NCT06674707

Brief Summary

Patellofemoral pain syndrome (PFPS) is referred to as peripatellar or retro-patellar pain, which is characterized by alterations in the physical and biomechanical features of the patellofemoral joint. Risk factors for PFPS include: anatomic anomalies, mal-alignment and altered biomechanics of the lower extremity, muscle dysfunction, patellar hypermobility, poor quadriceps, or iliotibial band flexibility, surgery, tight lateral structures, training errors or overuse and trauma. The aim of this study is to compare the effects of foot mobilization with and without agility training on pain, balance and functional performance in patellofemoral pain syndrome.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
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

January 4, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 5, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2025

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 3, 2024

Last Update Submit

November 3, 2024

Conditions

Keywords

BalanceFunctional PerformanceFlat footKujala function scalePatellofemoral pain syndromePain

Outcome Measures

Primary Outcomes (4)

  • Numeric Pain Rating Scale (NPRS):

    The outcome was the 11-point NPRS to measure pain intensity. The NPRS defines pain intensity from 0 to 10 points, with 0 and 10 points indicating no pain and the most severe pain respectively. The reported test-retest reliability (intraclass correlation coefficient \[ICC\]) was 0.76, demonstrating it to be a good indicator of pain intensity.

    6 weeks

  • Kujala Patellofemoral Pain Scale

    Anterior knee pain scale is frequently referred as Kujala scale. It's a 13 item questionnaire including different items on pain related to function and activities. The items assessed in the questionnaire are patellar subluxation, claudication, pain, walking, climbing stairs and prolonged sitting with the knees flexed. It has a score from 0 to 100 points, where 100 means without pain and functional limitations and 0 means constant pain and various functional limitations.

    6 weeks

  • Y Balance Test

    The YBT assesses the balance by challenging his postural control system in 3 (anterior, posteromedial, and posterolateral) of the 8 SEBT (star excursion balance test) directions and has been advocated as a method for assessing dynamic balance (requires strength, flexibility and proprioception). The Y balance score was calculated by dividing the sum of the maximum reach distance in the anterior (A), posteromedial (PM), and posterolateral (PL) directions by 3 times the limb length (LL) of the individual, then multiplied by 100.

    6 weeks

  • Navicular Droop Test

    Position the patient in standing so there is full weight-bearing through the lower extremity and ensure the foot is in the subtalar joint neutral position ("talar head congruent"). Mark the most prominent part of the navicular tuberosity and measure its distance from the supporting surface floor or step. Ask the patient to relax and then measure the amount of sagittal plane excursion of the navicular with a ruler. Alternatively, the test can also be performed in reverse, measuring from relaxed position up to talar neutral in standing postion. Many clinicians also choose to perform this test by marking the start and end position of the navicular on an index card placed along the inside of the foot and then measure the change with a ruler. The ICC2,1 values in the sitting and standing positions were 0.93 and 0.95, respectively, indicating significantly high inter-rater reliability.

    6 weeks

Study Arms (2)

Agility Training with Foot Mobilization

EXPERIMENTAL

Agility Training with Foot Mobilization along with simple conventional treatment

Other: Agility Training with Foot mobilization.

Agility Training without Foot Mobilization.

ACTIVE COMPARATOR

Agility training without foot mobilization along with simple conventional treatment.

Other: Agility Training without Foot mobilization

Interventions

Agility training with foot mobilization with the frequency of 3 sets of 10 repetitions thrice per week for a total six weeks. Pre and post intervention values will be taken on 1st day and after six weeks. Agility training includes side stepping, braiding activities, and front and back crossover steps during forward ambulation, shuttle walking, multiple changes in direction during walking on therapist command. TJM is a grade III Maitland technique and is applied with a high amplitude from the end range and 1s of vibration in the middle range of the joint through a linear motion to where tissue resistance is felt in the prone position, the patient is supported by a towel placed under the foot. Two sets of 5 min total were performed for 6weeks.

Also known as: Simple conventional Treatment
Agility Training with Foot Mobilization

Agility training includes side stepping, braiding activities, and front and back crossover steps during forward ambulation, shuttle walking, multiple changes in direction during walking on therapist command. Comprising of Hot pack and TENS for 10 minutes and Ultrasound for 5 minutes . Comprising of conventional exercises were given for 3 sessions per week for 6 weeks. It includes semi squat, quadriceps isometric, terminal knee extension with elastic band, terminal knee extension in supine position, and adductor squeeze in crook lying (squeeze the ball).

