Developmental of Clinical Prediction Rule for Females Responding to Proximal Control Exercises

September 1, 2020 updated by: Khaled Alaa Eldin, Cairo University

Development of Clinical Prediction Rule for Classifying Females With Patellofemoral Pain Syndrome Who Respond to Proximal Control Exercises

the aim of study is to investigate the effect of body mass index (BMI), age, duration of symptoms, pain severity and knee angle valgus on patient̕̕s response to proximal control exercises.

Study Overview

Detailed Description

Patellofemoral pain syndrome (PFPS) is recognized as one of the most common lower-extremity disorders encountered by orthopaedic physical therapists. Females were 2.23 times more likely to develop PFPS than males. Various authors have suggested that hip weakness may be an impairment associated with PFPS, because poor hip control may lead to abnormal lower extremity or patellofemoral motions. Clinical prediction rules (CPRs) are tools designed to improve decision making in clinical practice by assisting practitioners in making a particular diagnosis, establishing a prognosis, or matching patients to optimal interventions.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 18 to 35 years.
  • Anterior or retropatellar knee pain of non-traumatic origin that was greater than six weeks duration and provoked by at least two predefined activities (prolonged sitting or kneeling, squatting, jogging or running, hopping, jumping, or stair walking).
  • Pain on palpation of the patellar facets, or with step down from a 15 cm step, or double leg squat.

Exclusion Criteria:

  1. Concomitant injury or pathology of other knee structures.
  2. Previous knee surgery.
  3. patellofemoral instability (history of sublaxation or dislocation; positive apprehension test).
  4. knee joint effusion.
  5. Osgood-Schlatter's.
  6. hip or lumbar spine pain (local or referred).
  7. physiotherapy within previous year; prior foot orthoses treatment or use of anti inflammatories or corticosteroids.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: group will receive proximal control exercises

study investigates the effectiveness of proximal control exercises for patients with PFPS in improving pain and function. The findings of this systematic review are consistent with previous evidence reporting effectiveness of exercise for PFPS. In particular, there is consistent moderate to high quality evidence (three RCT, one CCT, three cohort studies, and one case series) that proximal interventions provide relief of pain and improved function in the short term, whereas the knee programs have variable effectiveness. Physical therapists should consider using proximal interventions for early stage treatment for PFPS (Peters et al., 2013).

After 4 weeks of a combined knee and hip strengthening exercise program, sedentary females with PFPS had a greater reduction in pain during stair descent compared to the group who performed knee strengthening exercises only. Both groups also showed significant improvement in function and pain during stair ascent (Fakuda et al., 2010).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of pain
Time Frame: baseline
visual analogue scale 100-mm horizontal line anchored by word descriptors at each end by no the left and worst imaginable pain on the right
baseline
functional status
Time Frame: baseline
Kujala questionnaire is a 13-items knee specific self-report questionnaire. It documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting, and sitting for prolonged periods with knees bent), as well as symptoms such as limp, inability to bear weight through the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion. This questionnaire was used to ssess the individual's functional status and PFPS experienced during specific functional tasks.
baseline
Dynamic knee valgus 2d frontal plane projection angle
Time Frame: baseline
2D frontal plane projection angle (FPPA) analysis to measure dynamic knee valgus. for 2D FPPA analysis, the centers of each of hip, knee and ankle joints will be determined using a standard tape measure, markers will be placed at the midpoint of the ankle malleoli for the center of the ankle joint, midpoint of the femoral condyles to approximate the center of the knee joint, and on the proximal thigh at the midpoint of the line from the anterior superior iliac spine to the knee joint center.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
isometric muscle power of hip abductor and external rotation
Time Frame: baseline
Hand held dynamometer will be used to asses isomteric hip abductor and isometric hip external rotator power
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 3, 2020

Primary Completion (ANTICIPATED)

April 30, 2021

Study Completion (ANTICIPATED)

August 30, 2021

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (ACTUAL)

July 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PFPS clinical prediction rule

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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