- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07716163
Mikhled Knee Exercise Program With and Without Stecco Fascial Manipulation Effect in Patellofemoral Pain Syndrome (MKEP)
Comparative Effects of the Mikhled Knee Exercise Program With and Without Stecco Fascial Manipulation on Pain, Range of Motion, and Functional Outcomes in Patellofemoral Pain Syndrome
Study Overview
Status
Detailed Description
A study was conducted to assess the comparative effectiveness of the Mikhled Knee Exercise Program (MKEP) combined with ultrasound therapy and conventional physiotherapy combined with ultrasound therapy in managing patellofemoral arthritis. Thirty participants diagnosed with patellofemoral arthritis were randomly assigned to two groups: an MKEP group (n = 15) and a conventional therapy group (n = 15). The MKEP group received the Mikhled Knee Exercise Program along with ultrasound therapy, while the conventional group received traditional physiotherapy exercises with ultrasound therapy. Both groups underwent a 6-week intervention. Pain was assessed using the Numerical Pain Rating Scale (NPRS), and functional status was evaluated using the Anterior Knee Pain Scale (AKPS) before and after treatment. The findings demonstrated that the Mikhled Knee Exercise Program combined with ultrasound therapy was more effective than conventional physiotherapy with ultrasound therapy in reducing pain and improving functional status among patients with patellofemoral arthritis.
A randomized study was conducted to determine the effects of the Mikhled Knee Exercise Program and quadriceps-based training in collegiate athletes with patellofemoral pain syndrome. Fifty-four participants were randomly allocated into two equal groups. During a four-week intervention, one group received the Mikhled Knee Exercise Program, whereas the other group underwent quadriceps-based training. Participants were assessed before and after treatment using the Numerical Pain Rating Scale (NPRS) and the Kujala Patellofemoral Scale. The results indicated that the Mikhled Knee Exercise Program was more effective than quadriceps-based training in reducing pain and improving functional outcomes in individuals with patellofemoral pain syndrome.
A randomized clinical trial was conducted to investigate the efficacy of Fascial Manipulation using the Stecco Method combined with muscle strengthening compared with muscle strengthening alone in patients with patellofemoral pain. Twenty-seven participants were randomly assigned to two groups. One group received supervised muscle strengthening along with Fascial Manipulation using the Stecco Method, whereas the other group received supervised muscle strengthening only. Pain was assessed using the Numeric Rating Scale (NRS), subjective function using the Lower Extremity Functional Scale (LEFS), and objective function using the Step Down Test. Assessments were performed before treatment, after completion of the intervention, and at one-month follow-up. The study demonstrated that combining Stecco Fascial Manipulation with muscle strengthening produced greater improvements than muscle strengthening alone.
A randomized comparative single-blind clinical study was conducted to evaluate the effects of ultrasound therapy, the Mikhled Knee Exercise Program, and their combination in individuals with patellofemoral pain syndrome. Sixty participants aged 20 years or younger were allocated into three groups: Mikhled Knee Exercise Program, ultrasound therapy, and Mikhled Knee Exercise Program combined with ultrasound therapy. Pain was measured using the Visual Analog Scale (VAS), general health was assessed using the SF-36 questionnaire, and functional status was evaluated with the WOMAC questionnaire before and after treatment. The findings showed that combining the Mikhled Knee Exercise Program with ultrasound therapy resulted in greater pain reduction and functional improvement than either intervention alone.
Although the Mikhled Knee Exercise Program has demonstrated effectiveness in addressing muscular impairments associated with patellofemoral pain syndrome, limited evidence exists regarding its integration with fascial techniques such as the Stecco Fascial Manipulation Method. Most existing studies have evaluated exercise-based rehabilitation or fascial/manual therapy as independent interventions, with very few examining the combined therapeutic effects of both approaches. Therefore, further research is warranted to determine whether integrating the Mikhled Knee Exercise Program with Stecco Fascial Manipulation provides superior improvements in pain reduction, joint mobility, and functional outcomes in individuals with patellofemoral pain syndrome.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Dr. Abid Harif Awan's Physiotherapy Clinic
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Contact:
- Saba Rafiq, MS-OMPT
- Phone Number: 03034045433
- Email: saba.rafiq@riphah.edu.pk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female participants between the ages of 25-45 years (16)
- Diffused anterior knee pain for at least 8 weeks (16)
- Pain exacerbated by climbing stairs, prolonged sitting, walking, running, squatting, knee flexion, and isometric quadriceps contraction (14).
- Patients had never received Stecco fascial manipulation and MKEP before.
