.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Osteoarthritis (OA) of the knee joint results in chronic pain and functional decline among older adults. Osteoarthritis is a degenerative joint disease with complex etiology that results in loss of normal joint function due to narrowing of the articular cartilage. The pathogenesis of knee OA is the result of interaction between mechanical loading, articular cartilage damage, and incomplete repair mechanisms. These changes eventually cause progressive joint degeneration and failure, leading to chronic knee pain and progressive restriction of knee joint mobility. Core muscle endurance deficiency leads to an increase in the loading of the knee, as well as in knee joint contact force during dynamic movement. Hence, poor core stability may be one of the contributing factors that lead to knee OA development as well as its progression. On the other hand hip muscle weakness has been observed in persons with knee OA and to increase the medial compartment loading on the knee joint. This increases the force on the medial compartment of the stance leg, and the disease starts succeeding. Core stabilization and muscular synergism of the trunk and hip work is an effective way to improve lower limb strength balance and prevent injury. Considering the strength deficits in the hip muscles as well as core muscles, a targeted exercise program for knee osteoarthritis include hip muscle strengthening and core strengthening might reduce the medial compartment loading and improve knee symptoms. Core stability and hip strengthening exercise along with Knee Physical therapy and conventional therapy as a mode of treatment in knee OA and it may help clinicians to treat subjects with knee OA at risk of a decline in muscle strength, range of motion, functional disability and pain.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date November 30, 2023
Est. primary completion date November 21, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility Inclusion Criteria: 1. Age: 40-65 2. Diagnose case of knee OA grade 2, 3. 3. Side of involved leg: right or left. 4. Unilateral knee. 5. Gender both male and female. 6. Pre-diagnostics referred by orthopedics. 7. Able to walk without gait aids. Exclusion Criteria: 1. Inflammatory arthritis 2. Osteoarthritis of the hips 3. Having had previous knee or hip surgery. 4. Patient who had amputated leg and who don't have any lower extremity disorders. 5. Received intra-articular injection within 6 months. 6. Non-steroidal anti-inflammatory drug or cortisone use over an extended period. 7. Patients who had neurological and muscle problem

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assigned 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.
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

Locations

Country Name City State
Pakistan The University of Lahore Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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.
Primary 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.
Primary 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 Timed Up and Go Test (TUG) TUG is used to evaluate function. It assesses the patient's capability to stand from the chair, then walk for three meters, turn, walk back, and sit on the same chair. The TUG is highly responsive and valid to determine alteration in patients with OA of the knee. The minimum clinically important differences (MCID) is reported to be 0.8-1.4s for the TUG in patients with OA of the knee. 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.
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