NCT04667091

Brief Summary

Patellofemoral pain syndrome is a condition of misleading diagnosis. It mostly affects individuals with ages between 18-40 years. It is believed that much work has been done on the joint itself in treating the Quadriceps muscles and triggers related to it but now literature is focusing on the segmental involvement, where weakness of the hip abductors and lateral rotators play a major role. Therefore, interventions used for treating this syndrome should include on focusing the hip muscles for trigger point therapy as well as strengthening them in increasing the stability of the hip and pelvis to reduce excessive valgus forces on the knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

December 3, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

December 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

December 3, 2020

Last Update Submit

March 24, 2021

Conditions

Keywords

Anterior knee painGluteus mediustrigger point therapy

Outcome Measures

Primary Outcomes (3)

  • Anterior Knee pain Scale

    It is 13-item questionnaire with different categories relating various levels of individual's current knee function. Score ranges from 1 representing severe disability to 100 representing no disability.

    Baseline and end of intervention (6th week)

  • Visual Analog Scale

    A subjective psychometric response scale used to measure discrete behavioral or physiological phenomena based on linear numerical gradient in measuring the intensity of pain.

    Baseline and end of intervention (6th week)

  • Pain Pressure Threshold

    It is the amount of direct pressure required in eliciting a response in pain on a selected area obtained by an Algometer in kilograms (kg.)

    Baseline and end of intervention (6th week)

Secondary Outcomes (2)

  • Muscle strength

    Baseline and end of intervention (6th week)

  • World Health Organization Quality of Life Questionnaire- Brief

    Baseline and end of intervention (6th week)

Study Arms (2)

Experimental

EXPERIMENTAL

Following physiotherapy will be given to the participants in this group for 6 weeks, 2 times a week: 1\. Positional Release Technique 2. Ultrasound 3. Cold Packs 4. Hip Strengthening Exercises 5. Knee Strengthening exercises

Other: Physiotherapy

Comparator

ACTIVE COMPARATOR

Following physiotherapy will be given to the participants in this group for 6 weeks, 2 times a week: 1\. Myofascial Release Technique 2. Ultrasound 3. Cold Packs 4. Hip Strengthening Exercises 5. Knee Strengthening exercises

Other: Physiotherapy

Interventions

Treatment will be given in 3 sessions per week for 6 weeks with home exercise program and participants will be provided with exercises sheets to remember the exercises. The selected outcome measure will be taken on baseline (initial visit) and 6th week (post intervention)

ComparatorExperimental

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Anterior knee pain \>1month and \<3 month
  • Pain in activities like ascending \& descending stairs, running or sports activity \& prolonged sitting
  • Presence of Gluteus Medius trigger point in the affected limb
  • Age group 18-40 years
  • Both genders

You may not qualify if:

  • Dislocation of Patella
  • Damaged cartilage and ligament of Knee Joint
  • Soft tissue injury related to Knee
  • Any knee or hip surgery
  • Lumbar spine dysfunction
  • Sacroiliac joint dysfunction
  • Pelvic malalignment
  • Flat foot
  • Chondromalacia patellae
  • Young onset Osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sindh Institute of Physical Medicine and Rehabilitation, Karachi

Karachi, Sindh, 74200, Pakistan

Location

Related Publications (1)

  • Kumar PR, Soomro RR. Comparing the effects of positional versus myofascial release of gluteus medius to manage patellofemoral pain syndrome: single blinded randomized clinical trial. J Pak Med Assoc. 2024 Feb;74(2):216-223. doi: 10.47391/JPMA.8654.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Priyanka Kumar, MSAPT

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single blinding will be used in which only the researcher doing the study knows which treatment or intervention the participant is receiving until the trial is over.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Priyanka Ratan Kumar (PT)

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 14, 2020

Study Start

December 7, 2020

Primary Completion

March 15, 2021

Study Completion

March 24, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Results will be explored through publications.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Results will be explored through publications.
Access Criteria
Results will be explored through publications.

Locations