Patellofemoral Pain SyndromeNCT04667091
Comparing the Effects of Positional Release Technique Versus Myofascial Release Technique of Gluteus Medius
A study testing Physiotherapy in people with Patellofemoral Pain Syndrome, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 7 Dec 2020to 24 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pelvic malalignment
- Flat foot
- Chondromalacia patellae
- Young onset Osteoarthritis
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sindh Institute of Physical Medicine and Rehabilitation, Karachi
Karachi, Sindh, 74200
About this study
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
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.
Read the 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.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Physiotherapy
- Keywords
- Anterior knee pain, Gluteus medius, trigger point therapy
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Physiotherapy |
| Comparator | Active 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 Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and end of intervention (6th week)
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.
Measured: Baseline and end of intervention (6th week)
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.)
Measured: Baseline and end of intervention (6th week)
Secondary outcomes (2)
Muscle strength
In kilograms (kg.) obtained by Hand Held Dynamometer
Measured: Baseline and end of intervention (6th week)
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.
Measured: Baseline and end of intervention (6th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start7 Dec 2020
- Primary completion15 Mar 2021
- Study completion24 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priyanka Ratan Kumar, Dow University of Health Sciences
- Investigators
- Priyanka Kumar, MSAPT, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667091
- Sponsor's protocol ID
- IRB-1542
- Status last verified
- Mar 2021
- First submitted
- 3 Dec 2020
- Last updated
- 25 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results will be explored through publications.
Publications
Kumar PR, Soomro RR. Comparing the effects of positional versus myofascial release of gluteus medius to manage patellofemoral pain syndrome: single blinded randomized clinical trial. J Pak Med Assoc. 2024 Feb;74(2):216-223. doi: 10.47391/JPMA.8654.
PubMed 38419216
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04667091
- Acronym / sponsor ID
- IRB-1542
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Anterior knee pain, Gluteus medius, trigger point therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: PhysiotherapyFollowing 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 |
| Comparator | Active comparator | Other: PhysiotherapyFollowing 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Dislocation of Patella
- Damaged cartilage and ligament of Knee Joint
- Soft tissue injury related to Knee
- Any knee or hip surgery
- Lumbar spine dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyTreatment 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) | Other | Comparator, Experimental |
Primary outcome
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.
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.
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.)
2 secondary outcomes
Muscle strength
Time frame: Baseline and end of intervention (6th week)
World Health Organization Quality of Life Questionnaire- Brief
Time frame: Baseline and end of intervention (6th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2021.
- Derived from this study: PubMed 38419216Kumar PR, Soomro RR. Comparing the effects of positional versus myofascial release of gluteus medius to manage patellofemoral pain syndrome: single blinded randomized clinical trial. J Pak Med Assoc. 2024 Feb;74(2):216-223. doi: 10.47391/JPMA.8654.
- Individual participant dataSharing planned: Yes. Results will be explored through publications.
Related trials for Patellofemoral Pain Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priyanka Kumar, MSAPT principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Patellofemoral Pain Syndrome, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior Knee pain Scale (time frame: Baseline and end of intervention (6th week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04667091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2021.