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Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis, Pes Anserine Bursitis

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Myofascial release
Neuromuscular exercises
Cold pack
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Dow Institute of Physical Medicine and RehabilitationRecruiting
  • Sindh Institute of Physical Medicine and RehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myofascial release + Neuromuscular exercises + Cold pack

Neuromuscular exercises + Cold pack

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 3, 2022
Last Updated
September 28, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05529914
Brief Title
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
Official Title
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Pes Anserine Bursitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myofascial release + Neuromuscular exercises + Cold pack
Arm Type
Experimental
Arm Title
Neuromuscular exercises + Cold pack
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Myofascial release
Intervention Description
It is a type of physical therapy often used to treat myofascial pain syndrome with pressure.
Intervention Type
Other
Intervention Name(s)
Neuromuscular exercises
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Cold pack
Other Intervention Name(s)
Cold pack therapy
Intervention Description
Application of cold pack around the patient's body, and covered with dry towel
Primary Outcome Measure Information:
Title
Change in pain intensity on visual analogue scale after four weeks
Description
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.
Time Frame
Baseline and 4 weeks
Title
Change in range of motion assessed with universal goniometer after four weeks
Description
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.
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Change in functional disability assessed with Knee injury and osteoarthritis outcome score after four weeks.
Description
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.
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rabia Hassan, DPT
Phone
03345448859
Email
rabiahassan096@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aftab A Mirza Baig, MSAPT
Phone
03002739920
Email
ab.dptrm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhan I Khan, PhD
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Dow Institute of Physical Medicine and Rehabilitation
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aftab A Mirza Baig, MSAPT
Phone
03002739920
Email
ab.dptrm@gmail.com
First Name & Middle Initial & Last Name & Degree
Farhan Khan, PhD
Phone
03332209704
Email
farhan.ishaque@duhs.edu.pk
First Name & Middle Initial & Last Name & Degree
Rabia Hassan, DPT
Facility Name
Sindh Institute of Physical Medicine and Rehabilitation
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aftab A Mirza Baig, MSAPT
Phone
03002739920
Email
ab.dptrm@gmail.com
First Name & Middle Initial & Last Name & Degree
Rabia Hassan, DPT
First Name & Middle Initial & Last Name & Degree
Aftab A Mirza Baig, MSAPT

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis

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