Comparing the Effects of Positional Release Technique Versus Myofascial Release Technique of Gluteus Medius

March 24, 2021 updated by: Priyanka Ratan Kumar, Dow University of Health Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Sindh Institute of Physical Medicine and Rehabilitation, Karachi

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental

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
Other: Physiotherapy

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)
Active Comparator: Comparator

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
Other: Physiotherapy

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anterior Knee pain Scale
Time Frame: Baseline and end of intervention (6th week)
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.
Baseline and end of intervention (6th week)
Visual Analog Scale
Time Frame: Baseline and end of intervention (6th week)
A subjective psychometric response scale used to measure discrete behavioral or physiological phenomena based on linear numerical gradient in measuring the intensity of pain.
Baseline and end of intervention (6th week)
Pain Pressure Threshold
Time Frame: Baseline and end of intervention (6th week)
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.)
Baseline and end of intervention (6th week)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: Baseline and end of intervention (6th week)
In kilograms (kg.) obtained by Hand Held Dynamometer
Baseline and end of intervention (6th week)
World Health Organization Quality of Life Questionnaire- Brief
Time Frame: Baseline and end of intervention (6th week)
An integrated instrument used to evaluate health related quality of life. It is a 26-item version of the WHOQOL-100 assessment.
Baseline and end of intervention (6th week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dow University of Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Priyanka Kumar, MSAPT, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-1542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

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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