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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05529914
Other study ID # RHassan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 27, 2022
Est. completion date April 30, 2023

Study information

Verified date January 2024
Source Dow University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized control trial will be conducted at the outpatient department of Dow Institute of Physical Medicine and Rehabilitation. A sample size of 80 is calculated using PASS version 11 software. The subjects will be first screened and those who fulfill the inclusion criteria, will be asked to fill the consent form. After selection, the participants will be randomly allocated by the help of computer generated randomization sheet, into two groups i.e. experimental and the control group. The group A will be provided with the myofascial release along with the neuromuscular training whereas the group B will only receive the neuromuscular training. Cold pack will be applied to both the groups. The neuromuscular training consists of warm-up phase, lunges, sideways exercises, wall squats, weight transfer exercises, step up and down and the cool down phase. Total 12 sessions of 35 minutes each will be given to all the participants for about 4 weeks on alternate days. Outcome measures will be analyzed by visual analogue scale (VAS) for pain assessment, goniometry for range of motion and the Knee injury and Osteoarthritis Outcome Score (KOOS) to evaluate the functional assessment of the patients at the baseline and the post intervention.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Male and Females both with the age between 40-60 years. - Patients with unilateral or bilateral knee osteoarthritis with pes anserine syndrome. - Patients with knee pain more than 3.4 cm on visual analogue scale as minimum cut of value. - Kellgren and Lawrence grade II and III on radiological findings. - Duration of knee osteoarthritis more than 3 months (chronic). Exclusion Criteria: - Patients with any neurological disorder. - Knee deformities such as contractures, genu valgum and genu varum. - Septic knee arthritis. - History of ligamentous injury or meniscal tear. - Cancer or any other malignancy or bone tumor. - Any history of previous lower limb arthroplasty or other knee surgery. - Comorbid like diabetes mellitus. - Inflammatory rheumatic disease (R.A).

Study Design


Intervention

Other:
Myofascial release
It is a type of physical therapy often used to treat myofascial pain syndrome with pressure.
Neuromuscular exercises
Exercises commonly utilized in neuromuscular training programs to improve strength, balance , speed and agility. It will comprised of Warm-up, Lunges, Sideways exercises, Wall squats, Weight transfer exercise, Step up & down, Cool-down
Cold pack
Application of cold pack around the patient's body, and covered with dry towel

Locations

Country Name City State
Pakistan Dow Institute of Physical Medicine and Rehabilitation Karachi Sindh
Pakistan Sindh Institute of Physical Medicine and Rehabilitation Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pain intensity on visual analogue scale after four weeks The Visual Analogue Scale is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between pains with similar conditions.. It is 0 to 10 cm scale. Patients rate their pain on that scale. Higher the score in centimeter, severe will be the pain experienced. Baseline and 4 weeks
Primary Change in range of motion assessed with universal goniometer after four weeks The Goniometer is an instrument for the precise measurement of range of movement angles in degree , especially one used to measure the angles before and after range of motion.. Increase in the degree of angle suggests increase in range of movement. Baseline and 4 weeks
Secondary Change in functional disability assessed with Knee injury and osteoarthritis outcome score after four weeks. The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems regarding functional disability. In consists of total 100 scores. Increase in scores suggests decreased functional disability and decrease in scores suggests increased functional disability. Baseline and 4 weeks
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