Protocol summary

Study aim
Comparison of unstable seated core postural control training with hip and knee strength training on pain, function and proprioception in patients with patellofemoral pain
Design
This study is a randomized controlled clinical trial with parallel, single blind, randomized block design with Block Randomization. The sample size is 19 persons in each group.
Settings and conduct
The study will be conducted in Shiraz university of Rehabilitation Sciences and the study population (n = 57) will be randomly divided into control and intervention groups . The intervention groups will do exercises for 4 weeks.This is a single-blinded study.The assessor will be blinded to participants group.
Participants/Inclusion and exclusion criteria
Patients with patellofemoral pain complaining gradual anterior knee pain during last 3 months and age between 18 to 45 years old are included. The patients with any previous knee trauma or other pathologies such as meniscus and ligament injuries or spinal disorders such as Scoliosis;Spondylolysthesis or radicular pain are excluded.
Intervention groups
At first both intervention groups will perform stretching exercises then one group will receive hip and knee strengthening exercises for patellofemoral pain , while other intervention group will receive core postural control training using unstable sitting device.Control group will be received no intervention.
Main outcome variables
Pain ,Function,Proprioception

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131225015932N16
Registration date: 2020-04-21, 1399/02/02
Registration timing: prospective

Last update: 2020-04-21, 1399/02/02
Update count: 0
Registration date
2020-04-21, 1399/02/02
Registrant information
Name
Alireza Motealleh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5108
Email address
motealleh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-03-12, 1399/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of unstable seated core postural control training with hip and knee strength training on pain, function and proprioception in patients with patellofemoral pain
Public title
Comparison the effect of trunk training with hip and knee strength training on pain ,function and proprioception in patients with patellofemoral pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18-40 years/old with unilateral patellofemoral pain Anterior knee pain provoked by at least 2 of the following activities:prolonged sitting, ascending or descending stairs, squatting,kneeling, jumping, running Pain on palpation of the medial and lateral patellar facets, and positive patellar grinding test An insidious onset of symptoms not related to trauma for the last 3 months Kujula scores 50-80 Average pain level of at least 3 out of 10 on an NRS during the previous week Active for at least 30 min daily, but not professional athletes
Exclusion criteria:
Other knee joint pathologies such as meniscus and ligament injuries, osteoarthritis and tendon impairments;Self-reported history of patellar subluxation or dislocations; plica syndrome and Osgood-Schlatter disease; trauma in hip; knee or ankle joint Knee surgery within the previous year Radicular pain from other joints including lumbar spine, hip and sacroiliac joints or any pain in sitting position Spinal problems such as fractures; discopathies; spondylolysthesis and previous abdomen surgeries ; vertebral column trauma or surgeries and spinal tumors Metabolic disorders such as Diabetes; neurological, and rheumatology diseases such as Stroke;MS;RA and balance disorders and peripheral Neuropathies Pregnancy Athlete women who participates in a specific sport at least 2 h /day and 3 times a week regularly Scoliosis
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 57
Randomization (investigator's opinion)
Randomized
Randomization description
Samples via Block randomizer application and Block size=3 will be placed in one of the three control groups, the hip and knee strengthening exercises group, or the postural control training group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The physiotherapist who will measure the outcome measures will be blinded to the patient’s allocation group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Rehabilitation school of Shiraz University of Medical Sciences, Abivardi Ave., Chamran Boulevard
City
Shiraz
Province
Fars
Postal code
۳۳۶۶۹-۷۱۹۴۷
Approval date
2020-02-19, 1398/11/30
Ethics committee reference number
IR.SUMS.REHAB.REC.1399.001

Health conditions studied

1

Description of health condition studied
Patellofemoral pain
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders

Primary outcomes

1

Description
Pain intensity
Timepoint
first ;6th ;12th sessions and 1 month after intervention
Method of measurement
Numeric Rate Scale (NRS)

2

Description
Functional steping
Timepoint
First;6th and 12th sessions and 1 month after intervention
Method of measurement
Step down test

3

Description
Function
Timepoint
First;6th;12th sessions and 1month after intervention
Method of measurement
Kujala questioner

Secondary outcomes

1

Description
Lumbar proproiception
Timepoint
First and 12th sessions
Method of measurement
Isokinetic

2

Description
Knee proprioception
Timepoint
First and 12th sessions
Method of measurement
Isokinetic

Intervention groups

1

Description
First intervention group, hip and knee strengthening group: participants will do 3 treatment sessions per week for a period of 1 month stretching exercises for quadriceps, hamstring, illiotibial band and calf muscles (3 repetition, 30 second hold) and quadriceps setting, terminal knee extention, straight leg raise and hip abductor and external rotator strengthening exercise.Each session almost will take time 47 minutes.
Category
Rehabilitation

2

Description
Second intervention group; postural control training exercise group: this group participants will do stretching exercises same as hip and knee strengthening group then patients will be received postural control training exercise using unstable sitting 3 treatment sessions per week for a period of 1 month.Patients will be asked to control their balance on unstable sitting and hold it as long as possible. In order to progress the training, 3 unstable sitting with 3 different diameters (24, 30 and 50 cm) will be provided. Each session will take time 47 min, and 7 sets of 5 min each with a 2-min rest interval between sets will used.
Category
Rehabilitation

3

Description
Control group: This group will be received no intervention.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic of Shiraz School of Rehabilitation
Full name of responsible person
Dr. Alireza Motealleh
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
71947-33669
Phone
+98 71 3843 2206
Email
motealleh@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Qasemi
Street address
Shiraz University of Medical Sciences Building, Zand Street,shiraz.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
دانشگاه علوم پزشکی شیراز
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Ahmadi Ashan
Position
Master science student of Physical Therapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
۳۳۶۶۹-۷۱۹۴۷
Phone
00
Email
Ahmadiii.elham1994@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Alireza Motealleh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
۳۳۶۶۹-۷۱۹۴۷
Phone
+98 71 1626 1081
Email
motealleh@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Elham Ahmadi Ashan
Position
Master of science student in Physical Therapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
۳۳۶۶۹-۷۱۹۴۷
Phone
00
Email
Ahmadiii.elham1994@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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