Exclusion Criteria:
- Tendonitis
- Osgood-Schlatter syndrome
- OA
- Fracture
- Patellar sublaxation or dislocation
- Previous history of surgery
- Meniscus or ligament damage
- Heart diseases
- Neurological deficits
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Mikhled Knee Exercises with Stecco Fascial Manipulation
Participants will receive the Mikhled Knee Exercise Program (MKEP) three times per week for 6 weeks under physiotherapist supervision.
The program includes wall slides, step-downs, eccentric decline squats, lateral step-ups, terminal knee extensions, single-leg stance with trunk rotation, and quadriceps isometric exercises (2-3 sets of 10-15 repetitions), with progressive advancement based on individual tolerance.
In addition, participants will receive Stecco Fascial Manipulation for 10-15 minutes, 1-2 times per week, targeting the Centers of Coordination (CCs) of the hip, thigh, and knee to improve fascial mobility, reduce pain, and enhance knee function.
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Intervention: Mikhled Knee Exercise Program (MKEP) Frequency: 3 sessions per week Duration: 6 weeks Session Duration: 30-45 minutes Supervision: Supervised by a physiotherapist Exercises: Wall slides, step-downs, eccentric decline squats, lateral step-ups, closed kinetic chain terminal knee extensions, single-leg stance with trunk rotation, and quadriceps isometric exercises Dosage: 2-3 sets of 10-15 repetitions per exercise Progression: Gradual increase in exercise intensity and difficulty based on participant tolerance and clinical progress. Intervention: Stecco Fascial Manipulation Frequency: 1-2 sessions per week (within the treatment session) Duration: 6 weeks Application Time: 10-15 minutes per session Provider: Performed by a trained physiotherapist Target Area: Centers of Coordination (CCs) in the fascia of the hip, thigh, and knee Technique: Manual fascial manipulation tailored to identified fascial restrictions |
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Experimental: Mikhled Knee Exercises Program (MKEP)
Participants in Group B will also perform the Mikhled Knee Exercise Program three times per week for six weeks, following the same structure and progression as Group A. This includes the same set of functional and strengthening exercises aimed at restoring proper patellar alignment and improving knee function, such as wall slides, step-downs, eccentric squats, lateral step-ups, closed-chain terminal knee extensions, single-leg stance with trunk rotation, and isometric quadriceps holds.
Exercise intensity will begin at two sets of 10 repetitions and gradually increase to three sets of 15 repetitions, with resistance and complexity progressing over time based on the patient's response
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Intervention: Mikhled Knee Exercise Program (MKEP) Frequency: 3 sessions per week Duration: 6 weeks Session Duration: 30-45 minutes Supervision: Supervised by a physiotherapist Exercises: Wall slides, step-downs, eccentric decline squats, lateral step-ups, closed kinetic chain terminal knee extensions, single-leg stance with trunk rotation, and quadriceps isometric exercises Dosage: 2-3 sets of 10-15 repetitions per exercise Progression: Gradual increase in exercise intensity and difficulty based on participant tolerance and clinical progress.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric Pain Rating Scale (NPRS)
Time Frame: 6 weeks
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It is a simple and widely used tool for assessing pain intensity, where patients rate their pain from 0 (no pain) to 10 (worst imaginable pain).
It is highly reliable (ICC ranging from 0.87 to 0.96) and valid for assessing pain associated with knee injuries.
It is sensitive to changes in pain levels over time, making it suitable for both baseline and follow-up assessments
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6 weeks
|
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Range of Motion (Flexion) by Universal Goniometer
Time Frame: 6 weeks
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It is a standard instrument to measure the knee joint's flexion angle.
It is essential for evaluating knee mobility following injury or surgery.
The tool has shown excellent reliability (ICC > 0.90) and good validity when used by trained clinicians.
During measurement, the fulcrum is placed over the lateral epicondyle of the femur.
The stationary arm is aligned with the lateral midline of the femur, pointing toward the greater trochanter, while the movable arm is aligned with the lateral midline of the fibula, pointing toward the lateral malleolus
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6 weeks
|
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Anterior Knee Pain Scale (AKPS)
Time Frame: 6 weeks
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The Anterior Knee Pain Scale, also known as the Kujala Score, is a self-reported questionnaire used to evaluate functional limitations and pain in individuals with patellofemoral disorders.
It includes 13 items assessing activities like walking, squatting, and running.
For knee-related conditions, it demonstrates high reliability (ICC > 0.90) and strong content validity in both clinical and research settings
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6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saba Rafiq, MS OMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/25/0130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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