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Adding Deep Front Line Myofascial Release to Selected Exercises in Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
exercises
myofascial release
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring myofascial release, Knee osteoarthritis, Deep front line

Eligibility Criteria

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

Inclusion Criteria: Mild to moderate unilateral or bilateral medial tibiofemoral OA grade II-III (K/L). The age of the participants will range from 45 to 60 years old . BMI ranged from 20-30 kg/m2 Exclusion Criteria: Severe knee OA (grade IV according to K/L classification). Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee. Patients receiving oral or injected corticosteroids for the last 3 months . History of knee surgery/fracture. Patients with ACL and meniscus injury

Sites / Locations

  • Hoda Mohamed AhmedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

control group

study group

Arm Description

it will receive selective exercises therapy in the form of strengthening and stretching exercises for selective muscles

it will receive selective exercises therapy in the form of strengthening and stretching exercises for selective muscles plus myofascial release technique of the deep front line

Outcomes

Primary Outcome Measures

pain intensity
The scale that will be used the visual analogue scale;each subject will instructed to record pain intensity on line of 100mm. Starting from no pain on the leftto the most sever pain imaginable on the right Patient will choose the point which describe his pain.the more the score toward the end the more severe pain
function
The Arabic version of reduced Western Ontario and McMasters University Osteoarthritis Index (ArWOMAC) index will be used to measure functional disability.is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): During walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): After first waking and later in the day Physical Function (17 items).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations
rang of motion
using digital inclinometer
joint position sense
using digital inclinometer for target angle 30 degree knee flexion

Secondary Outcome Measures

Full Information

First Posted
April 1, 2023
Last Updated
April 16, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05812898
Brief Title
Adding Deep Front Line Myofascial Release to Selected Exercises in Patients With Knee Osteoarthritis
Official Title
Effects of Adding Deep Front Line Myofascial Release to Selected Exercises in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
the aim of the study is to investigate the effect of deep front line myofascial release to selected exercises in patients with knee osteoarthritis
Detailed Description
: Knee osteoarthritis (KOA) also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage. The myofascial meridian is a new approach to the facial restriction .the knee capsules, the adductor muscles and the tipialis posterior are part of the deep front line which is a line of the myofascial meridian. Exercise is the highest evidence in the treatment of knee osteoarthritis. The myofascial release is effective in the treatment of knee osteoarthritis so the study will investigate the effect of adding deep front line myofascial release to selected exercises in patients with knee osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
myofascial release, Knee osteoarthritis, Deep front line

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
exercise plus myofascial release of the adductor and tipialis posterior muscles.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Sham Comparator
Arm Description
it will receive selective exercises therapy in the form of strengthening and stretching exercises for selective muscles
Arm Title
study group
Arm Type
Experimental
Arm Description
it will receive selective exercises therapy in the form of strengthening and stretching exercises for selective muscles plus myofascial release technique of the deep front line
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
strengthening of the gluteus maximus and medius, calf muscles stretching for calf and hamstring muscles
Intervention Type
Other
Intervention Name(s)
myofascial release
Intervention Description
myofascial release using instrument assisted soft tissue mobilization
Primary Outcome Measure Information:
Title
pain intensity
Description
The scale that will be used the visual analogue scale;each subject will instructed to record pain intensity on line of 100mm. Starting from no pain on the leftto the most sever pain imaginable on the right Patient will choose the point which describe his pain.the more the score toward the end the more severe pain
Time Frame
up to four weeks
Title
function
Description
The Arabic version of reduced Western Ontario and McMasters University Osteoarthritis Index (ArWOMAC) index will be used to measure functional disability.is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items): During walking, using stairs, in bed, sitting or lying, and standing upright Stiffness (2 items): After first waking and later in the day Physical Function (17 items).The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations
Time Frame
up to four weeks
Title
rang of motion
Description
using digital inclinometer
Time Frame
up to four weeks
Title
joint position sense
Description
using digital inclinometer for target angle 30 degree knee flexion
Time Frame
up to four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild to moderate unilateral or bilateral medial tibiofemoral OA grade II-III (K/L). The age of the participants will range from 45 to 60 years old . BMI ranged from 20-30 kg/m2 Exclusion Criteria: Severe knee OA (grade IV according to K/L classification). Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee. Patients receiving oral or injected corticosteroids for the last 3 months . History of knee surgery/fracture. Patients with ACL and meniscus injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hoda hussin, bachelor
Phone
0201123692037
Email
pthoda94@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
hoda Ahmed, bachelor
Phone
0201123692037
Email
pthoda94@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hoda m Ahmed, bachelor
Organizational Affiliation
phyical therapist at Cairo university hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoda Mohamed Ahmed
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hoda m Ahmed, bachelor
Phone
0201123692037
Email
pthoda94@gmail.com
First Name & Middle Initial & Last Name & Degree
hoda Ahmed, bachelor
Phone
0201123692037
Email
pthoda94@gmail.com

12. IPD Sharing Statement

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Adding Deep Front Line Myofascial Release to Selected Exercises in Patients With Knee Osteoarthritis

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