NCT06439251

Brief Summary

The patellofemoral pain syndrome (PFPS) is a common cause for "anterior knee pain" and mainly affects young women. the effectiveness of Mulligan technique with or without diclofenac phonophoresis on pain, range of motion and functional disability of knee joint in patients with patellofemoral pain syndrome is known little. This study, ethically approved, focused on patients with anterior knee pain referred to the Physical Therapy Department from Lahore General Hospital. After eligibility assessments and consent, participants were randomly assigned to Group A (Experimental) or Group B (Control). Over four weeks, three sessions per week, routine physiotherapy and specific exercises will be administered, with Group A receiving additional Phonophoresis using ultrasound and diclofenac gel. Outcome variables (Numeric Pain Rating Scale, KOOS-PF, Universal Goniometer) will be assessed by a blinded assessor at baseline and study completion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

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

October 18, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

February 27, 2024

Last Update Submit

August 4, 2025

Conditions

Keywords

Patellofemoral Pain Syndrome,Mulligan mobilizationPhonophoresisdiclofenac

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale

    The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

    4 weeks

  • KOOS-PF Scale

    KOOS-PF is a subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS) that specifically measures symptoms and function related to patellofemoral pain and osteoarthritis. It was developed to provide a more detailed assessment in this specific knee condition. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. This direction, 100 indicating no problems.

    4 weeks

  • Universal Goniometer

    It has a scale for the measurement of the angle. The scale can extend from 0 to 180 degrees for half-circle models or 0 to 360 degrees for full-circle models.

    4 weeks

Study Arms (2)

Diclofenac Phonophoresis

EXPERIMENTAL

The participants randomly allocated in Group A were receive the Phonophoresis (Ultrasound with Diclofenac gel for 5 minutes and intensities 1 MHz and 1.5 W/cm² pulsed waves was used in the therapy sessions on affected knee with diclofenac gel on ultrasound head) as experimental technique

Combination Product: Group 1

Mulligan Technique

ACTIVE COMPARATOR

The treatment involved routine physiotherapy with TENS at 80 Hz and a pulse duration of 50-100 μs, followed by a 15-minute hot pack. It also included stretching exercises for the hamstring and calf muscles, isometric strengthening of the quadriceps and VMO, straight leg raises with traction, and tibial gliding techniques. The MWM technique consisted of SLR with traction, repeated 10 times with 3 sets and a 1-minute interval in between.

Combination Product: Group 2

Interventions

Group 1COMBINATION_PRODUCT

The treatment included TENS therapy, hot pack application, stretching exercises, isometric strengthening, straight leg raises with traction, and tibial gliding techniques. Participants in Group A also received Phonophoresis as an experimental technique.

Diclofenac Phonophoresis
Group 2COMBINATION_PRODUCT

The treatment included routine physiotherapy with TENS, hot pack application, stretching exercises, isometric strengthening, straight leg raises with traction, and tibial gliding techniques.

Mulligan Technique

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of age range 20-45 years and both genders (Rehman, 2021 #171)
  • Unilateral anterior knee pain persisting for over two months, referred by orthopedic (Rehman, 2021 #171)
  • Pain scoring rate on numeric pain rating scale (NPRS) \>3 during at least two activities (Rehman, 2021 #171)
  • Patients with positive Clarke's test/ Patellar grind test (Rehman, 2021 #171)
  • Pain while going up and down stairs, when sitting with knees flexed and with squatting, kneeling or returning from squat. (Powers, 2017 #172)

You may not qualify if:

  • Patients with other knee pathologies; meniscus tears, bursitis, patellar tendon injury, ligamentous injury
  • Degenerative joint disorders; knee osteoarthritis, rheumatoid arthritis etc.
  • Patellofemoral dislocation and / or frequent subluxation.
  • Patients having undergone lower extremity surgery
  • Those taking any pain medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore General Hospital

Lahore, Punjab Province, 57000, Pakistan

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Zunaira Saeed, Masters

    University of Lahore

    PRINCIPAL INVESTIGATOR
  • Umber Nawaz, PhD Scholar

    University of Lahore

    PRINCIPAL INVESTIGATOR
  • Ashfaq Ahmad, PhD

    University of Lahore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2024

First Posted

June 3, 2024

Study Start

October 18, 2023

Primary Completion

June 15, 2025

Study Completion

July 20, 2025

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

After the completion of the study

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After the completion of the study, tentatively in 2025
Access Criteria
by email

Locations