NCT06913426

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

March 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Pelvic Tilt, Hip and Knee Focused Exercises (Intervention Group)

EXPERIMENTAL
Combination Product: Pelvic Tilt, Hip and Knee Focused Exercises (Intervention Group)

Hip and Knee Focused Exercises(Control Group)

ACTIVE COMPARATOR
Diagnostic Test: Hip and Knee Focused Exercises(Control Group)

Interventions

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.

Pelvic Tilt, Hip and Knee Focused Exercises (Intervention 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.

Hip and Knee Focused Exercises(Control Group)

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Superior University CRC

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Papaverine

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

BenzylisoquinolinesAlkaloidsHeterocyclic CompoundsOpiate AlkaloidsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations