Effects of Pelvic Tilt Exercises Along With Hip and Knee Focused Exercises on Patients With Patellofemoral Pain Syndrome

This study is designed as a Randomized Controlled Trial to be conducted at the CRC Department of Chaudhary Muhammad Akram Teaching and research Hospital, Lahore.

Study Overview

• Status: Active, not recruiting
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Combination product: Pelvic Tilt, Hip and Knee Focused Exercises (Intervention Group); Diagnostic test: Hip and Knee Focused Exercises(Control Group)

Detailed Description

A total of 48 participants will be recruited accounting for a 10% dropout rate (42+6=48) and equally divided into two groups 24 participants in each group: Group A(Intervention) and Group B(Control). Participants will be selected based on inclusion criteria which includes individuals aged 35-55 years with a clinical diagnosis of Patellofemoral Pain Syndrome (positive Patellar Compression Test) symptoms persisting for at least 6 weeks to 6 months and moderate-to-severe knee pain (NPRS ≥ 4). They must also be willing to comply with study protocols. Exclusion criteria include recent knee surgery, other knee conditions (e.g., ligament injuries or severe osteoarthritis), and neurological disorders affecting movement or cognition.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Superior University CRC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants must have a clinical diagnosis of Patellofemoral Pain Syndrome.
• Participants should be aged between 35 and 55 years, as this is the typical age group affected by PFPS and will help standardize the sample.
• Individuals with a BMI ranging from 18 to 25 kg/m2.
• Participants should have had symptoms of PFPS for at least 6 weeks to 6 months, ensuring the condition is subacute and chronic.
• Knee Pain Severity: Patients must report moderate to severe knee pain (e.g., pain score ≥ 4 on a 0-10 pain scale) to assess the effectiveness of rehabilitation interventions.
• Participants must be willing to engage in the prescribed exercise program and comply with study protocols including follow-up assessments.

Exclusion Criteria:

• Individuals who have undergone knee surgery within the last 6 months, as post-surgical rehabilitation could interfere with the study outcomes and confound results. Patients with other knee conditions, such as ligament injuries (e.g., ACL or MCL tears), meniscal tears or osteoarthritis, which could significantly affect rehabilitation or complicate the assessment of PFPS.
• Individuals with severe knee osteoarthritis (e.g., Kellgren-Lawrence grade 3 or 4) as it may impact the treatment response and differ from the typical PFPS rehabilitation approach.
• Individuals with neurological conditions (e.g., stroke, multiple sclerosis or peripheral neuropathy) that affect movement, balance or cognition making participation in rehabilitation exercises unsafe or difficult.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelvic Tilt, Hip and Knee Focused Exercises (Intervention Group)	Combination product: Pelvic Tilt, Hip and Knee Focused Exercises (Intervention Group); The treatment program is between one to six weeks with strictly 18 sessions with at least thrice in a week to give room to recuperate from muscle fatigue. This protocol is set in a 45 minutes session that involves a series of exercises and stretches. The quadriceps muscles strengthening exercises, hamstring and the calf raising workouts such as the hamstring curls and heel raise are done in 3 sets of 10-15 reps. Patellofemoral joint mobilization which should not last more than 2-3 minutes due to possible patient discomfort is performed and its primary goal is increasing joint mobility. After that the patient is to perform exercises for pelvic tilt in three approaches, each made in 10 to 15 repetitions.
Active Comparator: Hip and Knee Focused Exercises(Control Group)	Diagnostic test: Hip and Knee Focused Exercises(Control Group); The treatment program covers a time frame of one to six weeks, three sessions a week, total of 18 sessions, over six weeks. Each session takes 45 minutes and contains a schedule of activities. The quadriceps muscles strengthening exercises, hamstring and the calf raising workouts such as the hamstring curls and heel raise are done in 3 sets of 10-15 reps. Patellofemoral joint mobilization which should not last more than 2-3 minutes due to possible patient discomfort is performed and its primary goal is increasing joint mobility. Then Patient performs hip exercises; hip abductor as well as hip extension, which are done in three sets of 10 to 15 repetitions each. Likewise, the knee-focused workouts such as quad sets, straight leg raises and step-up are conducted in the same 3 sets of 10-15 repetitions style. Static flexibility exercises includes Hip Flexor Stretch, IT Band Stretch and these exercises are performed with 5 sets of 30 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patellar Grind Test	The Patellar Grind Test, also known as Clarke's Sign, is a physical examination used to assess patellofemoral joint pain, involving compression of the patella while the patient contracts their quadriceps, with a positive test indicated by pain or grinding	12 Months
Numeric Pain Rating Scale (NPRS)	Knee Pain during Daily Activities and Exercises is assessed using the numeric pain rating scale for Pain. It is highly reliable based on construct validity and it really measures the degrees of pain and possess significant test-retest reliability. The lowest value, 0, means that the patient felt no pain at all. The highest value 10, means the worse pain that could be conceived.	12 Months
Kujala Patellofemoral Score (Anterior Knee Pain Scale)	Kujala Patellofemoral Score better known as Anterior Knee Pain Scale is self-administered questioner aimed at quantifying the severity of AKP and restriction in activity related to PFPS. It has 13 questions which are focused on certain activity or symptom. Scoring: Each question is scored, and the total ranges from 0 to 100: 0: Higher severity of the symptoms and higher degree of self-implemented limitations. 100: No symptoms, normal function. Interpretation of Scores. 85-100: Perfect working, few indications. 70-84: Good function, mild symptoms. 50-69: Sufficient function, phenomena slightly manifesting themselves. Below 50: Low, worst.	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): June 20, 2025
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: March 29, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mental Disorders; Pathologic Processes; Joint Diseases; Disease; Somatoform Disorders; Syndrome; Patellofemoral Pain Syndrome
• Other Study ID Numbers: MSRSW/Batch-Fall23/797

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No