Comparing the Effects of Positional Release Technique Versus Myofascial Release Technique of Gluteus Medius
Primary Purpose
Patellofemoral Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring Anterior knee pain, Gluteus medius, trigger point therapy
Eligibility Criteria
Inclusion Criteria:
- Anterior knee pain >1month and <3 month
- Pain in activities like ascending & descending stairs, running or sports activity & prolonged sitting
- Presence of Gluteus Medius trigger point in the affected limb
- Age group 18-40 years
- Both genders
Exclusion Criteria:
- Dislocation of Patella
- Damaged cartilage and ligament of Knee Joint
- Soft tissue injury related to Knee
- Any knee or hip surgery
- Lumbar spine dysfunction
- Sacroiliac joint dysfunction
- Pelvic malalignment
- Flat foot
- Chondromalacia patellae
- Young onset Osteoarthritis
Sites / Locations
- Sindh Institute of Physical Medicine and Rehabilitation, Karachi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Comparator
Arm Description
Following physiotherapy will be given to the participants in this group for 6 weeks, 2 times a week: 1. Positional Release Technique 2. Ultrasound 3. Cold Packs 4. Hip Strengthening Exercises 5. Knee Strengthening exercises
Following physiotherapy will be given to the participants in this group for 6 weeks, 2 times a week: 1. Myofascial Release Technique 2. Ultrasound 3. Cold Packs 4. Hip Strengthening Exercises 5. Knee Strengthening exercises
Outcomes
Primary Outcome Measures
Anterior Knee pain Scale
It is 13-item questionnaire with different categories relating various levels of individual's current knee function. Score ranges from 1 representing severe disability to 100 representing no disability.
Visual Analog Scale
A subjective psychometric response scale used to measure discrete behavioral or physiological phenomena based on linear numerical gradient in measuring the intensity of pain.
Pain Pressure Threshold
It is the amount of direct pressure required in eliciting a response in pain on a selected area obtained by an Algometer in kilograms (kg.)
Secondary Outcome Measures
Muscle strength
In kilograms (kg.) obtained by Hand Held Dynamometer
World Health Organization Quality of Life Questionnaire- Brief
An integrated instrument used to evaluate health related quality of life. It is a 26-item version of the WHOQOL-100 assessment.
Full Information
NCT ID
NCT04667091
First Posted
December 3, 2020
Last Updated
March 24, 2021
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04667091
Brief Title
Comparing the Effects of Positional Release Technique Versus Myofascial Release Technique of Gluteus Medius
Official Title
Comparing the Effects of Positional Release Technique Versus Myofascial Release Technique of Gluteus Medius in the Management of Patellofemoral Pain Syndrome - A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 24, 2021 (Actual)
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
No
5. Study Description
Brief Summary
Patellofemoral pain syndrome is a condition of misleading diagnosis. It mostly affects individuals with ages between 18-40 years. It is believed that much work has been done on the joint itself in treating the Quadriceps muscles and triggers related to it but now literature is focusing on the segmental involvement, where weakness of the hip abductors and lateral rotators play a major role. Therefore, interventions used for treating this syndrome should include on focusing the hip muscles for trigger point therapy as well as strengthening them in increasing the stability of the hip and pelvis to reduce excessive valgus forces on the knee.
Detailed Description
Literature regarding Gluteus Medius trigger point is quite scarce especially in alleviating the pain related to Patellofemoral Pain Syndrome. The management of Patellofemoral Pain Syndrome includes a segmental treatment, giving special focus to the lateral rotators and abductors of the hip especially Gluteus Medius muscle, rather than treating the Patellofemoral Joint itself. It will help in improving the pain of the subjects suffering from this syndrome effectively, and within a shorter duration of time. It will also provide the practicing physiotherapist with an insight for treating such patients with better outcomes. Myofascial Trigger Points of the Gluteus Medius are important contributing factors in the management of Patellofemoral Pain Syndrome which is identified in a single study as per author's knowledge. But the treatment used to release the trigger point of Gluteus Medius in managing this syndrome has not yet been explored. So, this study will compare two well-known treatments in comprehending which one of the two techniques have better effects on the population to be studied. Written consent will be taken from all the study participants. Simple randomization technique will be used through "Randomization Main" software and randomization sheet will be generated. 60 participants with patellofemoral pain syndrome having Gluteus Medius trigger point will be randomly allocated in two equal group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome
Keywords
Anterior knee pain, Gluteus medius, trigger point therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single blinding will be used in which only the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Following physiotherapy will be given to the participants in this group for 6 weeks, 2 times a week:
1. Positional Release Technique 2. Ultrasound 3. Cold Packs 4. Hip Strengthening Exercises 5. Knee Strengthening exercises
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Following physiotherapy will be given to the participants in this group for 6 weeks, 2 times a week:
1. Myofascial Release Technique 2. Ultrasound 3. Cold Packs 4. Hip Strengthening Exercises 5. Knee Strengthening exercises
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
Treatment will be given in 3 sessions per week for 6 weeks with home exercise program and participants will be provided with exercises sheets to remember the exercises.
The selected outcome measure will be taken on baseline (initial visit) and 6th week (post intervention)
Primary Outcome Measure Information:
Title
Anterior Knee pain Scale
Description
It is 13-item questionnaire with different categories relating various levels of individual's current knee function. Score ranges from 1 representing severe disability to 100 representing no disability.
Time Frame
Baseline and end of intervention (6th week)
Title
Visual Analog Scale
Description
A subjective psychometric response scale used to measure discrete behavioral or physiological phenomena based on linear numerical gradient in measuring the intensity of pain.
Time Frame
Baseline and end of intervention (6th week)
Title
Pain Pressure Threshold
Description
It is the amount of direct pressure required in eliciting a response in pain on a selected area obtained by an Algometer in kilograms (kg.)
Time Frame
Baseline and end of intervention (6th week)
Secondary Outcome Measure Information:
Title
Muscle strength
Description
In kilograms (kg.) obtained by Hand Held Dynamometer
Time Frame
Baseline and end of intervention (6th week)
Title
World Health Organization Quality of Life Questionnaire- Brief
Description
An integrated instrument used to evaluate health related quality of life. It is a 26-item version of the WHOQOL-100 assessment.
Time Frame
Baseline and end of intervention (6th week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Anterior knee pain >1month and <3 month
Pain in activities like ascending & descending stairs, running or sports activity & prolonged sitting
Presence of Gluteus Medius trigger point in the affected limb
Age group 18-40 years
Both genders
Exclusion Criteria:
Dislocation of Patella
Damaged cartilage and ligament of Knee Joint
Soft tissue injury related to Knee
Any knee or hip surgery
Lumbar spine dysfunction
Sacroiliac joint dysfunction
Pelvic malalignment
Flat foot
Chondromalacia patellae
Young onset Osteoarthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priyanka Kumar, MSAPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sindh Institute of Physical Medicine and Rehabilitation, Karachi
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Results will be explored through publications.
IPD Sharing Time Frame
Results will be explored through publications.
IPD Sharing Access Criteria
Results will be explored through publications.
Learn more about this trial
Comparing the Effects of Positional Release Technique Versus Myofascial Release Technique of Gluteus Medius
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