Also known as: Simple Conventional Treatment
Agility Training without Foot Mobilization.

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical signs of patellofemoral pain syndrome such as retro patellar pain, crepitation, and pain with patellar grinding more than 6 months.
  • Both genders of 20-40 years of age.
  • Presence of pain on step down from a 25 step or double leg squat and sitting with knee bent greater than 15 min.
  • Pain more than 4 on NPRS scale.
  • Individual with anterior left/right asymmetries greater than 4 cm on Y balance test
  • Excessive calcaneal eversion measured at 6° in the relaxed posture(6).

You may not qualify if:

  • History of ligament and meniscal injury.
  • History of lower limb fractures.
  • History of post-surgical condition of lower limb
  • History of systemic, connective tissue or neurologic condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al- Rehman Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (7)

  • Luza LP, Luza M, Santos GM. Patellofemoral Pain Syndrome Modifies the Movement of the Rearfoot, but It Does Not Alter Plantar Pressure Distribution. Rev Bras Ortop (Sao Paulo). 2020 Aug;55(4):419-425. doi: 10.1055/s-0039-1698802. Epub 2019 Dec 13.

    PMID: 32904777BACKGROUND
  • Gomez Carrion A, de Los Angeles Atin Arratibel M, Morales Lozano MR, Martinez Sebastian C, de la Cruz Torres B, Sanchez-Gomez R. Kinematic Effect on the Navicular Bone with the Use of Rearfoot Varus Wedge. Sensors (Basel). 2022 Jan 21;22(3):815. doi: 10.3390/s22030815.

    PMID: 35161560BACKGROUND
  • Rasti E, Rojhani-Shirazi Z, Ebrahimi N, Sobhan MR. Effects of whole body vibration with exercise therapy versus exercise therapy alone on flexibility, vertical jump height, agility and pain in athletes with patellofemoral pain: a randomized clinical trial. BMC Musculoskelet Disord. 2020 Oct 26;21(1):705. doi: 10.1186/s12891-020-03732-1.

    PMID: 33106162BACKGROUND
  • Adhama AI, Akindele MO, Ibrahim AA. Effects of variable frequencies of kinesthesia, balance and agility exercise program in adults with knee osteoarthritis: study protocol for a randomized controlled trial. Trials. 2021 Jul 21;22(1):470. doi: 10.1186/s13063-021-05386-3.

    PMID: 34289884BACKGROUND
  • Shakouri A, Kamali F, Mohamadi M, Nouhi E. Lumbopelvic manipulation alone versus combined with dry needling in physically active patients with patellofemoral pain syndrome: A randomized clinical trial. J Bodyw Mov Ther. 2024 Jan;37:220-225. doi: 10.1016/j.jbmt.2023.11.024. Epub 2023 Nov 25.

    PMID: 38432809BACKGROUND
  • da Silva Boitrago MV, de Mello NN, Barin FR, Junior PL, de Souza Borges JH, Oliveira M. Effects of proprioceptive exercises and strengthening on pain and functionality for patellofemoral pain syndrome in women: A randomized controlled trial. J Clin Orthop Trauma. 2021 Apr 19;18:94-99. doi: 10.1016/j.jcot.2021.04.017. eCollection 2021 Jul.

    PMID: 33996453BACKGROUND
  • Clifford AM, Dillon S, Hartigan K, O'Leary H, Constantinou M. The effects of McConnell patellofemoral joint and tibial internal rotation limitation taping techniques in people with Patellofemoral pain syndrome. Gait Posture. 2020 Oct;82:266-272. doi: 10.1016/j.gaitpost.2020.09.010. Epub 2020 Sep 15.

    PMID: 32987346BACKGROUND

MeSH Terms

Conditions

Patellofemoral Pain SyndromeFlatfootPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesTalipesFoot Deformities, AcquiredFoot DeformitiesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ali Raza, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2024

First Posted

November 5, 2024

Study Start

January 4, 2024

Primary Completion

January 7, 2025

Study Completion

January 7, 2025

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations