- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05529914
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
January 7, 2024 updated by: Rabia Hassan, Dow University of Health Sciences
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis: A Randomized Control Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rabia Hassan, DPT
- Phone Number: 03345448859
- Email: rabiahassan096@gmail.com
Study Locations
-
-
Sindh
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Karachi, Sindh, Pakistan, 74200
- Dow Institute of Physical Medicine and Rehabilitation
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Karachi, Sindh, Pakistan, 74200
- Sindh Institute of Physical Medicine and Rehabilitation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Myofascial release + Neuromuscular exercises + Cold pack
|
It is a type of physical therapy often used to treat myofascial pain syndrome with pressure.
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
Application of cold pack around the patient's body, and covered with dry towel
Other Names:
|
Active Comparator: Neuromuscular exercises + Cold pack
|
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
Application of cold pack around the patient's body, and covered with dry towel
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain intensity on visual analogue scale after four weeks
Time Frame: Baseline and 4 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
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Change in range of motion assessed with universal goniometer after four weeks
Time Frame: Baseline and 4 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in functional disability assessed with Knee injury and osteoarthritis outcome score after four weeks.
Time Frame: Baseline and 4 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Farhan I Khan, PhD, Dow University of Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 27, 2022
Primary Completion (Actual)
March 30, 2023
Study Completion (Actual)
April 30, 2023
Study Registration Dates
First Submitted
September 3, 2022
First Submitted That Met QC Criteria
September 3, 2022
First Posted (Actual)
September 7, 2022
Study Record Updates
Last Update Posted (Actual)
January 9, 2024
Last Update Submitted That Met QC Criteria
January 7, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHassan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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